potassium bitartrate
Approved
May 22, 2020
Potassium bitartrate, also known as potassium hydrogen tartrate, with formula KC4H5O6, is the potassium acid salt of tartaric acid (a carboxylic acid)—specifically, l-( + )-tartaric acid. Especially in cooking, it is also known as cream of tartar. Tartaric acid and potassium naturally occur in grapes, and potassium bitartrate is produced as a byproduct of winemaking by purifying the precipitate deposited by fermenting must in wine barrels. — Wikipedia
Clinical trial activity
3 trials · 6 clinical orgs · 1 marketing orgs
Earliest trial started May 1, 2009 (NCT00910832)
Timeline
1800s
- Jan 1, 1800
Evidence of US Marketing
2010s
- Jan 1, 2017
Evofem Inc. — Earliest Phase 3 Sponsor(trial)
2020s
- May 22, 2020
Evofem Inc. — Earliest FDA Approval
- May 22, 2020
Evofem Inc. — NDA Secondary Org
- May 22, 2020
Evofem Inc. — NDA Organization
Indications
Approved for
Studied for
Mechanism of action
- carbon dioxideRELEASING AGENT
carbon dioxide releasing agent
Combination products
phexxi
with lactic acid, citric acid
Approval history
- approvedMay 22, 2020
- approvedJan 1, 1800
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaPotassium bitartrate ↗
Also known as
- eductyl
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT03243305 | Phase 3 | Jul 27, 2017 | Evofem Inc., Parexel |
| NCT01243723 | Phase 4 | Nov 1, 2010 | Laboratoires Techni Pharma, Nukleus, Suresnes Hospital |
| NCT00910832 | Phase 4 | May 1, 2009 | Diaconesses hospital, Laboratoires Techni Pharma |
Organizations
Research & Development (6)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Laboratoires Techni Pharma | For profit | 2 | 2 | 1 | 2009 |
| Diaconesses hospital | Academic/Hospital | 1 | 0 | 1 | 2009 |
| Evofem Inc. | For profit | 1 | 1 | 1 | 2017 |
| Nukleus | For profit | 1 | 0 | 1 | 2010 |
| Parexel | For profit | 1 | 0 | 1 | 2017 |
| Suresnes Hospital | Academic/Hospital | 1 | 0 | 1 | 2010 |
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Evofem Inc. | For profit | NDA2 | May 22, 2020 |
| Evofem Inc. | For profit | NDA | May 22, 2020 |