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
A Study to Follow Paediatric Participants With Growth Hormone Deficiency Treated With Somapacitan for Long Term Safety Information and Clinical Parameters
- Conditions
- Interventions
- First Posted Date
- 2024-11-29
- Last Posted Date
- 2024-11-29
- Lead Sponsor
- Novo Nordisk A/S
- Target Recruit Count
- 500
- Registration Number
- NCT06709040
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
- Conditions
- Interventions
- First Posted Date
- 2023-10-31
- Last Posted Date
- 2024-08-20
- Lead Sponsor
- Novo Nordisk A/S
- Target Recruit Count
- 200
- Registration Number
- NCT06109935
- Locations
- 🇯🇵
Asahikawa Medical Univ. Hospital, Pediatrics, Asahikawa, Hokkaido, Japan
🇯🇵Beppu Medical Center, Beppu-shi, Oita-ken, Japan
🇯🇵Fukuoka University Hospital, Fukuoka-shi, Fukuoka-ken, Japan
A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9
- First Posted Date
- 2023-02-13
- Last Posted Date
- 2024-06-24
- Lead Sponsor
- Novo Nordisk A/S
- Target Recruit Count
- 48
- Registration Number
- NCT05723835
- Locations
- 🇺🇸
Rocky Mt Ped and Endo, Centennial, Colorado, United States
🇵🇱SPSK nr 1 im. prof.S.Szyszko w Zabrzu, Zabrze, Poland
🇺🇸Univ of AL at Birmingham_BRM, Birmingham, Alabama, United States
A Study to Follow Patients With Adult Growth Hormone Deficiency (AGHD) Treated With Sogroya® for Long Term Safety Information
- Conditions
- Interventions
- First Posted Date
- 2023-02-08
- Last Posted Date
- 2024-12-16
- Lead Sponsor
- Novo Nordisk A/S
- Target Recruit Count
- 400
- Registration Number
- NCT05718570
- Locations
- 🇺🇸
Washington University, Saint Louis, Missouri, United States
🇺🇸Barrow Neurological Institute, Phoenix, Arizona, United States
🇺🇸Keck Medical Center of USC - Outpatient Clinic, Los Angeles, California, United States
A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow
- Conditions
- Interventions
- First Posted Date
- 2022-04-15
- Last Posted Date
- 2024-10-17
- Lead Sponsor
- Novo Nordisk A/S
- Target Recruit Count
- 399
- Registration Number
- NCT05330325
- Locations
- 🇵🇱
Klinika Endokrynologii i Chorób Metabolicznych, Lodz, Poland
🇸🇮University Children's Hospital, Ljubljana, Slovenia
🇺🇸Univ of AL at Birmingham_BRM, Birmingham, Alabama, United States
Post-Marketing Surveillance (Special Use-results Surveillance on Long-term Use) With Sogroya®
- Conditions
- Interventions
- First Posted Date
- 2022-02-09
- Last Posted Date
- 2023-11-27
- Lead Sponsor
- Novo Nordisk A/S
- Target Recruit Count
- 200
- Registration Number
- NCT05230550
- Locations
- 🇯🇵
Novo Nordisk Investigational Site, Tokyo, Japan
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.
- Conditions
- Interventions
- First Posted Date
- 2021-07-21
- Last Posted Date
- 2024-12-10
- Lead Sponsor
- Novo Nordisk A/S
- Target Recruit Count
- 110
- Registration Number
- NCT04970654
- Locations
- 🇨🇳
Hunan Children's Hospital, Changsha, Hunan, China
🇨🇳Jiangxi Provincial Children's Hospital, Nanchang, Jiangxi, China
🇨🇳The Second Hospital of Anhui Medical University, Hefei, Anhui, China
A Study to Compare the Uptake Into the Blood of Two Strengths of Somapacitan After Injection Under the Skin in Healthy Subjects
- First Posted Date
- 2019-04-05
- Last Posted Date
- 2019-08-06
- Lead Sponsor
- Novo Nordisk A/S
- Target Recruit Count
- 33
- Registration Number
- NCT03905850
- Locations
- 🇩🇪
Novo Nordisk Investigational Site, Neuss, Germany
A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day
- Conditions
- Interventions
- First Posted Date
- 2019-03-18
- Last Posted Date
- 2024-12-16
- Lead Sponsor
- Novo Nordisk A/S
- Target Recruit Count
- 62
- Registration Number
- NCT03878446
- Locations
- 🇯🇵
Institute of Science Tokyo Hospital, Tokyo, Japan
🇺🇸Univ of AL at Birmingham_BRM, Birmingham, Alabama, United States
🇺🇸Goryeb Children's Hospital, Morristown, New Jersey, United States
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)
- Conditions
- Interventions
- First Posted Date
- 2019-01-22
- Last Posted Date
- 2024-11-27
- Lead Sponsor
- Novo Nordisk A/S
- Target Recruit Count
- 200
- Registration Number
- NCT03811535
- Locations
- 🇸🇮
University Children's Hospital, Ljubljana, Slovenia
🇺🇸Univ of AL at Birmingham_BRM, Birmingham, Alabama, United States
🇺🇸Children's Hospital Los Angeles - Endocrinology, Los Angeles, California, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.