plozasiran
Nucleic acidapprovedOrphan Drug FDA
Approved
Nov 18, 2025
Clinical trial activity
13 trials · 2 clinical orgs · 1 marketing orgs
Phase 1
2
Phase 2
10
Phase 3
7
Phase 4
0
Earliest trial started Mar 8, 2019 (NCT03783377)
Timeline
2010s
- Jan 1, 2019
Arrowhead Pharmaceuticals — Earliest Phase 1 Sponsor(trial)
- Jun 20, 2019
Orphan Drug Designation
2020s
- Jan 1, 2021
Arrowhead Pharmaceuticals — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2021
Arrowhead Pharmaceuticals — Earliest Phase 3 Sponsor(trial)
- Nov 18, 2025
Earliest FDA Approval
- Nov 18, 2025
Arrowhead Pharmaceuticals — Marketing Organization
Indications
Approved for
Mechanism of action
- Apolipoprotein C-IIIINHIBITOR
APOC3 inhibitor
Approval history
- approvedNov 18, 2025
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Multi-specific
- No
Oral
No
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL6068439 ↗
- ChEMBLCHEMBL6068438 ↗
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06880770 | Phase 3 | Apr 24, 2025 | Arrowhead Pharmaceuticals |
| NCT06822790 | Phase 3 | Mar 31, 2025 | Arrowhead Pharmaceuticals |
| NCT06347016 | Phase 3 | Jul 23, 2024 | Arrowhead Pharmaceuticals |
| NCT06347003 | Phase 3 | Jul 22, 2024 | Arrowhead Pharmaceuticals |
| NCT06347133 | Phase 3 | May 21, 2024 | Arrowhead Pharmaceuticals |
| NCT05902598 | Phase 3 | Jul 1, 2023 | Visirna Therapeutics HK Limited |
| NCT05757596 | Phase 1 | Jun 1, 2023 | Arrowhead Pharmaceuticals, Visirna Therapeutics HK Limited |
| NCT05413135 | Phase 2 | Jul 7, 2022 | Arrowhead Pharmaceuticals |
| NCT05089084 | Phase 3 | Nov 30, 2021 | Arrowhead Pharmaceuticals |
| NCT04998201 | Phase 2 | Oct 31, 2021 | Arrowhead Pharmaceuticals |
| NCT04720534 | Phase 2 | May 31, 2021 | Arrowhead Pharmaceuticals |
| NCT03783377 | Phase 1 | Mar 8, 2019 | Arrowhead Pharmaceuticals |
| NCT06796426 | N/A | — | Arrowhead Pharmaceuticals |
Showing 13 of 13 trials
Page 1 / 1
Organizations
Research & Development (2)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Arrowhead Pharmaceuticals | For profit | 12 | 11 | 4 | 2019 |
| Visirna Therapeutics HK Limited | For profit | 2 | 2 | 2 | 2023 |
2 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Arrowhead Pharmaceuticals | For profit | MKTG | Nov 18, 2025 |