Drugs / Carglumic Acid
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | CARBAGLU | — | 2021-01-22 | fda.gov ↗ |
| Approved | US (FDA) | CARBAGLU | — | 2010-03-18 | fda.gov ↗ |
| Approved | EU (EMA) | Carbaglu | — | 2003-01-24 | europa.eu ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT01599286 | Sep 2012 → Apr 2019 | carbamoyl phosphate synthetase I deficiency disease, methylmalonic acidemia, ornithine carbamoyltransferase deficiency, propionic acidemia | Mendel Tuchman | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT02426775 | Nov 2015 → Mar 2019 | methylmalonic acidemia, propionic acidemia | King Abdullah International Medical Research Center | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT04284917 | Nov 2019 → Dec 2024 | inborn organic aciduria | National Taiwan University Hospital | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2021-01-26 | RECORDATI GROUP | Regulatory RECORDATI: CARBAGLU receives U.S. FDA Approval for a New Indication to Treat Acute Hyperammonemia Associated with Propionic Acidemia and Methylmalonic Acidemia recordati.com ↗
Recordati, through its US subsidiary Recordati Rare Diseases Inc. , today announced the U.S. Food and Drug Administration (FDA) has approved a new indication for CARBAGLU® (carglumic acid) tablets 200mg as adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to propionic acidemia (PA) or methylmalonic acidemia (MMA) in pediatric and adult patients. |
| 2015-09-08 | RECORDATI GROUP | Regulatory ORPHAN EUROPE Announces that Health Canada has Granted Market Authorization for Carbaglu® (carglumic acid), recordati.com ↗ |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2021-01-26 | RECORDATI GROUP | RECORDATI: CARBAGLU receives U.S. FDA Approval for a New Indication to Treat Acute Hyperammonemia Associated with Propionic Acidemia and Methylmalonic Acidemia recordati.com ↗ |
| 2015-09-08 | RECORDATI GROUP | ORPHAN EUROPE Announces that Health Canada has Granted Market Authorization for Carbaglu® (carglumic acid), recordati.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Carglumic Acid | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02426775 ↗ |
| Known as | Carbaglu | “Carglumic Acid (Carbaglu®)” NCT04284917 ↗ |
| Route | Oral | “administered orally or enterally by nasogastric or gastrostomy tube” NCT01599286 ↗ |
| Route | Other | “administered orally or enterally by nasogastric or gastrostomy tube” NCT01599286 ↗ |