SHEN26 / Shenzhen Kexing Pharma, Shenzhen Antaiwei Biopharm - LARVOL DELTA

Mini review: SHEN26, a novel oral antiviral drug for COVID-19 treatment. (PubMed, Bioorg Med Chem Lett) - "This mini-review explores its development, including history, synthesis, preclinical evaluations, and findings from Phase I and II clinical trials. Data from each research phase further underscores SHEN26's potential as a safe and effective oral antiviral treatment for COVID-19, while also emphasizing its broader relevance in combating emerging RNA viral infections."

Journal • Review • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Efficacy and safety of SHEN26, a novel oral small molecular RdRp inhibitor for COVID-19 treatment: a multicenter, randomized, double-blinded, placebo-controlled, phase II clinical trial. (PubMed, Virol J) - "Our findings indicate a better efficacy of a high dose (400 mg) for COVID-19 treatment. These preliminary data on the efficacy and safety provide useful information and a working basis for further verification and development of SHEN26 as a novel oral small-molecule antiviral drug for treating COVID-19."

Clinical • Journal • P2 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety, tolerability, and pharmacokinetics of the novel RdRp inhibitor SHEN26 against SARS-CoV-2: a randomized, placebo-controlled, double-blind phase I study in healthy subjects. (PubMed, Expert Opin Investig Drugs) - P1 | "The trial is registered in ClinicalTrials.gov (CT. gov identifier: NCT05504746)."

Clinical • Journal • P1 data • PK/PD data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Study Evaluating SHEN26 Capsule in Patients With Mild to Moderate COVID-19 (clinicaltrials.gov) - P3 | N=1200 | Recruiting | Sponsor: Shenzhen Kexing Pharmaceutical Co., Ltd.

New P3 trial • Infectious Disease • Novel Coronavirus Disease

Study of SHEN26 Capsule in Patients With Mild to Moderate COVID-19 (clinicaltrials.gov) - P2 | N=91 | Completed | Sponsor: Shenzhen Kexing Pharmaceutical Co., Ltd. | Recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

Study of SHEN26 Capsule in Patients With Mild to Moderate COVID-19 (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Shenzhen Kexing Pharmaceutical Co., Ltd.

New P2 trial • Infectious Disease • Novel Coronavirus Disease

A Phase I Study of SHEN26 Capsule in Healthy Participants (clinicaltrials.gov) - P1 | N=86 | Completed | Sponsor: Shenzhen Kexing Pharmaceutical Co., Ltd. | Recruiting ➔ Completed

Trial completion

"Kexing Biopharm's SHEN26 takes 5' mono-isobutyric este form" (@ksrcristianchen)

A Phase I Study of SHEN26 Capsule in Healthy Participants (clinicaltrials.gov) - P1 | N=78 | Recruiting | Sponsor: Kexing Biopharm Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open

A Phase I Study of SHEN26 Capsule in Healthy Participants (clinicaltrials.gov) - P1 | N=78 | Not yet recruiting | Sponsor: Shenzhen Kexing Pharmaceutical Co., Ltd.

New P1 trial