Olpruva

(phenylbutyrate)

Small molecule

HHorizon Therapeutics Ireland DAC

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Clinical

Trials by Indication[1]

Inclusion Body Myositis1 trial

Safety and Tolerability of Phenylbutyrate in Inclusion Body Myositis

Completed·UUniversity of Kansas Medical Center·Phase 1·NCT04421677·10 enrolled

Refractory Malignancy1 trial

Phase I and Pharmacokinetic Trial of Phenylbutyrate Given as a Continuous Infusion in Pediatric Patients With Refractory Malignancy

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00001565·35 enrolled

Brain Tumors1 trial

Phenylbutyrate to Treat Children With Progressive or Recurrent Brain Tumors

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00006450·120 enrolled

APL1 trial

Phenylbutyrate Therapy for Maple Syrup Urine Disease

Completed·BBrendan Lee·Phase 2/3·NCT01529060·20 enrolled

Regulatory

FDA Approval Timeline[3]

Apr 30, 1996

BUPHENYL

NDA NDA020573

May 13, 1996

BUPHENYL

NDA NDA020572

Jun 17, 2022

PHEBURANE

NDA NDA216513

Oct 10, 2025

OLPRUVA

NDA NDA214860

Sources

References

[1]
ClinicalTrials.gov — 4 trial records for phenylbutyrate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — phenylbutyrate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA214860). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Olpruva. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Horizon Therapeutics Ireland DAC company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: HHorizon Therapeutics Ireland DAC

Patent Landscape[4]

Patent Cliff

Oct 17, 2036

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11202767Oct 17, 2036

11433041Oct 17, 2036

11154521Oct 17, 2036