Forzinity

(elamipretide)

ApprovedPeptide

SStealth BioTherapeutics Inc.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Barth SyndromeRecruiting

Barth SyndromeApproved

Recruiting

Timeline

Expected Milestones

Q3 2027

Phase 3Active, not recruiting

Age-Related Macular Degeneration

NCT06373731

Q4 2029

ApprovedRecruiting

Barth Syndrome

NCT07531251

Clinical

Trials by Indication[1]

Heart Failure3 trials

A Study to Evaluate the Effects of 4 Weeks Treatment With Subcutaneous Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Preserved Ejection Fraction

Completed·SStealth BioTherapeutics Inc.·Phase 2·NCT02814097·46 enrolled

Effect of Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Reduced Ejection Fraction

Completed·SStealth BioTherapeutics Inc.·Phase 2·NCT02788747·71 enrolled

A Phase 2 Study to Evaluate the Cardiac and Renal Effects of Short Term Treatment With Elamipretide in Patients Hospitalized With Congestion Due to Heart Failure

Completed·SStealth BioTherapeutics Inc.·Phase 2·NCT02914665·308 enrolled

Age-Related Macular Degeneration2 trials

An Open-Label, Phase 1 Clinical Study to Evaluate the Safety and Tolerability of Subcutaneous Elamipretide in Subjects With Intermediate Age-Related Macular Degeneration

Completed·SStealth BioTherapeutics Inc.·Phase 1·NCT02848313·40 enrolled

ReNEW: A Phase 3, Double-Masked, Placebo-Controlled Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects Who Have Dry Age-Related Macular Degeneration (Dry AMD)

Active, not recruiting·SStealth BioTherapeutics Inc.·Phase 3·NCT06373731·313 enrolled

Myopathy2 trials

Open-Label Extension Trial to Characterize the Long-term Safety and Tolerability of Elamipretide in Subjects With Genetically Confirmed Primary Mitochondrial Myopathy (PMM)

Terminated·SStealth BioTherapeutics Inc.·Phase 2·NCT02976038·28 enrolled

Safety, Tolerability, and Efficacy of MTP-131 for the Treatment of Mitochondrial Myopathy

Completed·SStealth BioTherapeutics Inc.·Phase 1/2·NCT02367014·36 enrolled

Mitochondrial Disease2 trials

Study to Evaluate Efficacy and Safety of Elamipretide in Subjects With Primary Mitochondrial Disease From Nuclear DNA Mutations (nPMD)

Completed·SStealth BioTherapeutics Inc.·Phase 3·NCT05162768·102 enrolled

Safety, Tolerability, Efficacy of MTP-131 for Treatment of Mitochondrial Disease in Subjects From the MMPOWER Study

Completed·SStealth BioTherapeutics Inc.·Phase 2·NCT02805790·30 enrolled

Efficacy1 trial

A Trial to Evaluate Safety, Tolerability and Efficacy of Elamipretide in Subjects With Barth Syndrome

Completed·SStealth BioTherapeutics Inc.·Phase 2/3·NCT03098797·12 enrolled

4 more indications

ESS1 trial

An Intermediate Size Expanded Access Protocol of Elamipretide

Available·SStealth BioTherapeutics Inc.··NCT04689360

TIA1 trial

FRDA Investigator Initiated Study (IIS) With Elamipretide

Completed·—·Phase 1/2·NCT05168774·20 enrolled

Function1 trial

A Phase 2 Study to Evaluate the Impact of MTP-131 (Bendavia™) on Skeletal Muscle Function in Elderly

Completed·SStealth BioTherapeutics Inc.·Phase 2·NCT02245620·41 enrolled

Barth Syndrome1 trial

Phase 3b/4, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Trial to Evaluate the Efficacy and Safety of Daily Subcutaneous Injections of Elamipretide in Patients With Genetically Confirmed Barth Syndrome

Recruiting·SStealth BioTherapeutics Inc.·Approved·NCT07531251·48 enrolled

Regulatory

FDA Approval Timeline[4]

Sep 19, 2025

FORZINITY

NDA NDA215244

Sources

References

[1]
ClinicalTrials.gov — 14 trial records for elamipretide. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — elamipretide compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for elamipretide. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA215244). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Forzinity. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Stealth BioTherapeutics Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Peptide[2]
Highest Phase: Approved[1]
Company: SStealth BioTherapeutics Inc.

Patent Landscape[5]

Patent Cliff

Jan 20, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7576061Jan 20, 2027

12268724Feb 28, 2034

11771734Feb 28, 2034

11083772Feb 28, 2034

11083771Feb 28, 2034

1 more patents

9687519Feb 28, 2034