Stealth BioTherapeutics

Focus: Stealth BioTherapeutics is a publicly traded biotech company focused on mitochondrial disease therapies, with a lead product (FORZINITY/elamipretide) recently launched for muscle strength in adults. The company operates from Needham, MA with a specialized focus on rare mitochondrial diseases.

Unknown Rare Diseases

Profile data last refreshed Yesterday · AI intelligence enriched 2w ago

Funding Stage

PUBLIC

Open Jobs

About Stealth BioTherapeutics

AI assessmentNot Hiring

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Why Work Here

Data completeness

3/9 — Basic

Company HealthStrong

Pipeline

Late-stage

3 Phase 3+

LOE Risk

Protected

No near-term cliffs

Hiring

0 open

Automated analysis based on publicly available data (FDA, SEC, ClinicalTrials.gov). May be incomplete or delayed. This score does not reflect insider knowledge and should not be used as the sole basis for investment or employment decisions.

Key Products

FORZINITY

Muscle strength in adult patients with mitochondrial disease

Launch7.8yr

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.

Commercial momentum: 4 open sales roles indicate active market launch phase for FORZINITY with revenue generation underway
Deep pipeline focus: 29 active programs spanning Phase 1-3 trials across mitochondrial diseases, ARMD, heart failure, and rare indications suggest sustained R&D investment
Specialized expertise: Rare disease focus on mitochondrial biology offers unique scientific depth and potential for meaningful therapeutic impact in underserved populations

Pipeline & Clinical Trials

An Observational Study of Patients With Primary Mitochondrial Disease (SPIMM-300)

Primary Mitochondrial Disease

N/A

Clinical Trials (1)

NCT03048617An Observational Study of Patients With Primary Mitochondrial Disease (SPIMM-300)

N/A

elamipretide

Mitochondrial Diseases

N/A

Clinical Trials (1)

NCT04689360An Intermediate Size Expanded Access Protocol of Elamipretide

N/A

Bendavia 10mg

Healthy

PHASE_1

Clinical Trials (1)

NCT01754818A Phase 1 Study Examining the Pharmacokinetics and Tolerability of a Single Oral Dose of Bendavia (MTP-131)

Phase 1

MTP-131

Heart Failure

PHASE_1

Clinical Trials (1)

NCT02388529A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Bendavia™ (MTP-131) in Patients With Heart Failure

Phase 1

Bendavia 10mg

Healthy Volunteers

PHASE_1

Clinical Trials (1)

NCT01786915Safety and Pharmacokinetic (PK) Study of Oral Bendavia Administered for 7 Days

Phase 1

Unfractionated heparin

Healthy Volunteers

PHASE_1

Clinical Trials (1)

NCT01513200Study to Assess the Pharmacodynamic Effects of Unfractionated Heparin (UFH) in Healthy Volunteers With and Without Bendavia

Phase 1

MTP-131

Congestive Heart Failure

PHASE_1

Clinical Trials (1)

NCT02388464A Study Investigating the Safety, Tolerability, and Pharmacokinetics of MTP-131 in Subjects With Congestive Heart Failure

Phase 1

Elamipretide

Age-Related Macular Degeneration

PHASE_1

Clinical Trials (1)

NCT02848313An Open-Label, Phase 1 Clinical Study to Evaluate the Safety and Tolerability of Subcutaneous Elamipretide in Subjects With Intermediate Age-Related Macular Degeneration

Phase 1

MTP-131

Normal and Impaired Renal Function

PHASE_1

Clinical Trials (1)

NCT02436447A Phase 1 Study Investigating the Safety and Pharmacokinetics of Repeat-dose Intravenous Infusion of MTP-131 in Subjects With Impaired Renal Function

Phase 1

MTP-131

Healthy

PHASE_1

Clinical Trials (1)

NCT01115920Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of Intravenous (IV) Infusion of MTP-131 (Bendavia™) in Healthy Adults

Phase 1

Bendavia

Healthy Volunteers

PHASE_1

Clinical Trials (1)

NCT01518985The Impact of Intravenous Bendavia™ on Endothelial Reactivity Dysfunction in Cigarette Smoking

Phase 1

Elamipretide

Friedreich Ataxia

PHASE_1_2

Bendavia

Renal Artery Obstruction

PHASE_1_2

Clinical Trials (1)

NCT01755858Effects of Intravenous Bendavia™ on Reperfusion Injury in Patients Undergoing Angioplasty of the Renal Artery

Phase 1/2

elamipretide

Mitochondrial Myopathy

PHASE_1_2

Clinical Trials (1)

NCT02367014Safety, Tolerability, and Efficacy of MTP-131 for the Treatment of Mitochondrial Myopathy

Phase 1/2

Part A Elamipretide 1.0% Ophthalmic Solution

Fuchs' Corneal Endothelial Dystrophy (FCED)

PHASE_1_2

Clinical Trials (1)

NCT02653391A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for the Treatment of Fuchs' Corneal Endothelial Dystrophy (FCED)

Phase 1/2

MTP-131

Diabetic Macular Edema

PHASE_1_2

Clinical Trials (1)

NCT02314299A Study of MTP-131 Topical Ophthalmic Solution in Subjects With Diabetic Macular Edema and Non-Exudative Intermediate Age-related Macular Degeneration

Phase 1/2

Bendavia

Reperfusion Injury

PHASE_2

Clinical Trials (1)

NCT01572909Evaluation of Myocardial Effects of MTP-131 for Reducing Reperfusion Injury in Patients With Acute Coronary Events

Phase 2

Elamipretide will be supplied as a sterile 5.0 mL single-patient, multi-dose glass vial containing 3.75 mL of elamipretide solution

Aging, Healthy

PHASE_2

Clinical Trials (1)

NCT07275424Study of Healthy Aging and Physical Function With Elamipretide

Phase 2

elamipretide

Leber's Hereditary Optic Neuropathy

PHASE_2

Clinical Trials (1)

NCT02693119A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for Treatment of Leber's Hereditary Optic Neuropathy

Phase 2

Elamipretide

Skeletal Muscle Mitochondrial Dysfunction in the Elderly

PHASE_2

Clinical Trials (1)

NCT02245620A Phase 2 Study to Evaluate the Impact of MTP-131 (Bendavia™) on Skeletal Muscle Function in Elderly

Phase 2

elamipretide

Heart Failure

PHASE_2

Clinical Trials (1)

NCT02914665A 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

Phase 2

elamipretide

Primary Mitochondrial Disease

PHASE_2

Clinical Trials (1)

NCT02976038Open-Label Extension Trial to Characterize the Long-term Safety and Tolerability of Elamipretide in Subjects With Genetically Confirmed Primary Mitochondrial Myopathy (PMM)

Phase 2

Elamipretide

Primary Mitochondrial Disease

PHASE_2

Clinical Trials (1)

NCT02805790Safety, Tolerability, Efficacy of MTP-131 for Treatment of Mitochondrial Disease in Subjects From the MMPOWER Study

Phase 2

elamipretide

Chronic Heart Failure

PHASE_2

Clinical Trials (1)

NCT02814097A 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

Phase 2

4 mg elamipretide

Heart Failure

PHASE_2

Clinical Trials (1)

NCT02788747Effect of Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Reduced Ejection Fraction

Phase 2

Subcutaneous elamipretide through the elamipretide delivery system

Age-related Macular Degeneration

PHASE_2

Clinical Trials (1)

NCT03891875ReCLAIM-2 Study to Evaluate Safety,Efficacy & Pharmacokinetics of Elamipretide in Subjects With AMD With Non-central GA

Phase 2

Elamipretide

Barth Syndrome

PHASE_2_3

Clinical Trials (1)

NCT03098797A Trial to Evaluate Safety, Tolerability and Efficacy of Elamipretide in Subjects With Barth Syndrome

Phase 2/3

Elamipretide

Age Related Macular Degeneration (ARMD)

PHASE_3

Clinical Trials (1)

NCT06373731ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD)

Phase 3

elamipretide

Primary Mitochondrial Myopathy

PHASE_3

Clinical Trials (2)

NCT07531251Ph3b/4 Trial in Patients With Barth Syndrome

Phase 4

NCT03323749A Trial to Evaluate Safety and Efficacy of Elamipretide Primary Mitochondrial Myopathy Followed by Open-Label Extension

Phase 3

Elamipretide

Mitochondrial Myopathies

PHASE_3