remdesivir
Trade name: Veklury
Approved
Oct 22, 2020
Remdesivir, sold under the brand name Veklury, is a broad-spectrum antiviral medication developed by the biopharmaceutical company Gilead Sciences. It is administered via injection into a vein. During the COVID‑19 pandemic, remdesivir was approved or authorized for emergency use to treat COVID‑19 in numerous countries. — Wikipedia
Clinical trial activity
81 trials · 123 clinical orgs · 1 marketing orgs
Earliest trial started Jun 24, 2016 (NCT02818582)
Timeline
2010s
- Jan 1, 2016
Earliest Phase 2 Sponsor(trial)
2020s
- Jan 1, 2020
Earliest Phase 1 Sponsor(trial)
- Jan 1, 2020
Earliest Phase 3 Sponsor(trial)
- Oct 22, 2020
Gilead Sciences — Earliest FDA Approval
- Oct 22, 2020
Gilead Sciences — Marketing Organization
- Oct 22, 2020
Gilead Sciences — NDA Secondary Org
- Oct 22, 2020
Gilead Sciences — NDA Organization
Indications
Studied for
- Coronavirus Infections · Phase 3
- COVID-19 · Phase 4
- Drugs, Investigational · Phase 3
- Ebolavirus · Phase 2/Phase 3
- Filoviridae · Phase 2
- Healthy Volunteers · Phase 1
- Hemorrhagic Fever, Ebola · Phase 2
- HIV Infections · Phase 2
- Kidney Transplantation · Phase 2
- Lymphoma · Phase 2
- Marburg Virus Disease · Phase 2
- Multiple Myeloma · Phase 2
- Pneumonia · Phase 4
- Respiratory Distress Syndrome · Phase 2/Phase 3
- Respiratory Syncytial Virus Infections · Phase 2
- SARS-CoV-2 · Phase 3
- Severe Acute Respiratory Syndrome · Phase 3
- Severe acute respiratory syndrome-related coronavirus · Phase 4
Mechanism of action
Polymerase acidic protein /RNA-directed RNA polymerase catalytic subunit antagonist
- Replicase polyprotein 1abINHIBITOR
Replicase polyprotein 1ab inhibitor
Remdesivir is intracellularly converted to the pharmacologically active ingredient GS-443902 which competes with adenosine triphosphate (ATP) and is incorporated into viral RNA causing delayed chain termination.
Broad spectrum activity against filoviruses (eg, EBOV, MARV), CoVs (eg, SARS-CoV, MERS-CoV), and paramyxoviruses (eg, respiratory syncytial virus [RSV], Nipah virus [NiV], and Hendra virus). Inhibits RNA-dependent RNA polymerase from MERS-CoV. Weak inhibitor of mammalian DNA and RNA polymerases.
- RNA-directed RNA polymerase LINHIBITOR
RNA-directed RNA polymerase L inhibitor
Remdesivir is intracellularly converted to the pharmacologically active ingredient GS-443902 which competes with adenosine triphosphate (ATP) and is incorporated into viral RNA causing delayed chain termination.
Broad spectrum activity against filoviruses (eg, EBOV, MARV), CoVs (eg, SARS-CoV, MERS-CoV), and paramyxoviruses (eg, respiratory syncytial virus [RSV], Nipah virus [NiV], and Hendra virus). Inhibits RNA-dependent RNA polymerase from MERS-CoV.
Approval history
- approvedPriority reviewFast trackOct 22, 2020
Chemistry & pharmacology
SMILES
CCC(CC)COC(=O)[C@H](C)N[P@](=O)(OC[C@H]1O[C@@](C#N)(c2ccc3c(N)ncnn23)[C@H](O)[C@@H]1O)Oc1ccccc1- Mol. weight
- 602.59 g/mol
- Lipinski Ro5
- 2 violation(s)
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaRemdesivir ↗
- ChEMBLCHEMBL4863829 ↗
- ChEMBLCHEMBL4065616 ↗
Also known as
- gs-5734
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07197164 | Phase 2 | Sep 1, 2025 | FUNDACIÓN FLS DE LUCHA CONTRA EL SIDA, LAS ENFERMEDADES INFECCIOSAS Y LA PROMOCIÓN DE LA SALUD Y LA CIENCIA, Gilead Sciences |
| NCT06817889 | Phase 2 | Aug 1, 2025 | Gilead Sciences, University of Washington |
| NCT07013474 | Phase 3 | Jul 14, 2025 | Pfizer |
| NCT06873633 | Phase 2 | Jun 30, 2025 | AMS-PHPT Research Collaboration, Chiangmai University, PENTA Foundation, Universidad Complutense de Madrid |
| NCT06784973 | Phase 2 | Feb 28, 2025 | Gilead Sciences |
| NCT06792214 | Phase 4 | Jan 3, 2025 | Kingston Health Sciences Centre, Niagara Health System, Unity Health Toronto, University of Toronto |
| NCT06682234 | Phase 2 | Nov 30, 2024 | Gilead Sciences |
| NCT06585150 | Phase 2 | Oct 14, 2024 | Gilead Sciences |
| NCT05911906 | Phase 4 | Apr 1, 2024 | Aston University, Derby Hospitals NHS Foundation Trust, University of Derby, University of Exeter, University of Plymouth |
| NCT06328400 | Phase 1 | Mar 27, 2024 | Government of China |
| NCT05996744 | Phase 2/Phase 3 (Phase 3) | Jan 31, 2024 | Gilead Sciences |
| NCT06206720 | Phase 2 | Jan 31, 2024 | Government of China, Hangzhou Hospital of Traditional Chinese Medicine |
| NCT05932459 | Phase 1 | Jul 9, 2023 | Government of China |
| NCT05715528 | Phase 3 | Feb 8, 2023 | Gilead Sciences |
| NCT06860282 | Phase 1 | Dec 26, 2022 | Heronova Pharmaceuticals |
| NCT05603143 | Phase 3 | Nov 5, 2022 | Gilead Sciences |
| NCT05221138 | Phase 1 | Dec 30, 2021 | Government of China, Jiao Tong University |
| NCT05201690 | Phase 1 | Dec 14, 2021 | Government of China, Jiao Tong University |
| NCT05227768 | Phase 1 | Nov 11, 2021 | Government of China, Jiao Tong University |
| NCT05502081 | Phase 4 | Nov 1, 2021 | Tanta University |
Organizations
Research & Development (123)
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Gilead Sciences | For profit | MKTG | Oct 22, 2020 |
| Gilead Sciences | For profit | NDA2 | Oct 22, 2020 |
| Gilead Sciences | For profit | NDA | Oct 22, 2020 |