Vamorolone
As of the edition of 20 October 2026, Vamorolone is a small molecule: marketed, first approved in 2023 (US); acts on NR3C1 and NR3C2; US protection ends in 2040.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2023
- Kind
- Small molecule
- Brand name
- Agamree
- First approved
- 26 October 2023 (US)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Santhera Pharmaceuticals; 2 holders in all
- Registered trials
- 13, 1 stopped early
- Disease areas
- Bones, joints and muscles; Inherited and neonatal; Nervous system
US protection
US protection ends in 2040.
The last listed US drug-substance patent ends in 2040. The application that gives this date is held by Angelini Pharma.
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 product4 listings count 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
4 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product4 company-target rows are on route B because of Vamorolone.
See the 4 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 0 | 1 | 0 |
| Phase 1 | 3 | 3 | 0 | 0 |
| Phase 2 | 7 | 6 | 0 | 1 |
| Phase 4 | 1 | 0 | 1 | 0 |
| All trials | 13 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Angelini Pharma | Originator and Lead sponsor of trials | 2023 to now |
| Santhera Pharmaceuticals | Applicant | 2023 to now |