Amvuttra

(Vutrisiran)

Phase 3RNA therapy

Vutrisiran is used to treat amyloidosis, an inherited disorder where abnormal proteins accumulate and damage nerves and the heart. This medication works by reducing the production of these harmful proteins in the body.[1] Amvuttra is currently being investigated across 1 indication[3], with its most advanced program in Phase 3.[1]

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Transthyretin Amyloidosis (ATTR) With CardiomyopathyEnrolling by invitation

Transthyretin Amyloidosis (ATTR) With CardiomyopathyPhase 3

Enrolling by invitation

Timeline

Expected Milestones

Q1 2027

Phase 3Active, not recruiting

Transthyretin Amyloidosis (ATTR) With Cardiomyopathy

NCT04153149

Q2 2031

Phase 3Recruiting

Amyloidosis

NCT07223203

Clinical

Trials by Indication[1]

Transthyretin Amyloidosis (ATTR) With Cardiomyopathy2 trials

HELIOS-B: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy (ATTR Amyloidosis With Cardiomyopathy)

Active, not recruiting· Alnylam Pharmaceuticals logo

Alnylam Pharmaceuticals·Phase 3·NCT04153149·655 enrolled

An Open-Label Extension Study to Assess the Safety and Efficacy of Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy (ATTR Amyloidosis With Cardiomyopathy)

Enrolling by invitation· Alnylam Pharmaceuticals logo

Alnylam Pharmaceuticals·Phase 3·NCT06679946·700 enrolled

Hereditary Transthyretin Amyloidosis1 trial

HELIOS-A: A Study of Vutrisiran (ALN-TTRSC02) in Patients With Hereditary Transthyretin Amyloidosis (hATTR Amyloidosis)

Completed· Alnylam Pharmaceuticals logo

Alnylam Pharmaceuticals·Phase 3·NCT03759379·164 enrolled

Amyloidosis1 trial

TRITON-PN: A Phase 3, Global, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Nucresiran in Patients With Hereditary Transthyretin-Mediated Amyloidosis With Polyneuropathy (hATTR-PN)

Recruiting· Alnylam Pharmaceuticals logo

Alnylam Pharmaceuticals·Phase 3·NCT07223203·125 enrolled

Regulatory

FDA Approval Timeline[4]

Jun 13, 2022

AMVUTTRA

NDA NDA215515

Sources

References

[1]
ClinicalTrials.gov — 4 trial records for Vutrisiran. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Vutrisiran compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Vutrisiran. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA215515). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Amvuttra. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Alnylam Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: RNA therapy[2]
Highest Phase: Phase 3[1]
Company: Alnylam Pharmaceuticals

Patent Landscape[5]

Patent Cliff

Dec 4, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9370581Dec 4, 2028

10806791Dec 4, 2028

9399775Nov 16, 2032

10570391Nov 16, 2032

10612024Aug 14, 2035

5 more patents

11401517Aug 14, 2035

10208307Jul 28, 2036

10683501Jul 28, 2036

12049628Jul 28, 2036

11286486Jul 28, 2036