obeldesivir (GS-5245) / Gilead - LARVOL DELTA

Virology Analyses from the Obeldesivir Phase 2 Study in Nonhospitalized Adults with Acute Respiratory Syncytial Virus (RSV) Infection (IDWeek 2026) - No abstract available

Clinical • P2 data • Infectious Disease • Respiratory Syncytial Virus Infections

A Phase 2 Randomized, Placebo-Controlled Study of the Safety and Efficacy of Obeldesivir to Treat Nonhospitalized Adults with Acute Respiratory Syncytial Virus (RSV) Infection (IDWeek 2026) - No abstract available

Clinical • P2 data • Infectious Disease • Respiratory Syncytial Virus Infections

Unraveling the role of PPFIA1 in cancer: a comprehensive multi-omics analysis and functional validation from pan-cancer to pancreatic cancer. (PubMed, Front Oncol) - "In pancreatic cancer, external cohorts (e.g., GSE28735, GSE52452) were used for expression and prognosis validation...PPFIA1 emerges as a pan-cancer biomarker with prognostic significance and shows an oncogenic role in PAAD, potentially associating with EMT-related malignant phenotypes. Its association with immunotherapy efficacy suggests PPFIA1 warrants further investigation as a candidate biomarker and potential functional target for precision oncology."

IO biomarker • Journal • Endometrial Cancer • Head and Neck Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • PPFIA1 • PTPRF

Identification of key metabolic enzymes involved in the activation of obeldesivir and remdesivir to the active triphosphate metabolite. (PubMed, Antimicrob Agents Chemother) - "Obeldesivir (GS-5245, ODV), an orally administered 5'-isobutyryl ester prodrug of GS-441524, has demonstrated anti-SARS-CoV-2 activity in preclinical and clinical settings. In contrast, both biochemical and cell-based assay data strongly support adenylate kinase 2 as the key enzyme for the phosphorylation of GS-441524-MP, while nucleoside diphosphate kinase NM23-H2, phosphoglycerate kinase, and pyruvate kinase likely all contribute to the formation of GS-441524-TP. This work leads to a deeper understanding of ODV and RDV metabolism, and suggests further studies are needed to identify the enzyme responsible for the activation of GS-441524 to its 5'-monophosphate."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CES1

Study of Obeldesivir as Postexposure Prophylaxis for Filovirus Diseases Virus Disease (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Gilead Sciences | N=400 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Infectious Disease

Study of Obeldesivir as Postexposure Prophylaxis for Marburg Virus Disease (clinicaltrials.gov) - P2 | N=400 | Not yet recruiting | Sponsor: Gilead Sciences | Trial completion date: Jul 2025 ➔ Oct 2025 | Initiation date: Jul 2025 ➔ Oct 2025 | Trial primary completion date: Jul 2025 ➔ Oct 2025

Trial completion date • Trial initiation date • Trial primary completion date • Infectious Disease

Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection (clinicaltrials.gov) - P2 | N=4 | Terminated | Sponsor: Gilead Sciences | N=130 ➔ 4 | Trial completion date: Apr 2026 ➔ Apr 2025 | Recruiting ➔ Terminated | Trial primary completion date: Apr 2026 ➔ Apr 2025; Study was terminated by Sponsor; the decision was not due to any safety findings.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection (clinicaltrials.gov) - P2 | N=150 | Terminated | Sponsor: Gilead Sciences | Active, not recruiting ➔ Terminated; Study was terminated by Sponsor; the decision was not due to any safety findings.

Trial termination • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Anti-SARS-CoV-2 prodrug ATV006 has broad-spectrum antiviral activity against human and animal coronaviruses. (PubMed, Acta Pharm Sin B) - "Remarkably, ATV006 successfully inhibits viral replication in mice even when administered 96 h after infection. Due to its oral bioavailability and potency against multiple coronaviruses, ATV006 has the potential to become a useful antiviral agent against SARS-CoV-2 and other circulating and emerging coronaviruses in humans and animals."

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

Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection (clinicaltrials.gov) - P2 | N=150 | Active, not recruiting | Sponsor: Gilead Sciences | Recruiting ➔ Active, not recruiting | N=240 ➔ 150

Enrollment change • Enrollment closed • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Study of Obeldesivir as Postexposure Prophylaxis for Marburg Virus Disease (clinicaltrials.gov) - P2 | N=400 | Not yet recruiting | Sponsor: Gilead Sciences | Trial completion date: Apr 2025 ➔ Jul 2025 | Initiation date: Apr 2025 ➔ Jul 2025 | Trial primary completion date: Apr 2025 ➔ Jul 2025

Trial completion date • Trial initiation date • Trial primary completion date • Infectious Disease

The oral drug obeldesivir protects nonhuman primates against lethal Ebola virus infection. (PubMed, Sci Adv) - "Obeldesivir (ODV; GS-5245) is an orally administered ester prodrug of the parent nucleoside GS-441524 that has broad spectrum antiviral activity inhibiting viral RNA-dependent RNA polymerases. For outbreak response, oral antivirals might present substantial advantages over now approved intravenous drugs, such as easy supply, storage, distribution, and administration. Furthermore, these results support the potential of ODV as an oral postexposure prophylaxis with broad spectrum activity across filoviruses."

Journal • Ebola Virus Disease • Infectious Disease • Inflammation

Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection (clinicaltrials.gov) - P2 | N=130 | Recruiting | Sponsor: Gilead Sciences | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection (clinicaltrials.gov) - P2 | N=130 | Not yet recruiting | Sponsor: Gilead Sciences

New P2 trial • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Study of Obeldesivir as Postexposure Prophylaxis for Marburg Virus Disease (clinicaltrials.gov) - P2 | N=400 | Not yet recruiting | Sponsor: Gilead Sciences

New P2 trial • Infectious Disease

Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: Gilead Sciences | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Oral pharmacokinetics and efficacy of oral phospholipid remdesivir nucleoside prodrugs against SARS-CoV-2 in mice. (PubMed, Antimicrob Agents Chemother) - "We previously synthesized 1-O-octadecyl-2-O-benzyl-sn-glyceryl-P-RVn (ODBG-P-RVn, V2043), a phospholipid prodrug of GS-441524 (remdesivir nucleoside, RVn), and demonstrated its in vivo efficacy in a SARS-CoV-2 mouse model. On a molar basis, V2043 and V2067 are substantially more active than obeldesivir/GS-5245 and molnupiravir in vivo. Together, these data support the continued development of phospholipid RVn prodrugs for the treatment of SARS-CoV-2 and other RNA viruses of clinical concern."

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

Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection (clinicaltrials.gov) - P2 | N=240 | Not yet recruiting | Sponsor: Gilead Sciences

New P2 trial • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

The oral nucleoside prodrug GS-5245 is efficacious against SARS-CoV-2 and other endemic, epidemic, and enzootic coronaviruses. (PubMed, Sci Transl Med) - "Here, we characterize the antiviral activity of GS-5245, obeldesivir (ODV), an oral prodrug of the parent nucleoside GS-441524, which targets the highly conserved viral RNA-dependent RNA polymerase (RdRp). Last, we demonstrate that a combination of GS-5245 and main protease (Mpro) inhibitor nirmatrelvir improved outcomes in vivo against SARS-CoV-2 compared with the single agents. Together, our data support the clinical evaluation of GS-5245 against coronaviruses that cause or have the potential to cause human disease."

Journal • Acute Lung Injury • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Study of Obeldesivir in Children and Adolescents With COVID-19 (clinicaltrials.gov) - P2/3 | N=3 | Terminated | Sponsor: Gilead Sciences | N=52 ➔ 3 | Trial completion date: Jun 2027 ➔ Feb 2024 | Recruiting ➔ Terminated | Trial primary completion date: Jun 2027 ➔ Feb 2024; Study was terminated by Sponsor and the decision was not due to any safety or efficacy reasons.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Infectious Disease • Novel Coronavirus Disease • Pediatrics

Oral administration of obeldesivir protects nonhuman primates against Sudan ebolavirus. (PubMed, Science) - "Obeldesivir (ODV, GS-5245) is an orally administered prodrug of the parent nucleoside of remdesivir (RDV) and is presently in phase 3 trials for COVID-19 treatment. In this work, we show that ODV and its circulating parent nucleoside metabolite, GS-441524, have similar in vitro antiviral activity against filoviruses, including Marburg virus, Ebola virus, and Sudan virus (SUDV)...Transcriptomics data show that ODV treatment delayed the onset of inflammation and correlated with antigen presentation and lymphocyte activation. Our results offer promise for the further development of ODV to control outbreaks of filovirus disease more rapidly."

Journal • Ebola Virus Disease • Infectious Disease • Inflammation • Novel Coronavirus Disease

OAKTREE: Study of Obeldesivir in Nonhospitalized Participants With COVID-19 (clinicaltrials.gov) - P3 | N=2011 | Completed | Sponsor: Gilead Sciences | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

OAKTREE: Study of Obeldesivir in Nonhospitalized Participants With COVID-19 (clinicaltrials.gov) - P3 | N=2011 | Active, not recruiting | Sponsor: Gilead Sciences | Trial completion date: Aug 2024 ➔ Jan 2024 | Trial primary completion date: Jun 2024 ➔ Nov 2023

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

OAKTREE: Study of Obeldesivir in Nonhospitalized Participants With COVID-19 (clinicaltrials.gov) - P3 | N=2011 | Active, not recruiting | Sponsor: Gilead Sciences

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

Study of Obeldesivir in Children and Adolescents With COVID-19 (clinicaltrials.gov) - P2/3 | N=52 | Recruiting | Sponsor: Gilead Sciences

Trial completion date • Trial initiation date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Pediatrics