338. 進行性家族性肝内胆汁うっ滞症 Disease details / Clinical trials / Drug dev / DR info
臨床試験数 : 60 / 薬物数 : 26 - (DrugBank : 6) / 標的遺伝子数 : 2 - 標的パスウェイ数 : 2
薬物ごとの開発者（Primary Sponsor）、臨床試験情報（抜粋）です。
A4250
Albireo
2013 Phase 1 NCT02963077 -
A4250 (1200 µg)
ALBIREO AB
2018 Phase 3 EUCTR2017-002338-21-IT Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
Albireo AB
2019 Phase 3 EUCTR2017-002325-38-BE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002338-21-NL Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002338-21-GB Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002338-21-FR Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002338-21-ES Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002338-21-BE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-SE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-NL Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-IT Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-GB Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-FR Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-ES Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2017-002338-21-SE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2017-002338-21-PL Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2017-002338-21-DE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2017-002325-38-PL Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2017-002325-38-DE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
A4250 (200 µg)
ALBIREO AB
2018 Phase 3 EUCTR2017-002338-21-IT Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
Albireo AB
2019 Phase 3 EUCTR2017-002325-38-BE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002338-21-NL Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002338-21-GB Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002338-21-FR Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002338-21-ES Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002338-21-BE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-SE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-NL Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-IT Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-GB Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-FR Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-ES Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2017-002338-21-SE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2017-002338-21-PL Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2017-002338-21-DE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2017-002325-38-PL Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2017-002325-38-DE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
A4250 (400 µg)
ALBIREO AB
2018 Phase 3 EUCTR2017-002338-21-IT Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
Albireo AB
2019 Phase 3 EUCTR2017-002325-38-BE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002338-21-NL Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002338-21-GB Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002338-21-FR Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002338-21-ES Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002338-21-BE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-SE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-NL Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-IT Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-GB Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-FR Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-ES Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2017-002338-21-SE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2017-002338-21-PL Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2017-002338-21-DE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2017-002325-38-PL Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2017-002325-38-DE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
A4250 (600 µg)
ALBIREO AB
2018 Phase 3 EUCTR2017-002338-21-IT Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
Albireo AB
2019 Phase 3 EUCTR2017-002325-38-BE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002338-21-NL Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002338-21-GB Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002338-21-FR Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002338-21-ES Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002338-21-BE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-SE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-NL Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-IT Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-GB Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-FR Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-ES Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2017-002338-21-SE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2017-002338-21-PL Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2017-002338-21-DE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2017-002325-38-PL Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2017-002325-38-DE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
A4250 (odevixibat)
Albireo
2018 Phase 3 NCT03659916 Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 NCT03566238 Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
CRC (A3384)
Albireo
2013 Phase 1 NCT02963077 -
Eicosapentaenoic acid
Sumida Wataru
2016 - JPRN-jRCTs041180088 Japan;
LUM001
Lumena Pharmaceuticals, Inc.
- Phase 2 EUCTR2013-003833-14-FR France;Poland;United Kingdom;United States;
Mirum Pharmaceuticals, Inc.
2014 Phase 2 NCT02057718 France;Poland;United Kingdom;United States;
2014 Phase 2 EUCTR2013-003833-14-GB France;Poland;United Kingdom;
Mirum Pharmaceuticals, LLC.
- Phase 2 EUCTR2013-003833-14-PL France;Poland;United Kingdom;
Shire Human Genetic Therapies Inc
2015 Phase 2 EUCTR2015-000906-20-GB Australia;Canada;United Kingdom;United States;
MARALIXIBAT CHLORIDE
Mirum Pharmaceuticals Inc
2021 Phase 2 EUCTR2020-004628-40-FR Belgium;France;Poland;United Kingdom;
2021 Phase 2 EUCTR2020-004628-40-BE Belgium;France;Poland;United Kingdom;
- Phase 2 EUCTR2020-004628-40-PL Belgium;France;Poland;United Kingdom;
Mirum Pharmaceuticals Inc.
2020 Phase 3 EUCTR2019-003395-39-HU Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
2020 Phase 3 EUCTR2019-003395-39-GB Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
2020 Phase 3 EUCTR2019-003395-39-FR Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
2020 Phase 3 EUCTR2019-003395-39-AT Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
2020 Phase 2 EUCTR2019-002755-42-GB Australia;Belgium;Canada;France;Poland;Spain;United Kingdom;United States;
2020 Phase 2 EUCTR2019-002755-42-FR Australia;Belgium;Canada;France;Poland;Spain;United Kingdom;United States;
2020 Phase 2 EUCTR2019-002755-42-ES Australia;Belgium;Canada;France;Poland;Spain;United Kingdom;United States;
2019 Phase 3 EUCTR2019-001211-22-HU Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
2019 Phase 3 EUCTR2019-001211-22-GB Argentina;Austria;Belgium;Brazil;Canada;Chile;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Saudi Arabia;Singapore;Turkey;United Kingdom;United States;
2019 Phase 3 EUCTR2019-001211-22-FR Argentina;Austria;Belgium;Brazil;Canada;Chile;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Saudi Arabia;Singapore;Turkey;United Kingdom;United States;
2019 Phase 3 EUCTR2019-001211-22-DE Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
2019 Phase 3 EUCTR2019-001211-22-AT Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2019-003395-39-PL Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2019-003395-39-DE Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2019-003395-39-BE Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2019-001211-22-PL Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2019-001211-22-BE Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
- Phase 2 EUCTR2019-002755-42-PL Australia;Belgium;Canada;France;Poland;Spain;United Kingdom;United States;
- Phase 2 EUCTR2019-002755-42-BE Australia;Belgium;Canada;France;Poland;Spain;United Kingdom;United States;
MRX Drug Substance (formerly Maralixibat , SHP625 or LUM001)
Mirum Pharmaceuticals Inc.
- Phase 3 EUCTR2019-001211-22-BE Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
MRX Drug Substance (formerly Maralixibat, SHP625 or LUM001)
Mirum Pharmaceuticals Inc.
2019 Phase 3 EUCTR2019-001211-22-GB Argentina;Austria;Belgium;Brazil;Canada;Chile;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Saudi Arabia;Singapore;Turkey;United Kingdom;United States;
2019 Phase 3 EUCTR2019-001211-22-DE Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
2019 Phase 3 EUCTR2019-001211-22-AT Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2019-001211-22-PL Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2019-001211-22-BE Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
Maralixibat
Mirum Pharmaceuticals, Inc.
2021 Phase 2 NCT04729751 Belgium;France;Poland;United Kingdom;United States;
2020 Phase 3 NCT04185363 Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Italy;Lebanon;Mexico;Poland;Singapore;United Kingdom;United States;
2019 Phase 3 NCT03905330 Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
2018 Phase 3 NCT03353454 -
Maralixibat (formely SHP625 or LUM001)
Mirum Pharmaceuticals Inc
2021 Phase 2 EUCTR2020-004628-40-FR Belgium;France;Poland;United Kingdom;
2021 Phase 2 EUCTR2020-004628-40-BE Belgium;France;Poland;United Kingdom;
- Phase 2 EUCTR2020-004628-40-PL Belgium;France;Poland;United Kingdom;
Mirum Pharmaceuticals Inc.
2020 Phase 2 EUCTR2019-002755-42-GB Australia;Belgium;Canada;France;Poland;Spain;United Kingdom;United States;
2020 Phase 2 EUCTR2019-002755-42-FR Australia;Belgium;Canada;France;Poland;Spain;United Kingdom;United States;
2020 Phase 2 EUCTR2019-002755-42-ES Australia;Belgium;Canada;France;Poland;Spain;United Kingdom;United States;
- Phase 2 EUCTR2019-002755-42-PL Australia;Belgium;Canada;France;Poland;Spain;United Kingdom;United States;
- Phase 2 EUCTR2019-002755-42-BE Australia;Belgium;Canada;France;Poland;Spain;United Kingdom;United States;
Maralixibat (formerly SHP625 or LUM001)
Mirum Pharmaceuticals Inc.
2019 Phase 3 EUCTR2019-001211-22-HU Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
2019 Phase 3 EUCTR2019-001211-22-FR Argentina;Austria;Belgium;Brazil;Canada;Chile;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Saudi Arabia;Singapore;Turkey;United Kingdom;United States;
Maralixibat (in precedenza SHP625 o LUM001)
Mirum Pharmaceuticals Inc.
2019 Phase 3 EUCTR2019-001211-22-IT Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
Maralixibat chloride
Mirum Pharmaceuticals, Inc.
2014 Phase 2 EUCTR2013-003833-14-GB France;Poland;United Kingdom;
Mirum Pharmaceuticals, LLC.
- Phase 2 EUCTR2013-003833-14-PL France;Poland;United Kingdom;
Maralixibat cloruro
Mirum Pharmaceuticals Inc.
2020 Phase 3 EUCTR2019-003395-39-IT Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
2019 Phase 3 EUCTR2019-001211-22-IT Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
Odevixibat
Albireo
2021 - NCT04483531 United States;
Albireo AB
2018 Phase 3 EUCTR2017-002325-38-SE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
Phenylbutyrate
Juntendo University
2014 - JPRN-UMIN000012782 Japan;
Saiseikai Yokohama City Tobu Hospital
2010 - JPRN-UMIN000003802 Japan;
Questran
Albireo
2013 Phase 1 NCT02963077 -
RFP
Department of Pediatrics, Graduate School of Medical Sciences, Kyushu University
2013 - JPRN-UMIN000017823 Japan;
Rifampicin
Department of Pediatrics, Graduate School of Medical Sciences, Kyushu University
2013 - JPRN-UMIN000017823 Japan;
[14C]-A4250 capsule
Albireo
2017 Phase 1 NCT03082937 United Kingdom;
Albireo
2013 Phase 1 NCT02963077 -
A4250 (1200 µg)
ALBIREO AB
2018 Phase 3 EUCTR2017-002338-21-IT Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
Albireo AB
2019 Phase 3 EUCTR2017-002325-38-BE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002338-21-NL Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002338-21-GB Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002338-21-FR Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002338-21-ES Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002338-21-BE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-SE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-NL Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-IT Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-GB Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-FR Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-ES Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2017-002338-21-SE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2017-002338-21-PL Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2017-002338-21-DE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2017-002325-38-PL Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2017-002325-38-DE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
A4250 (200 µg)
ALBIREO AB
2018 Phase 3 EUCTR2017-002338-21-IT Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
Albireo AB
2019 Phase 3 EUCTR2017-002325-38-BE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002338-21-NL Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002338-21-GB Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002338-21-FR Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002338-21-ES Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002338-21-BE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-SE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-NL Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-IT Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-GB Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-FR Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-ES Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2017-002338-21-SE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2017-002338-21-PL Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2017-002338-21-DE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2017-002325-38-PL Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2017-002325-38-DE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
A4250 (400 µg)
ALBIREO AB
2018 Phase 3 EUCTR2017-002338-21-IT Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
Albireo AB
2019 Phase 3 EUCTR2017-002325-38-BE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002338-21-NL Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002338-21-GB Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002338-21-FR Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002338-21-ES Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002338-21-BE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-SE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-NL Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-IT Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-GB Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-FR Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-ES Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2017-002338-21-SE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2017-002338-21-PL Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2017-002338-21-DE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2017-002325-38-PL Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2017-002325-38-DE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
A4250 (600 µg)
ALBIREO AB
2018 Phase 3 EUCTR2017-002338-21-IT Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
Albireo AB
2019 Phase 3 EUCTR2017-002325-38-BE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002338-21-NL Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002338-21-GB Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002338-21-FR Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002338-21-ES Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002338-21-BE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-SE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-NL Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-IT Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-GB Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-FR Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 EUCTR2017-002325-38-ES Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2017-002338-21-SE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2017-002338-21-PL Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2017-002338-21-DE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2017-002325-38-PL Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2017-002325-38-DE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
A4250 (odevixibat)
Albireo
2018 Phase 3 NCT03659916 Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
2018 Phase 3 NCT03566238 Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
CRC (A3384)
Albireo
2013 Phase 1 NCT02963077 -
Eicosapentaenoic acid
Sumida Wataru
2016 - JPRN-jRCTs041180088 Japan;
LUM001
Lumena Pharmaceuticals, Inc.
- Phase 2 EUCTR2013-003833-14-FR France;Poland;United Kingdom;United States;
Mirum Pharmaceuticals, Inc.
2014 Phase 2 NCT02057718 France;Poland;United Kingdom;United States;
2014 Phase 2 EUCTR2013-003833-14-GB France;Poland;United Kingdom;
Mirum Pharmaceuticals, LLC.
- Phase 2 EUCTR2013-003833-14-PL France;Poland;United Kingdom;
Shire Human Genetic Therapies Inc
2015 Phase 2 EUCTR2015-000906-20-GB Australia;Canada;United Kingdom;United States;
MARALIXIBAT CHLORIDE
Mirum Pharmaceuticals Inc
2021 Phase 2 EUCTR2020-004628-40-FR Belgium;France;Poland;United Kingdom;
2021 Phase 2 EUCTR2020-004628-40-BE Belgium;France;Poland;United Kingdom;
- Phase 2 EUCTR2020-004628-40-PL Belgium;France;Poland;United Kingdom;
Mirum Pharmaceuticals Inc.
2020 Phase 3 EUCTR2019-003395-39-HU Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
2020 Phase 3 EUCTR2019-003395-39-GB Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
2020 Phase 3 EUCTR2019-003395-39-FR Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
2020 Phase 3 EUCTR2019-003395-39-AT Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
2020 Phase 2 EUCTR2019-002755-42-GB Australia;Belgium;Canada;France;Poland;Spain;United Kingdom;United States;
2020 Phase 2 EUCTR2019-002755-42-FR Australia;Belgium;Canada;France;Poland;Spain;United Kingdom;United States;
2020 Phase 2 EUCTR2019-002755-42-ES Australia;Belgium;Canada;France;Poland;Spain;United Kingdom;United States;
2019 Phase 3 EUCTR2019-001211-22-HU Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
2019 Phase 3 EUCTR2019-001211-22-GB Argentina;Austria;Belgium;Brazil;Canada;Chile;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Saudi Arabia;Singapore;Turkey;United Kingdom;United States;
2019 Phase 3 EUCTR2019-001211-22-FR Argentina;Austria;Belgium;Brazil;Canada;Chile;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Saudi Arabia;Singapore;Turkey;United Kingdom;United States;
2019 Phase 3 EUCTR2019-001211-22-DE Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
2019 Phase 3 EUCTR2019-001211-22-AT Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2019-003395-39-PL Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2019-003395-39-DE Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2019-003395-39-BE Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2019-001211-22-PL Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2019-001211-22-BE Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
- Phase 2 EUCTR2019-002755-42-PL Australia;Belgium;Canada;France;Poland;Spain;United Kingdom;United States;
- Phase 2 EUCTR2019-002755-42-BE Australia;Belgium;Canada;France;Poland;Spain;United Kingdom;United States;
MRX Drug Substance (formerly Maralixibat , SHP625 or LUM001)
Mirum Pharmaceuticals Inc.
- Phase 3 EUCTR2019-001211-22-BE Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
MRX Drug Substance (formerly Maralixibat, SHP625 or LUM001)
Mirum Pharmaceuticals Inc.
2019 Phase 3 EUCTR2019-001211-22-GB Argentina;Austria;Belgium;Brazil;Canada;Chile;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Saudi Arabia;Singapore;Turkey;United Kingdom;United States;
2019 Phase 3 EUCTR2019-001211-22-DE Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
2019 Phase 3 EUCTR2019-001211-22-AT Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2019-001211-22-PL Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
- Phase 3 EUCTR2019-001211-22-BE Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
Maralixibat
Mirum Pharmaceuticals, Inc.
2021 Phase 2 NCT04729751 Belgium;France;Poland;United Kingdom;United States;
2020 Phase 3 NCT04185363 Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Italy;Lebanon;Mexico;Poland;Singapore;United Kingdom;United States;
2019 Phase 3 NCT03905330 Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
2018 Phase 3 NCT03353454 -
Maralixibat (formely SHP625 or LUM001)
Mirum Pharmaceuticals Inc
2021 Phase 2 EUCTR2020-004628-40-FR Belgium;France;Poland;United Kingdom;
2021 Phase 2 EUCTR2020-004628-40-BE Belgium;France;Poland;United Kingdom;
- Phase 2 EUCTR2020-004628-40-PL Belgium;France;Poland;United Kingdom;
Mirum Pharmaceuticals Inc.
2020 Phase 2 EUCTR2019-002755-42-GB Australia;Belgium;Canada;France;Poland;Spain;United Kingdom;United States;
2020 Phase 2 EUCTR2019-002755-42-FR Australia;Belgium;Canada;France;Poland;Spain;United Kingdom;United States;
2020 Phase 2 EUCTR2019-002755-42-ES Australia;Belgium;Canada;France;Poland;Spain;United Kingdom;United States;
- Phase 2 EUCTR2019-002755-42-PL Australia;Belgium;Canada;France;Poland;Spain;United Kingdom;United States;
- Phase 2 EUCTR2019-002755-42-BE Australia;Belgium;Canada;France;Poland;Spain;United Kingdom;United States;
Maralixibat (formerly SHP625 or LUM001)
Mirum Pharmaceuticals Inc.
2019 Phase 3 EUCTR2019-001211-22-HU Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
2019 Phase 3 EUCTR2019-001211-22-FR Argentina;Austria;Belgium;Brazil;Canada;Chile;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Saudi Arabia;Singapore;Turkey;United Kingdom;United States;
Maralixibat (in precedenza SHP625 o LUM001)
Mirum Pharmaceuticals Inc.
2019 Phase 3 EUCTR2019-001211-22-IT Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
Maralixibat chloride
Mirum Pharmaceuticals, Inc.
2014 Phase 2 EUCTR2013-003833-14-GB France;Poland;United Kingdom;
Mirum Pharmaceuticals, LLC.
- Phase 2 EUCTR2013-003833-14-PL France;Poland;United Kingdom;
Maralixibat cloruro
Mirum Pharmaceuticals Inc.
2020 Phase 3 EUCTR2019-003395-39-IT Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
2019 Phase 3 EUCTR2019-001211-22-IT Argentina;Austria;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Lebanon;Mexico;Poland;Singapore;Turkey;United Kingdom;United States;
Odevixibat
Albireo
2021 - NCT04483531 United States;
Albireo AB
2018 Phase 3 EUCTR2017-002325-38-SE Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom;United States;
Phenylbutyrate
Juntendo University
2014 - JPRN-UMIN000012782 Japan;
Saiseikai Yokohama City Tobu Hospital
2010 - JPRN-UMIN000003802 Japan;
Questran
Albireo
2013 Phase 1 NCT02963077 -
RFP
Department of Pediatrics, Graduate School of Medical Sciences, Kyushu University
2013 - JPRN-UMIN000017823 Japan;
Rifampicin
Department of Pediatrics, Graduate School of Medical Sciences, Kyushu University
2013 - JPRN-UMIN000017823 Japan;
[14C]-A4250 capsule
Albireo
2017 Phase 1 NCT03082937 United Kingdom;