Somatrogon    (DrugBank: Somatrogon)

1 disease
IDDisease name (Link within this page)Number of trials
78Hypopituitarism7

78. Hypopituitarism    [ 462 clinical trials,   346 drugs,   (DrugBank: 45 drugs),   41 drug target genes,   80 drug target pathways]
Searched query = "Hypopituitarism", "Anterior pituitary hypothyroidism", "Syndrome of abnormal secretion of gonadotropin", "Hyposecretion of gonadotropins", "Adrenocorticotropic hormone deficiency", "ACTH deficiency", "Thyroid-stimulating hormone deficiency", "TSH deficiency", "Growth hormone deficiency", "GH deficiency", "GHD", "CGHD", "AGHD", "Prolactin deficiency", "PRL deficiency"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
7 / 462 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-000918-38-BG
(EUCTR)
16/07/201923/05/2019STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCYA PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY - WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) Growth Hormone Deficiency in Children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Somatrogon
Product Code: PF-06836922
INN or Proposed INN: somatrogon
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Trade Name: Genotropin GoQuick
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Trade Name: Genotropin GoQuick
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
90Phase 3United States;Czech Republic;Slovakia;Bulgaria;United Kingdom
2EUCTR2018-000918-38-SK
(EUCTR)
11/07/201911/02/2019STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCYA PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY - WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) Growth Hormone Deficiency in Children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Somatrogon
Product Code: PF-06836922
INN or Proposed INN: somatrogon
Trade Name: Genotropin GoQuick
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Trade Name: Genotropin GoQuick
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
90Phase 3United States;Czech Republic;Slovakia;Bulgaria;United Kingdom
3EUCTR2018-000918-38-CZ
(EUCTR)
27/06/201920/03/2019STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCYA PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY - WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) Growth Hormone Deficiency in Children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Somatrogon
Product Code: PF-06836922
INN or Proposed INN: somatrogon
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Trade Name: Genotropin GoQuick
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Trade Name: Genotropin GoQuick
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
90Phase 3United States;Czech Republic;Slovakia;Bulgaria;United Kingdom
4EUCTR2018-000918-38-GB
(EUCTR)
16/05/201927/11/2018STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCYA PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY - WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN®) Growth Hormone Deficiency in Children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Somatrogon
Product Code: PF-06836922
INN or Proposed INN: somatrogon
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Trade Name: Genotropin GoQuick
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Trade Name: Genotropin GoQuick
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3United States;Czech Republic;Slovakia;Bulgaria;United Kingdom
5NCT03831880
(ClinicalTrials.gov)
February 7, 201921/12/2018Patient Perception of Treatment Burden in Weekly Versus Daily Growth Hormone Injections in Children With GHDA PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN (REGISTERED)) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCYGrowth Hormone DeficiencyDrug: Genotropin;Drug: somatrogonPfizerNULLCompleted3 Years17 YearsAll87Phase 3United States;Bulgaria;Czechia;Slovakia;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6JPRN-JapicCTI-183963
25/12/201717/05/2018Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone DeficiencyA PHASE 3, OPEN-LABEL, RANDOMIZED, MULTICENTER, 12-MONTH, EFFICACY AND SAFETY STUDY OF WEEKLY MOD-4023 COMPARED TO DAILY GENOTROPIN THERAPY IN JAPANESE PRE-PUBERTAL CHILDREN WITH GROWTH HORMONE DEFICIENCY Treatment of children with growth failure due to growth hormone deficiency (GHD)Intervention name : Somatrogon (Genetical Recombination)
INN of the intervention : somatrogon
Dosage And administration of the intervention : MOD-4023 (investigational treatment): weekly MOD-4023 SC injections for 12 months; initially over the first 6 weeks, MOD-4023 will be administered in 3 stepwise escalating doses (0.25 mg/kg/week, 0.48 mg/kg/week and 0.66 mg/kg/week), each for two weeks sequentially. For the remaining 46 weeks, patients will continue to receive MOD-4023 at a dose of 0.66 mg/kg/week.
Control intervention name : Genotropin
INN of the control intervention : somatropin
Dosage And administration of the control intervention : Daily SC injections Genotropin (0.025 mg/kg/day).
OPKO Health Inc.(ICCC: EPS International Holdings Co., Ltd)NULLcomplete311BOTH44Phase 3Japan
7EUCTR2016-003874-42-ES
(EUCTR)
18/05/201714/03/2017An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiencyA phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A Growth hormone deficiency in pre-pubertal children
MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: MOD-4023
INN or Proposed INN: Somatrogon
Product Code: MOD-4023
INN or Proposed INN: Somatrogon
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
Trade Name: Genotropin
Product Name: Genotropin
INN or Proposed INN: Somatropin
Other descriptive name: SOMATROPIN FOR INJECTION
OPKO Biologics Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
220Phase 3Serbia;Belarus;United States;Taiwan;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Vietnam;India;France;Australia;Netherlands;Turkey;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Germany;New Zealand