PTC Therapeutics

PTC Therapeutics works on 17 rare diseases tracked on Trial Friend, including Aromatic L-Amino Acid Decarboxylase Deficiency, Amyotrophic Lateral Sclerosis, Becker Muscular Dystrophy and 14 more, with 4 recruiting clinical trials and 3 FDA-approved rare disease drugs.

PTC Therapeutics develops medicines for rare metabolic and neurological diseases.

Approved products include Sephience (sepiapterin) for phenylketonuria (FDA approved July 2025) and Kebilidi (eladocagene exuparvovec), a gene therapy for AADC deficiency (FDA approved November 2024). PTC also receives royalties from Roche on Evrysdi (risdiplam) for spinal muscular atrophy.

The company's most-watched program is votoplam (PTC518), an oral pill for Huntington's disease that lowers the toxic huntingtin protein responsible for the condition. Novartis took over development, manufacturing, and commercialization in 2024.

On April 28, 2026, PTC reported positive 24-month results from the PIVOT-HD long-term extension. Patients on the higher 10 mg dose showed 52% slowing of disease progression on the standard Huntington's clinical scale (cUHDRS) compared with natural history, with 28% slowing at 5 mg. Markers of nerve damage (NfL) stayed below baseline at both doses, in contrast to the rise typically seen in untreated HD. Novartis has now started the global Phase 3 INVEST-HD trial in roughly 770 patients with early-stage disease.

Vatiquinone for Friedreich ataxia remains in development after receiving an FDA Complete Response Letter that requested more efficacy data.

On September 21, 2026, PTC completed its acquisition of ST-920 (isaralgagene civaparvovec), a one-time AAV gene therapy for Fabry disease, from Sangamo's bankruptcy auction. The rolling BLA for accelerated approval is expected to be completed in Q4 2026.

Type
Rare Disease Specialist
Ticker
PTCT
Headquarters
Warren, United States
Founded
1998
Website
ptcbio.com
4
Active Rare Disease Trials
3
Approved Rare Disease Drugs
17
Rare Diseases in Portfolio
28
Years Active

PTC Therapeutics Drug Pipeline

PTC Therapeutics has 4 active clinical trials across 3 development stages, with 4 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 PTC Therapeutics'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 PTC Therapeutics's pipeline
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1
Early Phase / Phase 11 trial
High Grade Glioma+1 more
Recruiting
1
Phase 21 trial
Recruiting
2
Phase 32 trials

PTC Therapeutics Clinical Trials (4)

Active and recruiting clinical trials sponsored by PTC 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.

Ask about PTC Therapeutics's trials
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RECRUITINGPHASE3Recently updatedNCT06302348

A Study of Sepiapterin in Participants With Phenylketonuria (PKU)

Intervention: Sepiapterin

The main purpose of this trial is to evaluate the long-term efficacy of sepiapterin on preserving neurocognitive functioning in children with PKU when treatment is initiated in early childhood.

Ages Up to 9 Years10 locations
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ACTIVE NOT RECRUITINGPHASE2Updated a few months agoNCT04903288

A Study of SmartFlow Magnetic Resonance (MR) Compatible Ventricular Cannula for Administering Eladocagene Exuparvovec to Pediatric Participants

Intervention: Eladocagene Exuparvovec

This study will have a trial phase, extension phase, and a long-term extension phase. The primary objectives of the trial phase are to assess the pharmacodynamics (PD) of eladocagene exuparvovec treatment by evaluation of homovanillic acid (HVA) levels and to assess the safety of the SmartFlow® magnetic resonance (MR) Compatible Ventricular Cannula for administering eladocagene exuparvovec to pediatric participants with aromatic L-amino acid decarboxylase (AADC) deficiency. The extension phase is designed to capture additional clinical information for eladocagene exuparvovec through study evaluations, changes in motor development, AADC-specific symptoms, and other PD measures. The long-term extension phase is designed to capture long-term safety and efficacy data from participants treated with eladocagene exuparvovec.

Ages 1 Year - 17 Years6 locations
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ACTIVE NOT RECRUITINGPHASE1No updates in a whileNCT03605550

A Phase 1b Study of PTC596 in Children With Newly Diagnosed Diffuse Intrinsic Pontine Glioma and High Grade Glioma

Intervention: PTC596, Radiotherapy

The goal of this study is to evaluate the safety of the study drug PTC596 (Unesbulin) taken in combination with radiotherapy (RT) when given to pediatric patients newly diagnosed with High-Grade Glioma (HGG) including diffuse intrinsic pontine glioma (DIPG). The main aims of the study are to: * Find the safe dose of the study drug PTC596that can be given without causing serious side effects. * Find out the amount of drug that enters blood (in all patients) and tumor (in patients who receive drug prior to a planned surgery for removal of their brain tumor) During the first cycle (6-7weeks), patients will receive drug orally twice a week in combination with daily RT. During subsequent cycles (4 weeks each), they will receive only the study drug orally twice a week. Funding Source - FDA OOPD

Ages 12 Months - 21 Years10 locations
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ACTIVE NOT RECRUITINGPHASE3No updates in a whileNCT05515536

A Study to Assess the Safety and Efficacy of Vatiquinone in Participants With Friedreich Ataxia

Intervention: Vatiquinone

The primary objective of this study is to assess the long-term safety of vatiquinone in participants with Friedreich ataxia (FA) previously exposed to vatiquinone.

Ages not specified14 locations
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PTC Therapeutics FDA-Approved Drugs (3)

Medications developed or marketed by PTC Therapeutics that have received U.S. Food and Drug Administration approval. Drug data is sourced from the openFDA database and includes brand names, generic names, approval dates, and matched rare disease indications. Where a drug treats a condition covered by Trial Friend, the disease name links directly to that disease page.

Drug NameBrand NameRare DiseasesApproval Date
DEFLAZACORT
Corticosteroid [EPC]
EMFLAZA
oral
Feb 9, 2017
SEPIAPTERINSephience
oral
Jul 28, 2025
ELADOCAGENE EXUPARVOVEC-TNEQKEBILIDI
intracerebral
——

PTC Therapeutics Trial Locations

PTC Therapeutics clinical trials are running at 40 sites in 14 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
20▼
France
4▼
Australia
3▼
Poland
2▼
Canada
2▼
Ireland
1▼
United Kingdom
1▼
Israel
1▼
Taiwan
1▼
Brazil
1▼
Germany
1▼
Italy
1▼

Rare Disease Focus Areas (17)

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

Aromatic L-Amino Acid Decarboxylase DeficiencyNeurological & Neuromuscular

AADC deficiency is a rare inherited neurological disorder that affects the brain's ability to produce dopamine and serotonin, leading to severe developmental delays, movement problems, and involuntary...

Prevalence: Extremely rare; estimated 1 in 42,000 to 1 in 190,000 births in the U.S., with higher prevalence in Asian populations
Amyotrophic Lateral SclerosisNeurological & Neuromuscular

Amyotrophic lateral sclerosis is a progressive neurodegenerative disease destroying motor neurons in the brain and spinal cord. This causes progressive weakness and paralysis of voluntary muscles whil...

Prevalence: About 5,000 new cases per year in the U.S.; approximately 16,000 Americans living with ALS at any given time
Becker Muscular DystrophyNeurological & Neuromuscular

Becker Muscular Dystrophy (BMD) is an X-linked inherited muscular dystrophy caused by mutations in the dystrophin gene that produce a partially functional dystrophin protein. BMD is milder than Duchen...

Prevalence: Approximately 1 to 5 per 100,000 males; about 1/3 to 1/2 the prevalence of Duchenne Muscular Dystrophy
Cystic FibrosisPulmonary & Respiratory

Cystic fibrosis is an autosomal recessive genetic disorder affecting the CFTR protein, which normally regulates chloride transport. Defective CFTR causes thick, sticky secretions in the lungs and dige...

Prevalence: About 30,000 people in the U.S.; 1 in 2,500 to 3,500 births among Caucasians
Diffuse Intrinsic Pontine GliomaRare Cancers

Diffuse intrinsic pontine glioma (DIPG) is an aggressive childhood brain tumor that grows in the pons, the part of the brainstem controlling breathing, swallowing, and movement. Because it weaves thro...

Prevalence: About 300 children diagnosed in the U.S. each year, most often between ages 5 and 10
Dravet SyndromeNeurological & Neuromuscular

Dravet Syndrome is a severe form of epilepsy that typically begins in infancy with prolonged seizures triggered by fever. Most cases are caused by mutations in the SCN1A gene encoding a sodium channel...

Prevalence: Approximately 1 in 16,000 to 40,000 people, accounting for 5-10% of early infantile epileptic encephalopathies

Patient Resources

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

Frequently Asked Questions About PTC Therapeutics

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