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

Beraprost Attenuates Starvation-Induced Apoptosis and Protects Feline Endothelial Cells. (PubMed, Vet Med Sci) - "Beraprost effectively attenuates starvation-induced apoptosis-associated events in cultured immortalized feline aortic endothelial cells, inhibits caspase-3/7 activity, and modulates Bax expression. These findings suggest a potential hypothesized mechanism that may contribute to the clinical efficacy of beraprost observed in feline CKD, although further validation using renal endothelial cells and in vivo models is required."

IO biomarker • Journal • Nephrology • Renal Disease • BAX • BCL2 • CASP3 • CASP7

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