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RP-A601

Phase 1

PKP2 Arrhythmogenic Cardiomyopathy (PKP2-ACM) | Gene therapy | Cardiovascular |Rocket Pharmaceuticals, Inc.|Last Updated: Apr 16, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment9

FDA Designations

RMAT

Clinical trial landscape

RP-A601 · 1 trial · 1 indication

Phase 1 1
NCT05885412A Phase 1, Dose Escalation Trial of RP-A601 in Subjects With PKP2 Variant-Mediated Arrhythmogenic Cardiomyopathy (PKP2-ACM)PKP2 Arrhythmogenic Cardiomyopathy (PKP2-ACM)
RECRUITING9 Analytics
PHASE1RECRUITING
A Phase 1, Dose Escalation Trial of RP-A601 in Subjects With PKP2 Variant-Mediated Arrhythmogenic Cardiomyopathy (PKP2-ACM)
PKP2 Arrhythmogenic Cardiomyopathy (PKP2-ACM)Unlock trial analytics

Study Endpoints

Primary Endpoints

Evaluation of safety associated with RP-A601
12 months post-infusion

Incidence of treatment emergent adverse events (TEAEs), incidence of Serious Adverse Events (SAEs), and identification of Dose Limiting Toxicities (DLTs)

Secondary Endpoints

Preliminary efficacy of RP-A601 - Myocardial PKP2 protein expression
12 months post-infusion
Preliminary efficacy of RP-A601 - Ventricular ectopy and arrhythmia
12 months post-infusion
Preliminary efficacy of RP-A601 - Cardiac biomarkers
12 months post-infusion
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RP-A601EXPERIMENTALSingle ascending dose of RP-A601 in 2 consecutive cohorts

Interventions

NameTypeDescription
RP-A601GENETICRP-A601 is a recombinant viral vector composed of an AAV serotype rh.74 (AAVrh.74) capsid encapsulating the transgene, human plakophilin 2 (PKP2), transcript variant 2a (PKP2a)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Key Inclusion Criteria: 1. Male or female ≥18 years at the time of signing the informed consent 2. Capable and willing to provide signed informed consent 3. Clinical diagnosis of ACM as defined by the 2010 revised Task Force Criteria (TFC) 4. Documentation of a pathogenic or likely pathogenic trunc...

Countries:United States
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Competitive Landscape -Arrhythmogenic Right Ventricular Cardiomyopathy 3 trials (matched to "PKP2 Arrhythmogenic Cardiomyopathy (PKP2-ACM)")

CompanyTickerTrialsLead PhaseDrugs
Lexeo Therapeutics, Inc.LXEO3PHASE1LX2020
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Frequently asked questions about RP-A601

What is RP-A601 used for?

RP-A601 is an investigational gene therapy being developed for the treatment of PKP2 Arrhythmogenic Cardiomyopathy (PKP2-ACM), a cardiovascular condition. It is currently in Phase 1 clinical development and has not been approved by the FDA.

Who makes RP-A601?

RP-A601 is being developed by Rocket Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker RCKT. The company is conducting a Phase 1 clinical trial to evaluate the safety and efficacy of RP-A601 in patients with PKP2-ACM.

What phase is RP-A601 in?

RP-A601 is currently in Phase 1 clinical development. It is an investigational gene therapy and has not received FDA approval. The ongoing Phase 1 trial is a dose escalation study designed to assess the safety and tolerability of RP-A601 in patients with PKP2-ACM.

What clinical trials is RP-A601 in?

RP-A601 is being studied in a Phase 1 clinical trial with the identifier NCT05885412. This is a dose escalation trial enrolling approximately 9 participants with PKP2 variant-mediated Arrhythmogenic Cardiomyopathy. The trial is currently recruiting participants in the United States and is not randomized or blinded.

Is RP-A601 the same as PKP2-ACM treatment?

RP-A601 is a gene therapy specifically designed to treat PKP2 Arrhythmogenic Cardiomyopathy (PKP2-ACM), a condition caused by variants in the PKP2 gene. It is not the same as the disease itself; rather, it is an investigational therapeutic approach targeting the underlying genetic cause of the condition.