Zevra Therapeutics

Zevra Therapeutics works on 4 rare diseases tracked on Trial Friend, including Niemann-Pick Disease Type C, Niemann-Pick Disease, Urea Cycle Disorders and 1 more, with 2 recruiting clinical trials and 2 FDA-approved rare disease drugs.

Zevra Therapeutics is a Florida-based rare disease company, renamed from KemPharm in February 2023 to mark its pivot to rare and ultra-rare conditions. Miplyffa (arimoclomol), approved in September 2024, was the first FDA-approved treatment for Niemann-Pick disease type C. Through its 2023 acquisition of Acer Therapeutics, Zevra also markets Olpruva (sodium phenylbutyrate) for certain urea cycle disorders and is running the Phase 3 DiSCOVER trial of celiprolol (Edsivo) for vascular Ehlers-Danlos syndrome under a Special Protocol Assessment with the FDA.

Type
Rare Disease Specialist
Ticker
ZVRA
Headquarters
Celebration, United States
Founded
2006
Website
zevra.com
2
Active Rare Disease Trials
2
Approved Rare Disease Drugs
4
Rare Diseases in Portfolio
20
Years Active

Zevra Therapeutics Drug Pipeline

Zevra Therapeutics has 2 active clinical trials across 2 development stages, with 2 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 Zevra 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 Zevra Therapeutics's pipeline
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1
Phase 21 trial
Medium-chain Acyl-CoA Dehydrogenase Deficiency
Recruiting
1
Phase 31 trial

Zevra Therapeutics Clinical Trials (2)

Active and recruiting clinical trials sponsored by Zevra 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 Zevra Therapeutics's trials
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RECRUITINGPHASE2Updated a few months agoNCT06773026

Study of Sodium Phenylbutyrate (ACER-001) for the Treatment of Pediatric and Adults Patients With Medium Chain Acyl-CoA Dehydrogenase Deficiency (MCADD)

Intervention: Sodium phenylbutyrate

Medium-chain Acyl-CoA Dehydrogenase Deficiency

This is a medical research study to test a medication in patients 4 years of age and older with a disease called medium-chain acyl-CoA dehydrogenase deficiency (MCADD) caused by the common ACADM c.985 A\>G (K304E) mutation. The medication is sodium phenylbutyrate (ACER-001), which is currently FDA approved for the treatment of Urea Cyle Disorders. Previous research suggests that sodium phenylbutyrate may also be effective in the treatment MCADD. This study will investigate the safety and efficacy (how well it works) of sodium phenylbutyrate in patients with MCADD.

Ages 4 Years+1 location
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RECRUITINGPHASE3Hasn't posted an update in over a yearNCT05432466

Clinical Trial to Compare the Efficacy of Celiprolol to Placebo in Patients With Vascular Ehlers-Danlos Syndrome

Intervention: ACER-002 (celiprolol) 200 mg BID, Placebo BID

This is a prospective, Phase 3, randomized, double-blind, placebo-controlled efficacy study to evaluate celiprolol in patients genetically confirmed as COL3A1-positive vEDS using a decentralized clinical trial design.

Ages 15 Years - 64 Years1 location
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Zevra Therapeutics FDA-Approved Drugs (2)

Medications developed or marketed by Zevra 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
BENZHYDROCODONE AND ACETAMINOPHENAPADAZ
oral
—Feb 23, 2018
ARIMOCLOMOL CITRATEMIPLYFFA
oral
Sep 20, 2024

Zevra Therapeutics Trial Locations

Zevra Therapeutics clinical trials are running at 2 sites in 1 country. 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
2▼

Rare Disease Focus Areas (4)

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

Patient Resources

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

Frequently Asked Questions About Zevra Therapeutics

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