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PTC844

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |PTC Therapeutics, Inc.|Last Updated: Aug 21, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment75

FDA Designations

No designations recorded

Clinical trial landscape

PTC844 · 1 trial · 1 indication

Phase 2 1
NCT07779616Study of PTC844 in Participants With Active Rheumatoid ArthritisRheumatoid Arthritis
NOT YET_RECRUITING75 Analytics
PHASE2NOT YET_RECRUITING
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Baseline up to Week 16
Change From Baseline to Week 2 in Dihydroorotate (DHO)
Baseline, Week 2

Secondary Endpoints

Change From Baseline to Week 12 in C-reactive Protein (CRP)
Baseline, Week 12
Change From Baseline to Week 12 in Erythrocyte Sedimentation Rate (ESR)
Baseline, Week 12
Change From Baseline in DHO Over Time
Baseline up to Week 16
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PTC844 Low DoseEXPERIMENTALParticipants will receive PTC844 at a low dose once daily (QD) orally for 12 weeks.
PTC844 High DoseEXPERIMENTALParticipants will receive PTC844 at a high dose QD orally for 12 weeks.
PlaceboPLACEBO_COMPARATORParticipants will receive placebo matching to PTC844 QD orally for 12 weeks.

Interventions

NameTypeDescription
PTC844DRUGPTC844 will be administered per schedule specified in the arm description.
PlaceboDRUGPlacebo matching to PTC844 will be administered per schedule specified in the arm description.
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo

Key Inclusion Criteria: * Historical diagnosis of RA as per the American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) diagnostic criteria. * Active RA disease with a threshold of moderate activity or higher as confirmed via DAS28-CRP (score of ≥3.2) at sc...

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Recent Changes (Last 90 Days)

LOWAug 21, 2026NCT07779616NEW_TRIAL: changed
LOWAug 21, 2026NCT07779616NEW_TRIAL: changed

Frequently asked questions about PTC844

What is PTC844 used for?

PTC844 is an investigational small molecule being developed for the treatment of rheumatoid arthritis. It is currently in Phase 2 clinical development for this indication. The drug is being studied in participants with active rheumatoid arthritis, as part of a randomized, double-blind, placebo-controlled trial.

Who makes PTC844?

PTC844 is being developed by PTC Therapeutics, Inc., a biopharmaceutical company. The company is listed on the stock exchange under the ticker symbol PTCT. PTC Therapeutics is conducting clinical trials to evaluate the safety and efficacy of PTC844 in patients with rheumatoid arthritis.

What phase is PTC844 in?

PTC844 is currently in Phase 2 clinical development. It is being evaluated in a Phase 2 study for the treatment of rheumatoid arthritis. The drug is investigational and has not yet been approved by regulatory authorities. The ongoing trial is designed to assess its effects in participants with active disease.

What clinical trials is PTC844 in?

PTC844 is being studied in a Phase 2 clinical trial with the identifier NCT07779616. This trial is titled 'Study of PTC844 in Participants With Active Rheumatoid Arthritis' and is expected to enroll 75 participants. The study is randomized, double-blind, and placebo-controlled, and is currently not yet recruiting.

Is PTC844 FDA approved?

PTC844 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for rheumatoid arthritis. The drug is being studied in a clinical trial to evaluate its safety and efficacy, but it has not yet received regulatory approval for any use.

Is PTC844 a biologic or a small molecule?

PTC844 is a small molecule, not a biologic. It is being developed as an oral or injectable therapeutic for rheumatoid arthritis. The drug is currently in Phase 2 clinical trials, where it is being tested in a placebo-controlled study to determine its potential as a treatment for this condition.