Beraprost 314d (esuberaprost) / United Therapeutics Corp, Astellas, Kaken Pharma - LARVOL DELTA

Comparison of Pharmacokinetic Profiles of Beraprost Sustained Release in Japanese, Chinese, and Korean Healthy Adult Males. (PubMed, Clin Drug Investig) - "There were no clinically meaningful ethnic differences in the pharmacokinetics of BPS and BPS-314d following beraprost SR administration among Japanese, Chinese and Korean populations."

Clinical • Journal • PK/PD data • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Renal Disease • Respiratory Diseases

BEAT OLE: A Study With BPS-314d-MR-PAH-303 in Participants With Pulmonary Arterial Hypertension (clinicaltrials.gov) - P3; N=112; Terminated; Sponsor: Lung Biotechnology PBC; Completed ➔ Terminated; The pivotal study, BPS-314d-MR-PAH-302 (NCT01908699), failed to demonstrate efficacy.

Clinical • Trial termination • Hypertension • Pulmonary Arterial Hypertension

Pharmacology of the single isomer, esuberaprost (beraprost-314d) on pulmonary vascular tone, IP receptors and human smooth muscle proliferation in pulmonary hypertension. (PubMed, Biochem Pharmacol) - "Stereoisomer separation of beraprost has a significant effect on the pharmacology of the individual isomer, esuberaprost, identified in vitro as a highly potent prostanoid IP receptor agonist."

Journal

BPS-314d-MR-PAH-303 (BEAT OLE) (clinicaltrials.gov) - P3; N=112; Completed; Sponsor: Lung Biotechnology PBC; Active, not recruiting ➔ Completed

Clinical • Trial completion

BPS-314d-MR-PAH-303 (BEAT OLE) (clinicaltrials.gov) - P3; N=112; Active, not recruiting; Sponsor: Lung Biotechnology PBC; Trial completion date: Jun 2019 ➔ Aug 2019; Trial primary completion date: Jun 2019 ➔ Aug 2019

Clinical • Trial completion date • Trial primary completion date

Compassionate Use of Beraprost Sodium 314d Modified Release for Patients With Pulmonary Arterial Hypertension (PAH) (clinicaltrials.gov) - P2; N=3; Completed; Sponsor: Los Angeles Biomedical Research Institute; Active, not recruiting ➔ Completed; Trial completion date: Dec 2019 ➔ Jun 2019; Trial primary completion date: Dec 2019 ➔ Jun 2019

Clinical • Trial completion • Trial completion date • Trial primary completion date

Beraprost-314d Added-on to Tyvaso® (BEAT) (clinicaltrials.gov) - P3; N=240; Completed; Sponsor: Lung Biotechnology PBC; Active, not recruiting ➔ Completed

Clinical • Trial completion

BPS-314d-MR-PAH-303 (BEAT OLE) (clinicaltrials.gov) - P3; N=112; Active, not recruiting; Sponsor: Lung Biotechnology PBC; Enrolling by invitation ➔ Active, not recruiting; N=273 ➔ 112; Trial completion date: Dec 2020 ➔ Jun 2019; Trial primary completion date: Dec 2020 ➔ Jun 2019

Clinical • Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date