Remdesivir (GS-5734) has been evaluated across numerous clinical trials ranging from Phase 1 through Phase 4, primarily targeting COVID-19, SARS-CoV-2 pneumonia, post-acute sequelae of COVID-19, and respiratory syncytial virus infection. Supported by government, academic, and industry entities—including the National Institute of Allergy and Infectious Diseases, the University of Melbourne, Gilead Sciences, and Hoffmann-La Roche—these studies encompass recruitment statuses from actively recruiting to completed and approved for marketing. Prominent multi-center research has further established the drug's safety, antiviral efficacy, and combination regimens in hospitalized patients with severe coronavirus infections.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06551844 | RECRUITING | Dengue; Antiviral Drugs |
Oxford University Clinical Research Unit, Vietnam |
2026-04-20 | PHASE2 |
| NCT04488081 | ACTIVE_NOT_RECRUITING | COVID-19 |
QuantumLeap Healthcare Collaborative |
2020-07-31 | PHASE2 |
| NCT06817889 | RECRUITING | Hematopoietic and Lymphatic System Neoplasm; Autoimmune Disease; Respiratory Syncytial Virus Infection |
Fred Hutchinson Cancer Center |
2025-12-23 | PHASE2 |
| NCT07013474 | RECRUITING | COVID-19 Infection |
Pfizer |
2025-07-14 | PHASE3 |
| NCT04746183 | RECRUITING | Covid19 |
University of Liverpool |
2020-07-03 | PHASE1; PHASE2 |
| NCT05041907 | RECRUITING | COVID-19 |
University of Oxford |
2021-09-30 | PHASE2 |
| NCT07197164 | RECRUITING | COVID - 19; Renal Transplant; SARS CoV 2 Infection |
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia |
2025-09-01 | PHASE2 |
| NCT06610643 | NOT_YET_RECRUITING | COVID-19; SARS-CoV-2; Immunocompromised |
National Taiwan University Hospital |
2024-09-21 | |
| NCT06873633 | RECRUITING | Respiratory Syncytial Virus (RSV) |
PENTA Foundation |
2025-07-16 | PHASE2 |
| NCT07510529 | NOT_YET_RECRUITING | Healthy Participants |
Simcere Pharmaceutical Co., Ltd |
2026-04-20 | PHASE1 |
| NCT02735707 | RECRUITING | Community-acquired Pneumonia, Influenza, COVID-19 |
UMC Utrecht |
2016-04-11 | PHASE3 |
| NCT06792214 | RECRUITING | SARS CoV-2 Post-Acute Sequelae |
Mount Sinai Hospital, Canada |
2025-01-03 | PHASE4 |
| NCT05911906 | COMPLETED | SARS-CoV-2 Infection; COVID-19 |
University of Derby |
2024-10-08 | PHASE4 |
| NCT04483960 | UNKNOWN | SARS-CoV-2 Infection (COVID-19) |
University of Melbourne |
2020-07-28 | PHASE3 |
| NCT05925140 | UNKNOWN | COVID-19; Hospitalized COVID-19 Patients |
Lebanese University |
2020-03-28 | PHASE1 |
| NCT05882331 | COMPLETED | COVID-19 |
Del-Pest Central Hospital - National Institute of Hematology and Infectious Diseases |
2021-01-01 | |
| NCT04321993 | UNKNOWN | COVID-19 |
Lisa Barrett |
2020-04-17 | PHASE2 |
| NCT06860282 | COMPLETED | COVID-19; Coronavirus Pneumonia |
Heronova Pharmaceuticals |
2022-12-26 | PHASE1 |
| NCT04784559 | TERMINATED | COVID-19 Infection |
PharmaMar |
2021-06-04 | PHASE3 |
| NCT04978259 | UNKNOWN | Covid19 |
Clinical Urology and Epidemiology Working Group |
2021-07-24 | PHASE4 |
| NCT04431453 | COMPLETED | COVID-19 |
Gilead Sciences |
2020-07-21 | PHASE2; PHASE3 |
| NCT05502081 | COMPLETED | COVID-19 |
Mansoura University Hospital |
2022-09-02 | PHASE4 |
| NCT05226533 | TERMINATED | COVID-19 |
Daewoong Pharmaceutical Co. LTD. |
2022-03-31 | PHASE2 |
| NCT06729593 | COMPLETED | Covid19 |
National Institute of Allergy and Infectious Diseases (NIAID) |
2021-04-20 | PHASE3 |
| NCT04843761 | COMPLETED | Covid19 |
National Institute of Allergy and Infectious Diseases (NIAID) |
2021-04-20 | PHASE3 |
| NCT04865237 | COMPLETED | Covid19; SARS-CoV Infection; Corona Virus Infection; Coronavirus; COVID-19 |
Imperial College London |
2021-03-06 | |
| NCT04315948 | COMPLETED | Corona Virus Infection |
Institut National de la Santé Et de la Recherche Médicale, France |
2020-03-22 | PHASE3 |
| NCT04713176 | TERMINATED | Severe COVID-19 |
Daewoong Pharmaceutical Co. LTD. |
2021-02-02 | PHASE3 |
| NCT04988035 | COMPLETED | COVID-19 |
National Institute of Allergy and Infectious Diseases (NIAID) |
2021-08-03 | PHASE2 |
| NCT04583969 | COMPLETED | COVID-19 |
National Institute of Allergy and Infectious Diseases (NIAID) |
2020-10-23 | PHASE2 |
| NCT04745351 | TERMINATED | COVID-19 |
Gilead Sciences |
2021-03-31 | PHASE3 |
| NCT05780541 | TERMINATED | COVID-19 |
National Institute of Allergy and Infectious Diseases (NIAID) |
2021-09-15 | PHASE3 |
| NCT04501978 | COMPLETED | Covid19 |
National Institute of Allergy and Infectious Diseases (NIAID) |
2020-08-04 | PHASE3 |
| NCT04832880 | UNKNOWN | Covid19 |
ASST Fatebenefratelli Sacco |
2021-04-06 | PHASE3 |
| NCT04575064 | WITHDRAWN | SARS-CoV-2 Infection; COVID-19; Moderate and Severe COVID-19 |
Professor Dr. Bernd Mühlbauer |
2020-06-29 | PHASE2; PHASE3 |
| NCT05780463 | COMPLETED | COVID-19 |
National Institute of Allergy and Infectious Diseases (NIAID) |
2021-06-11 | PHASE3 |
| NCT04391309 | TERMINATED | Coronavirus Disease 2019 (COVID-19); Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) |
National Institute of Allergy and Infectious Diseases (NIAID) |
2021-04-12 | PHASE2 |
| NCT04593940 | COMPLETED | Covid19 |
Daniel Benjamin |
2020-10-15 | PHASE3 |
| NCT05780437 | COMPLETED | COVID-19 |
National Institute of Allergy and Infectious Diseases (NIAID) |
2021-02-10 | PHASE3 |
| NCT04944082 | UNKNOWN | Covid19 |
Assiut University |
2021-07-01 | PHASE4 |
| NCT05185284 | COMPLETED | COVID-19 |
Promomed, LLC |
2021-08-11 | PHASE3 |
| NCT04351724 | UNKNOWN | COVID-19 |
Medical University of Vienna |
2020-04-16 | PHASE2; PHASE3 |
| NCT04970719 | WITHDRAWN | COVID-19 Pneumonia |
Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders |
2021-07-10 | PHASE3 |
| NCT04647669 | UNKNOWN | Covid19 |
The University of The West Indies |
2021-06-01 | PHASE3 |
| NCT04610541 | UNKNOWN | SARS-CoV-2 Infection |
University of Pecs |
2020-10-12 | PHASE3 |
| NCT04583956 | COMPLETED | COVID-19 |
National Institute of Allergy and Infectious Diseases (NIAID) |
2020-10-23 | PHASE2 |
| NCT04647695 | UNKNOWN | Covid19 |
The University of Hong Kong |
2020-11-20 | PHASE2 |
| NCT04385719 | COMPLETED | Ebola; HIV/AIDS |
Makerere University |
2021-05-05 | PHASE2 |
| NCT05780281 | COMPLETED | COVID-19 |
National Institute of Allergy and Infectious Diseases (NIAID) |
2020-12-16 | PHASE3 |
| NCT05780424 | COMPLETED | COVID-19 |
National Institute of Allergy and Infectious Diseases (NIAID) |
2020-12-16 | PHASE3 |
| NCT04546581 | COMPLETED | COVID; COVID-19; SARS-CoV-2; SARS (Severe Acute Respiratory Syndrome) |
University of Minnesota |
2020-10-08 | PHASE3 |
| NCT04640168 | COMPLETED | COVID-19 |
National Institute of Allergy and Infectious Diseases (NIAID) |
2020-12-02 | PHASE3 |
| NCT04501952 | TERMINATED | COVID-19 |
Gilead Sciences |
2020-09-18 | PHASE3 |
| NCT04596839 | COMPLETED | Covid19 |
Dr. Md. Alimur Reza |
2020-09-04 | PHASE2 |
| NCT05024006 | COMPLETED | Covid19 |
University of the Philippines |
2020-04-23 | |
| NCT04694612 | UNKNOWN | Covid19 |
Nepal Health Research Council |
2021-01-01 | PHASE3 |
| NCT04738045 | UNKNOWN | Covid19 |
Ahmed Essam |
2020-11-01 | PHASE4 |
| NCT04779047 | UNKNOWN | Covid19; Pneumonia |
October 6 University |
2020-10-01 | PHASE4 |
| NCT04539262 | COMPLETED | COVID-19 |
Gilead Sciences |
2020-09-14 | PHASE1; PHASE2 |
| NCT04693026 | UNKNOWN | Covid19; Covid-19 ARDS |
M Abdur Rahim Medical College and Hospital |
2020-09-10 | PHASE3 |
| NCT04409262 | COMPLETED | COVID-19 Pneumonia |
Hoffmann-La Roche |
2020-06-16 | PHASE3 |
| NCT05780268 | COMPLETED | COVID-19 |
National Institute of Allergy and Infectious Diseases (NIAID) |
2020-08-05 | PHASE3 |
| NCT04678739 | COMPLETED | Covid19; Covid-19 ARDS |
M Abdur Rahim Medical College and Hospital |
2020-08-15 | PHASE3 |
| NCT04853901 | COMPLETED | Covid19 |
Ain Shams University |
2020-07-27 | PHASE3 |
| NCT04480333 | UNKNOWN | Covid19; Corona Virus Infection; Severe Acute Respiratory Syndrome; Severe Acute Respiratory Infection; Severe Acute Respiratory Syndrome (SARS) Pneumonia; Severe Acute Respiratory Syndrome of Upper Respiratory Tract; Neurodegeneration; Neuroinflammatory Response |
Biomed Industries, Inc. |
2020-09-15 | PHASE1 |
| NCT04492475 | COMPLETED | COVID-19 |
National Institute of Allergy and Infectious Diseases (NIAID) |
2020-08-05 | PHASE3 |
| NCT04345419 | COMPLETED | COVID |
Tanta University |
2020-06-16 | PHASE2; PHASE3 |
| NCT04410354 | TERMINATED | COVID-19 |
ViralClear Pharmaceuticals, Inc. |
2020-06-16 | PHASE2 |
| NCT04560231 | UNKNOWN | SARS-CoV Infection |
Lahore General Hospital |
2020-06-01 | EARLY_PHASE1 |
| NCT04871633 | COMPLETED | COVID-19 |
King Edward Medical University |
2020-08-01 | |
| NCT04349410 | COMPLETED | CoVid 19 Positive |
The Camelot Foundation |
2020-04-11 | PHASE2; PHASE3 |
| NCT02818582 | COMPLETED | Ebola |
National Institute of Allergy and Infectious Diseases (NIAID) |
2016-07-01 | PHASE2 |
| NCT04321616 | UNKNOWN | SARS-CoV Infection; COVID 19; Acute Respiratory Distress Syndrome ARDS |
Oslo University Hospital |
2020-03-28 | PHASE2; PHASE3 |
| NCT04401579 | COMPLETED | COVID-19 |
National Institute of Allergy and Infectious Diseases (NIAID) |
2020-05-08 | PHASE3 |
| NCT04492501 | COMPLETED | Covid19; Cytokine Release Syndrome; Critical Illness; ARDS |
UNICEF |
2020-04-01 | |
| NCT04280705 | COMPLETED | COVID-19 |
National Institute of Allergy and Infectious Diseases (NIAID) |
2020-02-21 | PHASE3 |
| NCT04292730 | COMPLETED | COVID-19 |
Gilead Sciences |
2020-03-15 | PHASE3 |
| NCT04252664 | SUSPENDED | COVID-19; SARS-CoV-2 |
Capital Medical University |
2020-02-12 | PHASE3 |
| NCT04292899 | COMPLETED | COVID-19 |
Gilead Sciences |
2020-03-06 | PHASE3 |
| NCT04257656 | TERMINATED | COVID-19; Remdesivir; SARS-CoV-2 |
Capital Medical University |
2020-02-06 | PHASE3 |
| NCT03719586 | COMPLETED | Ebola Virus |
National Institute of Allergy and Infectious Diseases (NIAID) |
2018-11-21 | PHASE2; PHASE3 |
(data from https://clinicaltrials.gov, updated on 2026-04-30)
Check the
GS-5734 (Remdesivir)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
- GS-5734 (Remdesivir) Solubility in DMSO
- GS-5734 (Remdesivir) Stock Solution
- GS-5734 (Remdesivir) Storage
- GS-5734 (Remdesivir) Stability
- GS-5734 (Remdesivir) Molecular Weight
- GS-5734 (Remdesivir) SMILES
- GS-5734 (Remdesivir) CAS Number
- GS-5734 (Remdesivir) Chemical Structure (2D and 3D)
- GS-5734 (Remdesivir) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.