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Somapacitan

Generic Name
Somapacitan
Brand Names
Sogroya
Drug Type
Biotech
CAS Number
1338578-34-9
Unique Ingredient Identifier
8FOJ430U94

Overview

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

Clinical Trials

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Title
Posted
Study ID
Phase
Status
Sponsor
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.
2017/07/11
NCT03212131
Phase 1
Completed
Novo Nordisk A/S
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
2017/06/14
NCT03186495
Phase 1
Completed
Novo Nordisk A/S
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
2017/03/09
NCT03075644
Phase 3
Completed
Novo Nordisk A/S
A Trial Investigating the Absorption, Metabolism and Excretion of Somapacitan After Single Dosing in Healthy Male Subjects
2016/11/11
NCT02962440
Phase 1
Completed
Novo Nordisk A/S
Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency
2015/11/30
NCT02616562
Phase 2
Completed
Novo Nordisk A/S
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
2015/03/09
NCT02382939
Phase 3
Completed
Novo Nordisk A/S
Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.
2014/09/03
NCT02229851
Phase 3
Completed
Novo Nordisk A/S
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
2013/10/31
NCT01973244
Phase 1
Completed
Novo Nordisk A/S
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
2012/10/15
NCT01706783
Phase 1
Completed
Novo Nordisk A/S
First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects
2012/01/23
NCT01514500
Phase 1
Completed
Novo Nordisk A/S

FDA Drug Approvals

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NMPA Drug Approvals

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Health Canada Drug Approvals

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UK EMC Drug Information

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