Drugs / Ulipristal acetate (UPA)
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT02147158 | Jan 2014 → Nov 2016 | leiomyoma, uterine disorder | Allergan | Completed | Met primary |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2018-08-21 | AbbVie | Regulatory Allergan Receives Complete Response Letter from the U.S. Food and Drug Administration for Ulipristal Acetate New Drug Application abbvie.com ↗
The letter from the FDA indicates it is not able to approve the ulipristal acetate NDA in its current form and is requesting additional information. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2018-08-21 | AbbVie | Allergan Receives Complete Response Letter from the U.S. Food and Drug Administration for Ulipristal Acetate New Drug Application abbvie.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ulipristal acetate (UPA) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02147158 ↗ |
| Known as | UPA | “Ulipristal acetate (UPA) tablet.” NCT02147158 ↗ |
| Route | Oral | “UPA 5 mg tablet plus matching placebo 10 mg tablet, orally” NCT02147158 ↗ |