Fosdenopterin
Trade name: Nulibry
Approved
Feb 26, 2021
CPMP may refer to:Committee for Proprietary Medicinal Products Certified Project Management Professional Core-Plus Mathematics Project Cyclic pyranopterin monophosphate or fosdenopterin Commissioning Process Management Professional (ASHRAE) — Wikipedia
Clinical trial activity
4 trials · 4 clinical orgs · 3 marketing orgs
Earliest trial started Aug 1, 2009 (NCT00957749)
Timeline
2000s
- Jan 1, 2009
Earliest Phase 1 Sponsor(trial)
- Nov 5, 2009
Orphan Drug Designation
2010s
- Jan 1, 2014
Earliest Phase 2 Sponsor(trial)
2020s
- Feb 26, 2021
Zydus Discovery DMCC — Earliest FDA Approval
- Feb 26, 2021
Sentynl Theraps Inc — Marketing Organization
- Feb 26, 2021
Bridge Biotherapeutics, Inc. — Marketing Organization
- Feb 26, 2021
Zydus Discovery DMCC — NDA Secondary Org
- Feb 26, 2021
Zydus Discovery DMCC — NDA Organization
Indications
Mechanism of action
- Unspecified targetOTHER
Unknown
Substrate replacement therapy (exogenous source of cPMP)
Approval history
- approvedPriority reviewBreakthroughFeb 26, 2021
Chemistry & pharmacology
SMILES
Nc1nc(=O)c2c([nH]1)N[C@@H]1O[C@@H]3COP(=O)(O)O[C@@H]3C(O)(O)[C@@H]1N2- Mol. weight
- 363.22 g/mol
- Lipinski Ro5
- 2 violation(s)
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaCPMP ↗
- ChEMBLCHEMBL4594300 ↗
- ChEMBLCHEMBL2338675 ↗
Also known as
- alxn1101
- cpmp
- cpmp
- cyclic pyranopterin monophosphate
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT02629393 | Phase 2/Phase 3 (Phase 3) | May 1, 2016 | Alexion |
| NCT02047461 | Phase 2 | Apr 1, 2014 | Alexion |
| NCT01894165 | Phase 1 | Jun 1, 2013 | Alexion, Parexel |
| NCT00957749 | Phase 1/Phase 2 (Phase 2) | Aug 1, 2009 | Monash University, Orphatech Pharmaceuticals, GmbH |
Organizations
Research & Development (4)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Alexion | For profit | 3 | 3 | 3 | 2013 |
| Monash University | Academic/Hospital | 1 | 0 | 1 | 2009 |
| Orphatech Pharmaceuticals, GmbH | For profit | 1 | 1 | 1 | 2009 |
| Parexel | For profit | 1 | 0 | 1 | 2013 |
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Bridge Biotherapeutics, Inc. | For profit | MKTG | Feb 26, 2021 |
| Sentynl Theraps Inc | For profit | MKTG | Feb 26, 2021 |
| Zydus Discovery DMCC | For profit | NDA2 | Feb 26, 2021 |
| Zydus Discovery DMCC | For profit | NDA | Feb 26, 2021 |