aficamten
Small moleculeapprovedOrphan Drug FDA
Approved
Dec 19, 2025
Clinical trial activity
11 trials · 4 clinical orgs · 1 marketing orgs
Phase 1
3
Phase 2
7
Phase 3
6
Phase 4
0
Earliest trial started Nov 8, 2018 (NCT03767855)
Timeline
2010s
- Jan 1, 2018
Cytokinetics — Earliest Phase 1 Sponsor(trial)
2020s
- Jan 1, 2020
Cytokinetics — Earliest Phase 2 Sponsor(trial)
- Jan 5, 2021
Orphan Drug Designation
- Jan 1, 2022
Cytokinetics — Earliest Phase 3 Sponsor(trial)
- Dec 19, 2025
Earliest FDA Approval
- Dec 19, 2025
Cytokinetics — Marketing Organization
Indications
Approved for
Mechanism of action
Approval history
- approvedDec 19, 2025
Chemistry & pharmacology
Loading structure…
SMILES
CCc1nc(-c2ccc3c(c2)CC[C@H]3NC(=O)c2cnn(C)c2)no1- Mol. weight
- 337.38 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL4847050 ↗
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07023341 | Phase 3 | Jun 30, 2025 | Bayer |
| NCT06412666 | Phase 2/Phase 3 (Phase 3) | May 29, 2024 | Cytokinetics |
| NCT06116968 | Phase 3 | Nov 8, 2023 | Chinese Academy of Medical Sciences, Ji Xing Pharmaceuticals (Shanghai) Co., Ltd. |
| NCT06081894 | Phase 3 | Aug 30, 2023 | Cytokinetics |
| NCT05767346 | Phase 3 | Jun 19, 2023 | Cytokinetics |
| NCT05924815 | Phase 1 | May 15, 2023 | Cytokinetics |
| NCT05186818 | Phase 3 | Feb 1, 2022 | Cytokinetics, Ji Xing Pharmaceuticals (Shanghai) Co., Ltd. |
| NCT04848506 | Phase 2 | May 6, 2021 | Cytokinetics |
| NCT04783766 | Phase 1 | Apr 10, 2021 | Cytokinetics, Ji Xing Pharmaceuticals (Shanghai) Co., Ltd. |
| NCT04219826 | Phase 2 | Jan 31, 2020 | Cytokinetics |
| NCT03767855 | Phase 1 | Nov 8, 2018 | Cytokinetics |
Showing 11 of 11 trials
Page 1 / 1
Organizations
Research & Development (4)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Cytokinetics | For profit | 9 | 8 | 3 | 2018 |
| Ji Xing Pharmaceuticals (Shanghai) Co., Ltd. | For profit | 3 | 2 | 2 | 2021 |
| Bayer | For profit | 1 | 1 | 1 | 2025 |
| Chinese Academy of Medical Sciences | Academic/Hospital | 1 | 0 | 1 | 2023 |
4 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Cytokinetics | For profit | MKTG | Dec 19, 2025 |