Prasterone
As of the edition of 20 October 2026, Prasterone is a small molecule: marketed, first approved in 2016 (US); no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2018
- Kind
- Small molecule
- Brand name
- Intrarosa
- First approved
- 16 November 2016 (US)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- EndoCeutics; 2 holders in all
- Withdrawn from market
- 1 January 1985 (in some regions)
- Registered trials
- 61, 8 stopped early
- Disease areas
- Urinary and reproductive; Skin and connective tissue; Pregnancy and women's health; Immune system; Bones, joints and muscles; Cancer
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 8 | 7 | 0 | 0 |
| Phase 1 | 8 | 4 | 0 | 4 |
| Phase 2 | 13 | 10 | 1 | 2 |
| Phase 3 | 28 | 22 | 1 | 2 |
| Phase 4 | 4 | 4 | 0 | 0 |
| All trials | 61 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| EndoCeutics | Originator, Applicant and Lead sponsor of trials | 2007 to now |
| Millicent Pharma | Acquired holder | 2020 to now |