Somapacitan
As of the edition of 20 October 2026, Somapacitan is a small molecule: marketed, first approved in 2020 (US); acts on GHR; US protection ends in 2032.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2024
- Kind
- Small molecule
- Brand name
- Sogroya
- First approved
- 28 August 2020 (US)
- Approvals on record
- 9 in 5 regions
- Holder of the most recent approval
- Novo Nordisk; 3 holders in all
- Registered trials
- 20, 0 stopped early
- Disease areas
- Bones, joints and muscles; Hormones; Nervous system; Heart and blood vessels; Inherited and neonatal; Pregnancy and women's health
US protection
US protection ends in 2032.
US protection ends in 2032, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Novo Nordisk. The date is computed, not published.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product1 listing counts towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Somapacitan.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| GHR | Growth hormone receptor | P10912 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 4 | 0 | 4 | 0 |
| Phase 1 | 7 | 7 | 0 | 0 |
| Phase 2 | 2 | 1 | 1 | 0 |
| Phase 3 | 7 | 5 | 2 | 0 |
| All trials | 20 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novo Nordisk | Originator, Applicant and Lead sponsor of trials | 2012 to now |