Product Description
Somapacitan is a long-acting, reversible albumin-binding GH derivative in development for once-weekly administration in patients with growth hormone deficiency (GHD). (Sourced from: https://pubmed.ncbi.nlm.nih.gov/31917835/)
Mechanisms of Action: Growth Hormone Analogue
Novel Mechanism: No
Modality: Peptide/Protein
Route of Administration: Subcutaneous
FDA Designation: None *
Approval Status: Approved
Approved Countries: Australia | Belgium | Croatia | Czech | Denmark | Estonia | European Medicines Agency | Finland | Germany | Greece | Hungary | Iceland | Ireland | Italy | Japan | Latvia | Lithuania | Netherlands | Poland | Portugal | Romania | Saudi Arabia | Slovakia | Slovenia | Sweden | Taiwan | United States
Approved Indications: None
Known Adverse Events: None
Company: Novo Nordisk
Company Location: BAGSVAERD DENMARK G7 00000
Company CEO: Lars Fruergaard Jorgensen
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Algeria, Austria, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Estonia, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Saudi Arabia, Serbia, Slovenia, South Africa, Spain, Switzerland, Thailand, Ukraine, United Kingdom, United States
Active Clinical Trial Count: 15
Highest Development Phases
Phase 3: Dwarfism, Pituitary|Gonadal Dysgenesis|Hypopituitarism|Noonan Syndrome|Turner Syndrome
Phase 2: Dwarfism|Other
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| NN8640-4467 | P3 |
Unknown Status |
Noonan Syndrome|Turner Syndrome |
2027-06-16 |
|
| NN8640-4469 | P3 |
Unknown Status |
Turner Syndrome|Noonan Syndrome |
2027-03-18 |
|
| 2021-005607-13 | P3 |
Active, not recruiting |
Noonan Syndrome|Turner Syndrome |
2026-07-09 |
|
| NN8640-4263 | P3 |
Unknown Status |
Hypopituitarism |
2025-09-30 |