Drugs / Upamostat

Trials 4

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 23 trials
Phase 2 NCT05954286 Jan 2024 → Apr 2025 COVID-19 Henry M. Jackson Foundation for the Advancement of Military Medicine Completed No outcome recorded
Phase 2 NCT00615940 Jul 2008 → Dec 2011 Her2-receptor negative breast cancer Heidelberg Pharma AG Completed No outcome recorded
Phase 2 NCT00499265 Apr 2007 → May 2010 malignant pancreatic neoplasm Heidelberg Pharma AG Completed No outcome recorded
Phase 2/31 trial · 1 met primary
Phase 2/3 NCT04723537 Feb → Dec 2021 COVID-19 RedHill Biopharma Limited Terminated Met primary

News releases announcing trial results or a regulatory action · 12

DateIssuerRelease
2025-04-28 RedHill Biopharma Limited Regulatory RedHill Biopharma Secures Allowance of Key Chinese Patent Application for Proprietary COVID-19 Treatment, RHB-107 redhillbio.com ↗
today announced that the China National Intellectual Property Administration ("CNIPA") has formally allowed a critical use of composition-of-matter patent for RedHill's proprietary investigational compound RHB-107 (upamostat), a potential oral treatment for COVID-19 (patent application No. 202311591091.6).
2023-12-20 RedHill Biopharma Limited Results RedHill and U.S. Army Announce Opaganib and RHB-107 Combinations with Remdesivir Show Distinct Synergistic Effect Against Ebola redhillbio.com ↗
RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that its two novel, oral host-directed investigational drugs, opaganib[1] and RHB-107 (upamostat)[2], demonstrated robust synergistic effect when combined individually with remdesivir (Veklury®)[3], significantly improving viral inhibition while maintaining cell viability, in a new U.S. Army-funded and conducted Ebola virus in vitro study.
2023-12-04 RedHill Biopharma Limited Regulatory RedHill Announces New, Non-Dilutive External Funding of Entire RHB-107 COVID-19 300-Patient Phase 2 Study redhillbio.com ↗
In addition to the platform's Master Protocol, the 300-patient Phase 2 RHB-107 arm has received FDA clearance to start, with the first patient expected to be enrolled in the coming weeks.
2023-07-31 RedHill Biopharma Limited Regulatory RedHill's RHB-107 Included in U.S. Government-Supported COVID-19 Platform Trial and Cleared for Initiation by FDA redhillbio.com ↗
2023-01-03 RedHill Biopharma Limited Results RedHill Announces Publication of Positive Phase 2 Study Results with Once-Daily Oral RHB-107 in Non-Hospitalized COVID-19 redhillbio.com ↗
The study showed that RHB-107 successfully met the primary endpoint of safety and tolerability and delivered promising efficacy results, despite the small number of patients in each treatment group, including faster recovery from severe COVID-19 symptoms and 100% reduction in hospitalization due to COVID-19.
2022-10-03 RedHill Biopharma Limited Results RedHill's Oral Broad-Acting Antivirals, Opaganib and RHB-107, Inhibit Dominant Omicron Sub-Variant BA.5 redhillbio.com ↗
2022-03-01 RedHill Biopharma Limited Results RedHill Announces Positive Phase 2 Study Results with Oral RHB-107 in Non-Hospitalized COVID-19 redhillbio.com ↗
Phase 2 part of Phase 2/3 study of once-daily oral RHB-107 in symptomatic COVID-19 successfully met the study's primary endpoint showing good safety and tolerability and highly promising efficacy results
2021-09-13 RedHill Biopharma Limited Regulatory RedHill Biopharma Accelerates Ongoing U.S. Phase 2/3 COVID-19 Study of Once-Daily Oral RHB-107 in Non-Hospitalized Patients with South African Approval redhillbio.com ↗
The South African Health Products Regulatory Authority (SAHPRA) has approved the Phase 2/3 study of once-daily orally-administered RHB-107 (upamostat) for patients with symptomatic COVID-19 who do not require hospital care
2021-05-26 RedHill Biopharma Limited Regulatory RedHill Biopharma Receives Allowances for U.S. Patent Applications Covering Opaganib and RHB-107 for COVID-19 redhillbio.com ↗
today announced receipt of two Notices of Allowance from the U.S. Patent and Trademark Office (USPTO) covering opaganib1 and RHB-107 (upamostat)2 as methods for the treatment of COVID-19 caused by the SARS-CoV-2 virus.
2020-11-17 RedHill Biopharma Limited Regulatory RedHill Biopharma’s Second COVID-19 Candidate, RHB-107, Cleared by FDA for Phase 2/3 Study in Symptomatic COVID-19 Disease redhillbio.com ↗
2020-09-08 RedHill Biopharma Limited Results RedHill Biopharma’s Opaganib Demonstrates Complete Inhibition of SARS-CoV-2 redhillbio.com ↗
RedHill’s second COVID-19 drug candidate, RHB-107 (upamostat), a novel serine protease inhibitor, strongly inhibited SARS-CoV-2 viral replication in the same model, further supporting planned initiation of a Phase 2/3 U.S. outpatient study later this year
2017-10-20 RedHill Biopharma Limited Regulatory RedHill Biopharma Receives FDA Orphan Drug Designation for MESUPRON for Pancreatic Cancer redhillbio.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted MESUPRON (upamostat) Orphan Drug designation for the adjuvant treatment of pancreatic cancer.

All press releases naming this drug 14 releases

DateIssuerRelease

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 5 sources stand behind the page.

FieldValueCited text
Known as Upamostat ClinicalTrials.gov intervention name — accepted as the source's own label NCT04723537 ↗
1

NCT05954286 ↗

Known as Mesupron ChEMBL registry synonym — accepted as the source's own label CHEMBL4206119 ↗
Known as WX-671 ClinicalTrials.gov intervention name — accepted as the source's own label NCT00615940 ↗
1

NCT00499265 ↗

Known as WX-671.1 “Upamostat is available as a hydrogen sulphate salt (also designated as WX-671.1).” NCT05954286 ↗
Action Inhibit “WX-671 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.” NCT00499265 ↗
Modality Small molecule — CHEMBL4206119 ↗
Route Oral “Patients receive oral anti-uPA serine protease inhibitor WX-671” NCT00499265 ↗