Drugs / ORGN001
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | fosdenopterin | sulfite oxidase deficiency due to molybdenum cofactor deficiency type B2 | 2020-09-29 | “today announced the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for fosdenopterin” bridgebio.com ↗ |
| Filed | US (FDA) | fosdenopterin | sulfite oxidase deficiency due to molybdenum cofactor deficiency type B2 | 2019-12-03 | “has initiated a rolling submission of a New Drug Application (NDA) with the United States Food and Drug Administration (FDA) for fosdenopterin” bridgebio.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT02047461 | Apr 2014 → Aug 2022 | sulfite oxidase deficiency due to molybdenum cofactor deficiency type A | Origin Biosciences | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02629393 | May 2016 → Sep 2022 | sulfite oxidase deficiency due to molybdenum cofactor deficiency type A | Origin Biosciences | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2020-09-29 | Eidos Therapeutics, a BridgeBio company | Regulatory bridgebio pharma and affiliate origin biosciences announces fda acceptance of its new drug application for fosdenopterin for the treatment of mocd type a bridgebio.com ↗
BridgeBio Pharma, Inc. (Nasdaq: BBIO) and affiliate Origin Biosciences today announced the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for fosdenopterin (previously BBP-870/ORGN001), a cyclic pyranopterin monophosphate (cPMP) substrate replacement therapy, for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A. |
| 2019-12-03 | Eidos Therapeutics, a BridgeBio company | Regulatory bridgebio pharma’s origin biosciences initiates rolling submission of new drug application with the u.s. fda for bbp-870 for the treatment of mocd type a bridgebio.com ↗
BridgeBio Pharma, Inc. (Nasdaq: BBIO) subsidiary Origin Biosciences has initiated a rolling submission of a New Drug Application (NDA) with the United States Food and Drug Administration (FDA) for fosdenopterin (BBP-870/ORGN001) for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2020-09-29 | Eidos Therapeutics, a BridgeBio company | bridgebio pharma and affiliate origin biosciences announces fda acceptance of its new drug application for fosdenopterin for the treatment of mocd type a bridgebio.com ↗ |
| 2019-12-03 | Eidos Therapeutics, a BridgeBio company | bridgebio pharma’s origin biosciences initiates rolling submission of new drug application with the u.s. fda for bbp-870 for the treatment of mocd type a bridgebio.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ORGN001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02047461 ↗ |
| Known as | ALXN1101 | “ORGN001 (formerly ALXN1101)” NCT02047461 ↗1“ORGN001 (formerly ALXN1101)” NCT02629393 ↗ |
| Route | Intravenous | “Patients will receive daily IV infusions of ORGN001 (formerly ALXN1101)” NCT02047461 ↗ |