Somapacitan

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

Title	Posted	Study ID	Phase	Status	Sponsor
A Study to Follow Paediatric Participants With Growth Hormone Deficiency Treated With Somapacitan for Long Term Safety Information and Clinical Parameters	2024/11/29	NCT06709040	N/A	ENROLLING_BY_INVITATION	Novo Nordisk A/S
Special Use-results Surveillance on Long Term Use of Sogroya® in Children With Short Stature Due to Growth Hormone Deficiency Where Epiphysial Discs Are Not Closed	2023/10/31	NCT06109935	N/A	ENROLLING_BY_INVITATION	Novo Nordisk A/S
A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9	2023/02/13	NCT05723835	Phase 3	Active, not recruiting	Novo Nordisk A/S
A Study to Follow Patients With Adult Growth Hormone Deficiency (AGHD) Treated With Sogroya® for Long Term Safety Information	2023/02/08	NCT05718570	N/A	ENROLLING_BY_INVITATION	Novo Nordisk A/S
A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow	2022/04/15	NCT05330325	Phase 3	Active, not recruiting	Novo Nordisk A/S
Post-Marketing Surveillance (Special Use-results Surveillance on Long-term Use) With Sogroya®	2022/02/09	NCT05230550	N/A	ENROLLING_BY_INVITATION	Novo Nordisk A/S
A Research Study in Chinese Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day.	2021/07/21	NCT04970654	Phase 3	Completed	Novo Nordisk A/S
A Study to Compare the Uptake Into the Blood of Two Strengths of Somapacitan After Injection Under the Skin in Healthy Subjects	2019/04/05	NCT03905850	Phase 1	Completed	Novo Nordisk A/S
A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day	2019/03/18	NCT03878446	Phase 2	Active, not recruiting	Novo Nordisk A/S
A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4)	2019/01/22	NCT03811535	Phase 3	Active, not recruiting	Novo Nordisk A/S

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
SOGROYA	Novo Nordisk	0169-2035	SUBCUTANEOUS	3.3 mg in 1 mL	4/28/2023
SOGROYA	Novo Nordisk	0169-2030	SUBCUTANEOUS	6.7 mg in 1 mL	4/28/2023
SOGROYA	Novo Nordisk	0169-2037	SUBCUTANEOUS	10 mg in 1 mL	4/28/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Sogroya	Novo Nordisk A/S,Novo Allé,DK-2880 Bagsvaerd,Denmark	Authorised	3/31/2021

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
SOGROYA SOLUTION FOR INJECTION IN PRE-FILLED PEN 15MG/1.5ML	Novo Nordisk A/S (Formulation, Filling and Primary packager)	SIN17218P	INJECTION, SOLUTION	15mg/1.5ml	4/14/2025
SOGROYA SOLUTION FOR INJECTION IN PRE-FILLED PEN 10MG/1.5ML	Novo Nordisk A/S (Formulation, Filling and Primary packager)	SIN17217P	INJECTION, SOLUTION	10mg/1.5ml	4/14/2025
SOGROYA SOLUTION FOR INJECTION IN PRE-FILLED PEN 5MG/1.5ML	Novo Nordisk A/S (Formulation, Filling and Primary packager)	SIN17216P	INJECTION, SOLUTION	5mg/1.5ml	4/14/2025

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
SOGROYA SOLUTION FOR INJECTION IN PRE-FILLED PEN 10MG/1.5ML	N/A	novo nordisk hong kong ltd.	N/A	N/A	9/9/2024
SOGROYA SOLUTION FOR INJECTION IN PRE-FILLED PEN 5MG/1.5ML	N/A	novo nordisk hong kong ltd.	N/A	N/A	9/9/2024
SOGROYA SOLUTION FOR INJECTION IN PRE-FILLED PEN 15MG/1.5ML	N/A	novo nordisk hong kong ltd.	N/A	N/A	9/9/2024

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
SOGROYA somapacitan 5 mg (3.3 mg/mL) solution for injection prefilled pen	396877	Novo Nordisk Pharmaceuticals Pty Ltd	Medicine	A	9/18/2023
SOGROYA somapacitan 15 mg (10 mg/mL) solution for injection prefilled pen	396878	Novo Nordisk Pharmaceuticals Pty Ltd	Medicine	A	9/18/2023
SOGROYA somapacitan 10 mg (6.7 mg/mL) solution for injection prefilled pen	363895	Novo Nordisk Pharmaceuticals Pty Ltd	Medicine	A	2/21/2022

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
SOGROYA	Novo Nordisk Canada Inc	02539942	Solution - Subcutaneous	10 MG / 1.5 ML	11/27/2023
SOGROYA	Novo Nordisk Canada Inc	02539934	Solution - Subcutaneous	5 MG / 1.5 ML	11/27/2023
SOGROYA	Novo Nordisk Canada Inc	02539950	Solution - Subcutaneous	15 MG / 1.5 ML	11/27/2023

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
SOGROYA 15 MG/1,5 ML SOLUCION INYECTABLE EN PLUMA PRECARGADA	Novo Nordisk A/S	1201501005	SOLUCIÓN INYECTABLE	Uso Hospitalario	Not Commercialized
SOGROYA 5 MG/1,5 ML SOLUCION INYECTABLE EN PLUMA PRECARGADA	Novo Nordisk A/S	1201501003	SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA	Uso Hospitalario	Not Commercialized
SOGROYA 10 MG/1,5 ML SOLUCION INYECTABLE EN PLUMA PRECARGADA	Novo Nordisk A/S	1201501001	SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA	Uso Hospitalario	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

Novo Nordisk's Once-Weekly Sogroya Shows Efficacy in Children with Growth Disorders in Phase 3 Trial

3 months ago

The REAL8 phase 3 trial demonstrated that once-weekly Sogroya (somapacitan) was non-inferior to daily growth hormone in children with growth disorders, with superior results in Noonan syndrome patients.

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