Drugs / 4-Phenylbutyrate
4-Phenylbutyrate
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2/3 | NCT04531878 | Feb 2023 | intrahepatic cholestasis | Children's Hospital of Fudan University | Withdrawn | No outcome recorded Stop: Business |
Press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2019-11-19 | Immedica Pharma AB | Immedica starts to distribute Ravicti[®] and Ammonaps[®] in Europe and the Middle East from 1 January 2020 immedica.com ↗ |
| 2019-07-02 | Immedica Pharma AB | Immedica Pharma becomes market authorisation holder for Ammonaps® and Ravicti® in Europe immedica.com ↗ |
| 2016-12-07 | Sobi, Inc. | Sobi and Horizon Pharma enter five-year distribution agreement for Ravicti® and Ammonaps® outside the United States sobi.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | 4-Phenylbutyrate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04531878 ↗ |
| Known as | AMMONAPS | “4-phenylbutyrate therapy will be started at a daily dose of 200 mg kg/d divided in 2 oral doses of sodium phenylbutyrate (AMMONAPS, Swedish Orphan Inter AB).” NCT04531878 ↗ |
| Known as | sodium phenylbutyrate | “4-phenylbutyrate therapy will be started at a daily dose of 200 mg kg/d divided in 2 oral doses of sodium phenylbutyrate (AMMONAPS, Swedish Orphan Inter AB).” NCT04531878 ↗ |
| Route | Oral | “2 oral doses of sodium phenylbutyrate” NCT04531878 ↗ |