vadadustat
Trade name: VAFSEO
Approved
Mar 27, 2024
Vadadustat, sold under the brand name Vafseo, is a medication used for the treatment of symptomatic anemia associated with chronic kidney disease. Vadadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor. — Wikipedia
Clinical trial activity
40 trials · 6 clinical orgs · 1 marketing orgs
Earliest trial started Jul 8, 2010 (NCT04707573)
Timeline
2010s
- Jan 1, 2010
Akebia Therapeutics — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2014
Akebia Therapeutics — Earliest Phase 1 Sponsor(trial)
- Jan 1, 2015
Akebia Therapeutics — Earliest Phase 3 Sponsor(trial)
2020s
- Mar 27, 2024
Akebia Therapeutics — Earliest FDA Approval
- Mar 27, 2024
Akebia Therapeutics — NDA Organization
Indications
Studied for
- Anemia · Phase 3
- Chronic Kidney Disease-Mineral and Bone Disorder · Phase 3
- Coronavirus Infections · Phase 2
- Drug Interactions · Phase 1
- Hamartoma · Phase 3
- Healthy Volunteers · Phase 3
- Kidney Diseases · Phase 2
- Kidney Failure, Chronic · Phase 2
- Liver Diseases · Phase 1
- Pharmacokinetics · Phase 1
- Renal Insufficiency, Chronic · Phase 2
- Respiratory Distress Syndrome · Phase 2
Mechanism of action
- Egl nine homolog 1INHIBITOR
EGLN1 inhibitor
Hypoxia-inducible factor prolyl hydroxylase 1 inhibitor
May exert its effect on renal anemia by increasing Hb via activation of the HIF pathway. Active against PHD1-3 but activity against PHD2 may be the most significant for the therapeutic effect.
- Egl nine homolog 3INHIBITOR
Egl nine homolog 3 inhibitor
May exert its effect on renal anemia by increasing Hb via activation of the HIF pathway. Active against PHD1-3 but activity against PHD2 may be the most significant for the therapeutic effect.
Approval history
- approvedMar 27, 2024
Chemistry & pharmacology
SMILES
O=C(O)CNC(=O)c1ncc(-c2cccc(Cl)c2)cc1O- Mol. weight
- 306.71 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- WikipediaVadadustat ↗
- ChEMBLCHEMBL3646221 ↗
Also known as
- akb-6548
- akb-6548
- akb-6548
- pg-1016548
- pg-1016548
- vadadustat
- vadadustat
- vadadustat
- vadadustat
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07086755 | Phase 2/Phase 3 (Phase 3) | Oct 23, 2025 | Akebia Therapeutics, University of Texas at Houston |
| NCT06901505 | Phase 3 | Jul 24, 2025 | Akebia Therapeutics |
| NCT06520826 | Phase 3 | Oct 1, 2024 | Akebia Therapeutics, USRC Kidney Research |
| NCT05082584 | Phase 3 | Nov 30, 2021 | Akebia Therapeutics |
| NCT05082571 | Phase 3 | Nov 30, 2021 | Akebia Therapeutics |
| NCT04707768 | Phase 3 | Jul 21, 2021 | Akebia Therapeutics |
| NCT04478071 | Phase 2 | Aug 22, 2020 | Akebia Therapeutics, University of Texas at Houston |
| NCT04313153 | Phase 3 | Apr 30, 2020 | Akebia Therapeutics, Otsuka |
| NCT04299633 | Phase 1 | Mar 31, 2020 | Akebia Therapeutics |
| NCT03992066 | Phase 1 | May 28, 2019 | Akebia Therapeutics |
| NCT03799627 | Phase 2 | Jan 31, 2019 | Akebia Therapeutics, Sponsor GmbH |
| NCT03789032 | Phase 1 | Oct 3, 2018 | Akebia Therapeutics, Sponsor GmbH |
| NCT03645863 | Phase 3 | Aug 27, 2018 | Mitsubishi Tanabe |
| NCT03657290 | Phase 1 | Aug 3, 2018 | Akebia Therapeutics, Sponsor GmbH |
| NCT03801746 | Phase 1 | Jul 20, 2018 | Akebia Therapeutics, Sponsor GmbH |
| NCT03801759 | Phase 1 | Jul 20, 2018 | Akebia Therapeutics, Sponsor GmbH |
| NCT03801733 | Phase 1 | Jun 17, 2018 | Akebia Therapeutics |
| NCT03799848 | Phase 1 | Jun 12, 2018 | Akebia Therapeutics |
| NCT03639155 | Phase 1 | Apr 12, 2018 | Akebia Therapeutics |
| NCT03461146 | Phase 3 | Mar 5, 2018 | Mitsubishi Tanabe |
Organizations
Research & Development (6)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Akebia Therapeutics | For profit | 35 | 32 | 3 | 2010 |
| Sponsor GmbH | Academic/Hospital | 6 | 0 | 3 | 2017 |
| Mitsubishi Tanabe | For profit | 5 | 5 | 1 | 2017 |
| University of Texas at Houston | Academic/Hospital | 2 | 2 | 2 | 2020 |
| Otsuka | For profit | 1 | 0 | 1 | 2020 |
| USRC Kidney Research | Academic/Hospital | 1 | 1 | 1 | 2024 |
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Akebia Therapeutics | For profit | NDA | Mar 27, 2024 |