FDA · United States
patisiran sodium — FDA regulatory status
patisiran sodium (ONPATTRO) regulatory status in the United States is tracked from public FDA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: FDA approved.
Status snapshot
- Status
- FDA approved
- Brand
- ONPATTRO
- Originator
- Alnylam Netherlands B.V.
- Mechanism
- Transthyretin mRNA RNAi inhibitor
- Target
- Transthyretin mRNA
- Structured fields
- 8
Sponsor / originator context: Alnylam Netherlands B.V.. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: Transthyretin mRNA RNAi inhibitor. Target: Transthyretin mRNA. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 7 published clinical programs and 12 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| FDA | United States | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| ALN-TTR02-011 | Phase 3 | Alnylam Netherlands | 2023-508364-29-00 |
| ALN-TTRSC02-002 | Phase 3 | Alnylam Netherlands | 2023-508365-33-00 |
| Patisiran | Phase 3 | Alnylam Netherlands | NCT03759379 |
| Patisiran | Phase 3 | Alnylam Netherlands | NCT03862807 |
| Patisiran | Phase 3 | Alnylam Netherlands | NCT02510261 |
| Patisiran | Phase 2 | Alnylam Netherlands | NCT01617967 |
| patisiran | Phase 1 | Alnylam Netherlands | NCT05023889 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 12416006 | Cell death-inducing DFFA-like effector B (CIDEB) iRNA compositions and methods of use thereof | US |
| 12404508 | Ketohexokinase (KHK) iRNA compositions and methods of use thereof | US |
| 12397013 | Extrahepatic delivery | US |
| 12364762 | Biodegradable lipids for the delivery of active agents | US |
| 12350338 | Biodegradable lipids for the delivery of active agents | US |
| 12343398 | Biodegradable lipids for the delivery of active agents | US |
| 12331297 | Coagulation factor V (F5) iRNA compositions and methods of use thereof | US |
| 12241064 | REVERSIR™ compounds | US |
| 12239709 | Biodegradable lipids for the delivery of active agents | US |
| 12227744 | Compositions and methods for inhibiting expression of transthyretin | US |
| 12173289 | Hepatitis B virus (HBV) dsRNA agent compositions and methods of use thereof | US |
| 12173288 | Oligonucleotide-ligand conjugates and process for their preparation | US |
Related hubs
FAQ
What is the FDA approval status of patisiran sodium?
patisiran sodium currently shows FDA approved in our United States regulatory index. Confirm on the official FDA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get patisiran sodium regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to patisiran sodium?
This spoke lists 7 published programs associated with patisiran sodium in our pipeline index.