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Lexeo Therapeutics

Lexeo Therapeutics works on 2 rare diseases tracked on Trial Friend, including Arrhythmogenic Cardiomyopathy, Friedreich Ataxia, with 5 active clinical trials (3 recruiting).

Lexeo Therapeutics is a New York gene therapy company focused on genetic heart disease, a space most gene therapy developers avoided while chasing neurological and blood disorders. Its lead program, LX2006, delivers a working copy of the frataxin gene to heart muscle in Friedreich ataxia, where cardiomyopathy, not the better-known neurological decline, is the leading cause of death.

The program has collected nearly every FDA acceleration mechanism available: Breakthrough Therapy, Regenerative Medicine Advanced Therapy, Fast Track, and orphan drug designations, on the strength of interim Phase 1/2 data showing reductions in abnormal left ventricular mass and improvements in cardiac biomarkers. In 2026 Lexeo launched SUNRISE-FA 2, the pivotal study intended to support an accelerated-approval BLA in 2028. For Friedreich ataxia families, it is the first serious attempt to treat the disease's deadliest feature at its genetic root.

The second program, LX2020, targets PKP2 arrhythmogenic cardiomyopathy, an inherited arrhythmia disease that can cause sudden cardiac death in young, otherwise healthy people, and holds its own RMAT designation. Both programs use AAV delivery refined for cardiac tissue, the company's core bet.

Type
Rare Disease Specialist
Ticker
LXEO
Headquarters
New York, United States
5
Active Rare Disease Trials
2
Rare Diseases in Portfolio

Lexeo Therapeutics Drug Pipeline

Lexeo Therapeutics has 5 active clinical trials across 2 development stages, with 3 currently recruiting participants. Clinical trials advance through phases: Phase 1 tests safety in a small group, Phase 2 evaluates effectiveness and side effects, Phase 3 confirms benefit in a larger population, and Phase 4 monitors long-term safety after FDA approval.

Note: This pipeline counts the active and recruiting trials listed on this page, from ClinicalTrials.gov. For companies that work outside rare disease, we list only trials for rare diseases we track, so the company's full pipeline may be larger.

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3
Phase 23 trials
Recruiting
Active Not Recruiting
Active Not Recruiting
2
Other2 trials
Recruiting

Lexeo Therapeutics Clinical Trials (5)

Active and recruiting clinical trials sponsored by Lexeo Therapeutics, sourced live from ClinicalTrials.gov. Each trial card shows the study phase, current recruitment status, conditions under investigation, study locations, eligibility criteria, and a direct link to the full ClinicalTrials.gov record. You can also download a one-page PDF summary to share with your doctor.

Note: Recruitment statuses on ClinicalTrials.gov may not immediately reflect recent FDA decisions, sponsor announcements, or enrollment changes. Always confirm a trial's current status directly with the study coordinator.

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RECRUITINGRecently updatedNCT06865482

Clinical Course Of Disease In Participants With FA-CM

Friedreich AtaxiaCardiomyopathy

Characteristics and clinical course of disease In participants with cardiomyopathy associated with Friedreich Ataxia (CLARITY-FA)

Ages 6 Years+19 locations
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RECRUITINGPHASE2Recently updatedNCT07721025

Study of LX2006 Gene Therapy in Friedreich Ataxia Cardiomyopathy

Intervention: LX2006, Usual Care

Friedreich AtaxiaCardiomyopathy, Secondary

The purpose of Study LX2006-03, a multicenter, Phase 2, open-label, randomized, controlled study, is to evaluate the efficacy and safety of LX2006 gene therapy in participants with Friedreich ataxia (FA) cardiomyopathy (CM).

Ages 6 Years+1 location
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RECRUITINGHasn't posted an update in over a yearNCT06976606

A Study to Assess Real-world Patient Characteristics and Clinical Course for Symptomatic Patients With PKP2-ACM

An observational study to assess real-world patient characteristics and clinical course of disease in participants with PKP2-ACM.

Ages 18 Years - 65 Years6 locations
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ACTIVE NOT RECRUITINGPHASE1, PHASE2No updates in a whileNCT05445323

Gene Therapy for Cardiomyopathy Associated With Friedreich's Ataxia

Intervention: Low dose LX2006, Mid Dose LX2006, High Dose LX2006

Friedreich AtaxiaCardiomyopathy, Secondary

This is a Phase 1/2, open-label, dose-ascending, multicenter study of the safety and efficacy of LX2006 for participants who have Friedreich's Ataxia with evidence of cardiomyopathy. The study will evaluate up to three doses of single administration of LX2006 (AAVrh.10hFXN), an adeno-associated virus (AAV) gene therapy designed to intravenously deliver the human frataxin (hFXN) gene to cardiac cells over a 52-week period. Long-term safety and efficacy will be evaluated for an additional 4-years for a total of 5-years post LX2006 treatment.

Ages 18 Years - 50 Years3 locations
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ACTIVE NOT RECRUITINGPHASE1, PHASE2No updates in a whileNCT06109181

Gene Therapy for ACM Due to a PKP2 Pathogenic Variant

Intervention: LX2020

This is a Phase 1/2, first-in-human, open-label, intravenous, dose-escalating, multicenter trial that is designed to assess the safety and tolerability of LX2020 in adult patients with PKP2-ACM

Ages 18 Years - 65 Years5 locations
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FDA-Approved Drugs

No FDA-approved drugs found for this company at this time.

Lexeo Therapeutics Trial Locations

Lexeo Therapeutics clinical trials are running at 34 sites in 8 countries. Click any country to drill down by state, city, and individual research facility. Proximity to a trial site is one of the most important factors in deciding whether to participate.

United States
23▼
Brazil
5▼
Canada
1▼
Czechia
1▼
France
1▼
Germany
1▼
Italy
1▼
Spain
1▼

Rare Disease Focus Areas (2)

Diseases targeted by Lexeo Therapeutics's clinical trial and drug development programs

Patient Resources

Organizations and resources related to Lexeo Therapeutics's rare disease focus areas

Frequently Asked Questions About Lexeo Therapeutics

Common questions about Lexeo Therapeutics's rare disease programs, clinical trials, and treatments.