Somapacitan
- Generic Name
- Somapacitan
- Brand Names
- Sogroya
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 1338578-34-9
- Unique Ingredient Identifier
- 8FOJ430U94
- Background
Somapacitan, also known as NNC0195-0092, is a growth hormone analog indicated to treat adults with growth hormone deficiency. This human growth hormone analog differs by the creation of an albumin binding site, and prolonging the effect so that it requires weekly dosing rather than daily.
Somapacitan was granted FDA approval on 28 August 2020.
- Indication
Somapacitan is indicated as a replacement for growth hormone in adult patients with growth hormone deficiency.
- Associated Conditions
- Human Growth Hormone Deficiency
- Associated Therapies
- Growth Hormone Therapy
Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Mild and Moderate Degrees of Hepatic Impairment Compared to Subjects With Normal Hepatic Function.
- Conditions
- Interventions
- First Posted Date
- 2017-07-11
- Last Posted Date
- 2019-05-24
- Lead Sponsor
- Novo Nordisk A/S
- Target Recruit Count
- 34
- Registration Number
- NCT03212131
- Locations
- 🇸🇰
Novo Nordisk Investigational Site, Bratislava, Slovakia
Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function
- Conditions
- Interventions
- First Posted Date
- 2017-06-14
- Last Posted Date
- 2020-04-17
- Lead Sponsor
- Novo Nordisk A/S
- Target Recruit Count
- 44
- Registration Number
- NCT03186495
- Locations
- 🇩🇪
Novo Nordisk Investigational Site, Berlin, Germany
A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency
- Conditions
- Interventions
- First Posted Date
- 2017-03-09
- Last Posted Date
- 2020-11-23
- Lead Sponsor
- Novo Nordisk A/S
- Target Recruit Count
- 62
- Registration Number
- NCT03075644
- Locations
- 🇯🇵
Novo Nordisk Investigational Site, Yokohama, Kanagawa, Japan
A Trial Investigating the Absorption, Metabolism and Excretion of Somapacitan After Single Dosing in Healthy Male Subjects
- First Posted Date
- 2016-11-11
- Last Posted Date
- 2017-06-07
- Lead Sponsor
- Novo Nordisk A/S
- Target Recruit Count
- 7
- Registration Number
- NCT02962440
- Locations
- 🇳🇱
Novo Nordisk Investigational Site, Groningen, Netherlands
Investigating Efficacy and Safety of Once-weekly NNC0195-0092 (Somapacitan) Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency
- Conditions
- Interventions
- First Posted Date
- 2015-11-30
- Last Posted Date
- 2024-11-26
- Lead Sponsor
- Novo Nordisk A/S
- Target Recruit Count
- 74
- Registration Number
- NCT02616562
- Locations
- 🇯🇵
Institute of Science Tokyo Hospital, Tokyo, Japan
🇺🇸Nemours/AI duPont Hosp-Chld, Wilmington, Delaware, United States
🇺🇸Goryeb Children's Hospital, Morristown, New Jersey, United States
A Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Previously Human Growth Hormone Treated Adults With Growth Hormone Deficiency
- Conditions
- Interventions
- First Posted Date
- 2015-03-09
- Last Posted Date
- 2020-07-09
- Lead Sponsor
- Novo Nordisk A/S
- Target Recruit Count
- 92
- Registration Number
- NCT02382939
- Locations
- 🇬🇧
Novo Nordisk Investigational Site, Manchester, United Kingdom
Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.
- Conditions
- Interventions
- First Posted Date
- 2014-09-03
- Last Posted Date
- 2020-11-23
- Lead Sponsor
- Novo Nordisk A/S
- Target Recruit Count
- 301
- Registration Number
- NCT02229851
- Locations
- 🇬🇧
Novo Nordisk Investigational Site, Manchester, United Kingdom
A Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency
- Conditions
- Interventions
- First Posted Date
- 2013-10-31
- Last Posted Date
- 2020-12-24
- Lead Sponsor
- Novo Nordisk A/S
- Target Recruit Count
- 32
- Registration Number
- NCT01973244
- Locations
- 🇨🇭
Novo Nordisk Investigational Site, Genève, Switzerland
A Trial Investigating the Safety, Tolerability, Availability and Distribution in the Body of Once-weekly Long-acting Growth Hormone (Somapacitan) Compared to Once Daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency
- Conditions
- Interventions
- First Posted Date
- 2012-10-15
- Last Posted Date
- 2020-12-24
- Lead Sponsor
- Novo Nordisk A/S
- Target Recruit Count
- 35
- Registration Number
- NCT01706783
- Locations
- 🇸🇪
Novo Nordisk Investigational Site, Stockholm, Sweden
First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects
- Conditions
- Interventions
- First Posted Date
- 2012-01-23
- Last Posted Date
- 2020-12-24
- Lead Sponsor
- Novo Nordisk A/S
- Target Recruit Count
- 105
- Registration Number
- NCT01514500
- Locations
- 🇩🇪
Novo Nordisk Investigational Site, Neuss, Germany
Drug Development Updates
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