Regenxbio

Regenxbio works on 6 rare diseases tracked on Trial Friend, including Batten Disease, Duchenne Muscular Dystrophy, Geographic Atrophy and 3 more, with 5 recruiting clinical trials.

Regenxbio is a clinical-stage biotechnology company advancing gene therapies for rare and retinal diseases using its proprietary AAV gene therapy delivery platform. The company's pipeline includes therapies for mucopolysaccharidosis disorders, Duchenne muscular dystrophy, and inherited retinal diseases.

Type
Rare Disease Specialist
Ticker
RGNX
Headquarters
Rockville, United States
Founded
2009
5
Active Rare Disease Trials
6
Rare Diseases in Portfolio
17
Years Active

Focus areas at Regenxbio

As a rare disease specialist, Regenxbio has active clinical trial programs and drug development efforts across 6 rare diseases, including Batten Disease, Duchenne Muscular Dystrophy, Geographic Atrophy, Homozygous Familial Hypercholesterolemia, Hunter Syndrome, and 1 additional rare conditions. These programs may span orphan drug designation, novel therapeutic mechanisms, and precision medicine approaches targeting the underlying causes of each disease.

The clinical trials section below shows all active and recruiting studies sponsored by Regenxbio, sourced live from ClinicalTrials.gov. Each trial includes its current recruitment status, study phase (Phase 1 through Phase 4), conditions under investigation, and the number of active trial sites. The FDA-approved drugs section lists treatments that have received U.S. Food and Drug Administration approval, with brand names, generic names, approval dates, and matched rare disease indications from the openFDA database.

Regenxbio is headquartered in Rockville, United States, founded in 2009, publicly traded under the ticker symbol RGNX. The company dedicates its research and development resources exclusively to rare and orphan diseases, working to bring innovative treatments to patients with conditions that have historically had limited or no treatment options.

Regenxbio Drug Pipeline

Regenxbio has 5 active clinical trials across 2 development stages, with 5 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 includes all of Regenxbio's active interventional trials, not only those targeting rare diseases. We show the full pipeline because a company's broader research activity, therapeutic expertise, and development infrastructure directly shape its ability to advance rare disease programs. A strong overall pipeline often signals deeper clinical operations, faster enrollment capabilities, and greater commitment to bringing new treatments to patients.

Understand Regenxbio's pipeline
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4
Phase 34 trials
MPS II+1 more
Recruiting
AMD+4 more
Recruiting
1
Other1 trial

Regenxbio Clinical Trials (5)

Active and recruiting clinical trials sponsored by Regenxbio, 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.

Ask about Regenxbio's trials
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ACTIVE NOT RECRUITINGPHASE2, PHASE3Recently updatedNCT05693142

AFFINITY DUCHENNE: RGX-202 Gene Therapy in Participants With Duchenne Muscular Dystrophy (DMD)

Intervention: RGX-202

RGX-202 is a gene therapy designed to deliver a transgene for a novel microdystrophin that includes functional elements of naturally-occurring dystrophin including the C-Terminal (CT) domain. This is a multicenter, open-label dose evaluation clinical study to assess the safety, tolerability, and clinical efficacy of a one-time intravenous (IV) dose of RGX-202 in participants with Duchenne.

Ages 1 Year+23 locations
View full study
ACTIVE NOT RECRUITINGRecently updatedNCT05683379

AFFINITY BEYOND: Anti-AAV8 Antibody Assessment Study of Males With DMD

Intervention: AAV8 DetectCDx

This is an observational screening study to evaluate the prevalence of anti-adeno-associated serotype 8 (AAV8) antibodies in participants with Duchenne muscular dystrophy (DMD).

Ages 0 Years - 25 Years1 location
View full study
ACTIVE NOT RECRUITINGPHASE3Updated a few months agoNCT07236606

RGX-121-3102 Gene Therapy in Participants With MPS II (Hunter Syndrome)

Intervention: RGX-121-3102

RGX-121 is a gene therapy which is intended to deliver a functional copy of the iduronate-2-sulfatase gene (IDS) to the central nervous system. This study is a safety, efficacy, and pharmacodynamic dose ranging study to determine whether RGX-121 is safe, effective and well-tolerated by patients with MPS II (Hunter Syndrome)

Ages 4 Months - 5 Years1 location
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ACTIVE NOT RECRUITINGPHASE2, PHASE3Updated a few months agoNCT04704921

Pivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal Delivery One Time in Participants With nAMD

Intervention: ABBV-RGX-314, ABBV-RGX-314, Ranibizumab (LUCENTIS®)

AMDnAMDWet Age-related Macular DegenerationwAMDWet AMD

ABBV-RGX-314 (also known as RGX-314) is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD or nAMD). Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. Wet AMD is a significant cause of vision loss in the United States, Europe and Japan, with up to 2 million people living with wet AMD in these geographies alone. Current anti-vascular endothelial growth factor (anti-VEGF) therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to maintain or prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every 4 to 16 weeks in frequency, to maintain efficacy. Due to the burden of these treatments, patients often experience a decline in vision with reduced frequency of treatment over time.

Ages 50 Years - 89 Years89 locations
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ACTIVE NOT RECRUITINGPHASE2, PHASE3Hasn't posted an update in over a yearNCT03566043

CAMPSIITE™ RGX-121 Gene Therapy in Subjects With MPS II (Hunter Syndrome)

Intervention: RGX-121

RGX-121 is a gene therapy which is intended to deliver a functional copy of the iduronate-2-sulfatase gene (IDS) to the central nervous system. This study is a safety and efficacy, dose ranging study to determine whether RGX-121 is safe, effective and well-tolerated by patients with MPS II.

Ages 4 Months - 5 Years5 locations
View full study

FDA-Approved Drugs

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

Regenxbio Trial Locations

Regenxbio clinical trials are running at 119 sites in 3 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
114▼
Canada
4▼
Brazil
1▼

Rare Disease Focus Areas (6)

Diseases targeted by Regenxbio's clinical trial and drug development programs

Batten DiseaseNeurological & Neuromuscular

Batten disease is a rare inherited neurological disorder caused by mutations in genes affecting lysosomal function, leading to accumulation of lipofuscin (age pigment) in neurons. Progressive vision l...

Prevalence: Approximately 2-4 per 100,000 births in the U.S.; higher in certain populations (e.g., northern Europe)
Duchenne Muscular DystrophyNeurological & Neuromuscular

Duchenne muscular dystrophy is an X-linked genetic disorder causing progressive muscle weakness and degeneration, beginning in early childhood. The defective dystrophin protein normally protects muscl...

Prevalence: 1 in 3,500 to 5,000 male births
Geographic AtrophyEye & Vision

Geographic atrophy is the advanced form of dry age-related macular degeneration, characterized by progressive loss of retinal pigment epithelium, photoreceptors, and choriocapillaris in well-defined a...

Prevalence: Approximately 1 million people in the U.S.; affects about 20% of those with age-related macular degeneration
Homozygous Familial HypercholesterolemiaCardiovascular

Homozygous Familial Hypercholesterolemia is a severe genetic disorder causing extremely high cholesterol levels from birth, leading to early heart disease and cholesterol deposits in tendons and aroun...

Prevalence: Approximately 1 in 250,000 to 1 in 360,000 people globally
Hunter SyndromeMetabolic & Lysosomal

Hunter syndrome is an X-linked lysosomal storage disorder caused by deficiency of iduronate-2-sulfatase enzyme, leading to accumulation of glycosaminoglycans in cells and tissues. This multisystem dis...

Prevalence: 1 in 100,000 to 150,000 males; females with disease are rare
Mucopolysaccharidosis Type IMetabolic & Lysosomal

Mucopolysaccharidosis Type I (MPS I) is a lysosomal storage disorder caused by deficiency of the enzyme alpha-L-iduronidase, which breaks down glycosaminoglycans (GAGs). This results in accumulation o...

Prevalence: Approximately 1 per 100,000 live births; Hurler form is the most common phenotype

Patient Resources

Organizations and resources related to Regenxbio's rare disease focus areas

Frequently Asked Questions About Regenxbio

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