danicopan
Trade name: VOYDEYA
Small moleculeapprovedOrphan Drug FDABreakthrough Therapy FDA
Approved
Mar 29, 2024
Clinical trial activity
27 trials · 8 clinical orgs · 2 marketing orgs
Phase 1
15
Phase 2
11
Phase 3
3
Phase 4
0
Earliest trial started Feb 4, 2016 (NCT04889677)
Timeline
2010s
2020s
- Jan 1, 2020
- Mar 29, 2024
AstraZeneca — Earliest FDA Approval
- Mar 29, 2024
Alexion — Marketing Organization
- Mar 29, 2024
AstraZeneca — NDA Organization
Indications
Studied for
- COVID-19 · Phase 2
- Genetic Diseases, Inborn · Phase 3
- Geographic Atrophy · Phase 2
- Glomerulonephritis · Phase 2
- Glomerulonephritis, Membranoproliferative · Phase 2
- Healthy Volunteers · Phase 1
- Hemoglobinuria, Paroxysmal · Phase 3
- Hemolysis · Phase 3
- Immune System Diseases · Phase 2
- Kidney Diseases · Phase 2
- Liver Diseases · Phase 1
Mechanism of action
- Complement factor DINHIBITOR
CFD inhibitor
Approval history
- approvedBreakthroughMar 29, 2024
Chemistry & pharmacology
Loading structure…
SMILES
CC(=O)c1nn(CC(=O)N2C[C@H](F)C[C@H]2C(=O)Nc2cccc(Br)n2)c2ccc(-c3cnc(C)nc3)cc12- Mol. weight
- 580.42 g/mol
- Lipinski Ro5
- 1 violation(s)
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
First in class
Sources
- ChEMBLCHEMBL4250860 ↗
Also known as
- ach-0144471
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06449001 | Phase 3 | Jan 15, 2025 | Alexion |
| NCT05708573 | Phase 1 | Feb 1, 2023 | Alexion |
| NCT05389449 | Phase 3 | Nov 1, 2022 | Alexion |
| NCT05019521 | Phase 2 | Aug 31, 2021 | Alexion |
| NCT04988035 | Phase 2 | Jul 21, 2021 | National Institute of Allergy and Infectious Diseases (NIAID) |
| NCT04469465 | Phase 3 | Dec 31, 2020 | Alexion |
| NCT04609696 | Phase 1 | Oct 31, 2020 | Alexion, Celerion |
| NCT04451434 | Phase 1 | Aug 31, 2020 | Alexion |
| NCT04551599 | Phase 1 | Feb 21, 2020 | Alexion, Celerion |
| NCT04709094 | Phase 1 | Jul 28, 2019 | Alexion, Celerion |
| NCT05109390 | Phase 1 | Jul 27, 2018 | Alexion |
| NCT05016206 | Phase 1 | Jul 26, 2018 | Alexion |
| NCT03459443 | Phase 2 | Jun 20, 2018 | Achillion Pharmaceuticals |
| NCT03369236 | Phase 2 | Jun 12, 2018 | Achillion Pharmaceuticals |
| NCT03555539 | Phase 1 | May 15, 2018 | Achillion Pharmaceuticals, Orlando Clinical Research Center, University of Miami |
| NCT03472885 | Phase 2 | May 8, 2018 | Achillion Pharmaceuticals |
| NCT04935294 | Phase 1 | Jan 24, 2018 | Alexion |
| NCT03384186 | Phase 1 | Dec 1, 2017 | Achillion Pharmaceuticals, Quotient |
| NCT04889391 | Phase 1 | Sep 14, 2017 | Alexion |
| NCT03124368 | Phase 2 | Jul 1, 2017 | Achillion Pharmaceuticals |
Showing 20 of 27 trials
Page 1 / 2
Organizations
Research & Development (8)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Alexion | For profit | 17 | 17 | 4 | 2016 |
| Achillion Pharmaceuticals | For profit | 9 | 9 | 2 | 2017 |
| Celerion | For profit | 3 | 0 | 1 | 2019 |
| Auckland Clinical Studies | For profit | 1 | 0 | 1 | 2017 |
| National Institute of Allergy and Infectious Diseases (NIAID) | Government | 1 | 1 | 1 | 2021 |
| Orlando Clinical Research Center | For profit | 1 | 0 | 1 | 2018 |
| Quotient | For profit | 1 | 0 | 1 | 2017 |
| University of Miami | Academic/Hospital | 1 | 0 | 1 | 2018 |
8 organizations
Page 1 / 1
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Alexion | For profit | MKTG | Mar 29, 2024 |
| AstraZeneca | For profit | NDA | Mar 29, 2024 |