Macimorelin
As of the edition of 20 October 2026, Macimorelin is a small molecule: marketed, first approved in 2017 (US); acts on GHSR; US protection ends in 2030.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2019
- Kind
- Small molecule
- Brand name
- Macrilen
- First approved
- 20 December 2017 (US)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Atnahs Pharma; 2 holders in all
- Registered trials
- 2, 0 stopped early
- Disease areas
- Bones, joints and muscles; Hormones; Nervous system
US protection
US protection ends in 2030.
The last listed US exclusivity ends in 2030. The application that gives this date is held by COSCIENS Biopharma.
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 product2 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
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Macimorelin.
See the 2 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| GHSR | Growth hormone secretagogue receptor type 1 | Q92847 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 3 | 2 | 2 | 0 | 0 |
| All trials | 2 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| COSCIENS Biopharma | Originator and Lead sponsor of trials | 2007 to now |
| Atnahs Pharma | Applicant | 2019 to now |