Ascletis Pharma Inc Archives

News and Trends 17 Jan 2023

Ascletis phase I COVID trial progressing

Ascletis Pharma Inc. has announced the dosing of four healthy subjects in its multiple-dose escalation phase I clinical trial of oral 3-chymotrypsin like protease (3CLpro) inhibitor ASC11 in combination with 100 mg ritonavir tablets for COVID-19. The phase I clinical trial is expected to enroll 72 healthy subjects, including 60 subjects in single-dose escalation cohorts […]

January 17, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 13 Dec 2022

Ascletis announces positive COVID-19 trial results

Ascletis Pharma Inc. has announced positive topline results from its phase I multiple ascending dose (MAD) study in healthy subjects for oral RNA-dependent RNA polymerase (RdRp) inhibitor ASC10 for COVID-19 treatment. Ascletis’ ASC10 is an innovative orally available double prodrug, which has a new and differentiated chemical structure from the single prodrug molnupiravir. After oral […]

December 13, 2022 - 3 minutesmins - By Jim Cornall

News and Trends 24 Nov 2022

FDA gives IND approval for Ascletis Covid drug

Ascletis Pharma Inc. has revealed that the U.S. Food and Drug Administration (FDA) has approved the investigational new drug (IND) application of ASC11, an oral inhibitor drug candidate targeting 3-chymotrypsin like protease (3CLpro) for Covid-19. The FDA has approved Ascletis to study the safety, tolerability and pharmacokinetics of ASC11 at various doses in healthy subjects […]

November 24, 2022 - 2 minutesmins - By Jim Cornall

News and Trends 17 Nov 2022

Ascletis announces IND approval for treatment of advanced solid tumors

Ascletis Pharma has announced the approval of the investigational new drug (IND) application by China National Medical Products Administration (NMPA). The approval is for an in-house developed oral PD-L1 small molecule inhibitor prodrug, ASC61, for the treatment of advanced solid tumors. The ASC61 phase 1 dose escalation study is ongoing in the U.S. IND approval […]

November 17, 2022 - 2 minutesmins - By Liza Laws

News and Trends 16 Nov 2022

Ascletis’ monkeypox tablet receives IND approval from the FDA

A drug to treat monkeypox from Ascletis Pharma has had its investigational new drug (IND) application approved by the U.S Food and Drug Administration (FDA). The FDA made its decision based on the available data, which was 800 mg ASC10 taken twice a day, and Ascletis can now go ahead with a phase 1b clinical […]

November 16, 2022 - 3 minutesmins - By Liza Laws

News and Trends 22 Aug 2022

Ascletis is first Chinese biotech company to get IND approvals for oral RdRp inhibitor

An investigational new drug (IND) application for a COVID-19 treatment has been approved by the China National Medical Products Administration (NMPA). The application is for ASC10, an oral inhibitor drug candidate targeting RNA-dependent RNA polymerase (RdRp) that targets the COVID-19 virus. China’s first Ascletis is China’s first biotech company to obtain IND approvals of an […]

August 22, 2022 - 2 minutesmins - By Liza Laws

News and Trends 3 Aug 2022

Ascletis announces FDA clearance of oral drug to conduct study in mild to moderate COVID-19 patients

A randomized, placebo-controlled study in mild to moderate COVID-19 patients has been approved by the US Food and Drug Administration (FDA). The Investigational New Drug (IND) application for ASC10, an oral drug candidate targeting RNA-dependent RNA polymerase (RdRp) for COVID-19 was granted to China-based Ascletis Pharma Inc today (August 3), to conduct a Phase 1b […]

August 3, 2022 - 2 minutesmins - By Liza Laws

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