Pregnanolone clinical trials
Also written UC1010.
- studies test it
- 4
- open now
- 0
- in phase 3
- 0
- first study started
- 2013
How each study uses Pregnanolone is sorted by a rule, right about nine times in ten. Readers can ask us to read every study one by one.Ask us to read each study
Approvals
The first approval found in each region, with its record
- United States
- 19 Mar 2019 · ZULRESSO · NDA 211371 (FDA, Drugs@FDA)
- European Union
- Not in EMA's list of EU-wide authorisations
From FDA's Drugs@FDA and Purple Book (through openFDA) and the European Medicines Agency, files of Sept 2026 and 27 Oct 2026. National approvals in Europe and other countries are not included. How this is worked out
How studies write it
Studies that test it under each name
Studies by the year they started
4 studies that test it; most in 2013 (1)
| Year | Studies |
|---|---|
| 2013 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2022 | 1 |
By phase
A phase 1/2 study counts in both.
What it is tested for
Each study’s main condition, where its own words name it, so a study counts once.
Who runs them
Industry 4 · Other 0
Studies
Open first, then newest update. How each study uses Pregnanolone is read from its arms, and is right about nine times in ten. Ask us to read each study. These are the studies that list it as an intervention; a search of ClinicalTrials.gov also finds studies that mention it only in a description, such as earlier treatment.
Testing it · 4
- A Study to Explore the Effect of Sepranolone in Tourette SyndromeCompletedPhase 2Asarina PharmaNCT05434546Written as Sepranolone
- A Study Investigating the Efficacy and Safety of Sepranolone in Women With Menstrual MigraineCompletedPhase 2Asarina PharmaNCT04102995Written as Sepranolone injection low dose
- A Study of Efficacy and Safety of Sepranolone (UC1010) in Patients With Premenstrual Dysphoric Disorder (PMDD)CompletedPhase 2Asarina PharmaNCT03697265Written as Sepranolone (UC1010) low dose
- A Phase I/II Study to Evaluate UC1010 Treatment in Premenstrual Dysphoric Disorder (PMDD)CompletedPhase 1/2Umecrine Mood ABNCT01875718Written as UC1010
Codes
What other systems call Pregnanolone · ClinicalTrials.gg INT008085
- MeSH (NLM) D011280PregnanoloneConfirmed ClinicalTrials.gov, NLM, Wikidata
- UNII (FDA) BXO86P3XXWELTANOLONEConfirmed FDA, NLM, Wikidata
- Wikidata Q18344323pregnanoloneConfirmed FDA, NLM, Wikidata
- DrugBank DB12308One source Wikidata
| System | Code | Name there | Checked by |
|---|---|---|---|
| MeSH (NLM) | D011280 | Pregnanolone | Confirmed ClinicalTrials.gov, NLM, Wikidata |
| UNII (FDA) | BXO86P3XXW | ELTANOLONE | Confirmed FDA, NLM, Wikidata |
| Wikidata | Q18344323 | pregnanolone | Confirmed FDA, NLM, Wikidata |
| DrugBank | DB12308 | — | One source Wikidata |
Also registered as brexanolone (UNII S39XZ5QV8Y · RxNorm 2121777) and sepranolone (UNII 3P8Z6V53MU).
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.