Remdesivir

Remdesivir is an antiviral drug with activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) [see Microbiology (12.4) ].

• VEKLURY is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (birth to less than 18 years of age weighing at least 1.5 kg) who are [see Clinical Studies (14) ] : Hospitalized, or Not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death. VEKLURY is a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleotide analog RNA polymerase inhibitor indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (birth to less than 18 years of age weighing at least 1.5 kg) who are: Hospitalized, or Not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death.

• VEKLURY is contraindicated in patients with a history of clinically significant hypersensitivity reactions to VEKLURY or any components of the product [see Warnings and Precautions (5.1) ]. VEKLURY is contraindicated in patients with a history of clinically significant hypersensitivity reactions to VEKLURY or any components of the product.contraindicated

Testing: In all patients, before starting VEKLURY and during treatment as clinically appropriate, perform hepatic laboratory testing. Assess prothrombin time before starting VEKLURY and monitor as clinically appropriate. ( 2.2 ) Recommended dosage: Adults and pediatric patients weighing at least 40 kg: a single loading dose of VEKLURY 200 mg on Day 1 followed by once-daily maintenance doses of VEKLURY 100 mg from Day 2 via intravenous infusion. ( 2.3 ) Pediatric patients (birth to less than 18 years of age) weighing 1.5 kg to less than 40 kg: Recommended dosage is based on weight. Refer to Table 1 of the full prescribing information for specific dosing guidelines based on body weight. ( 2.3 ) Hospitalized patients: The treatment course of VEKLURY should be initiated as soon as possible after diagnosis of symptomatic COVID-19 has been made. ( 2.3 ) For hospitalized patients requiring invasive mechanical ventilation and/or ECMO, the recommended total treatment duration is 10 days. ( 2.3 ) For hospitalized patients not requiring invasive mechanical ventilation and/or ECMO, the recommended treatment duration is 5 days. If a patient does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days for a total treatment duration of up to 10 days. ( 2.3 ) Non-hospitalized patients: The treatment course of VEKLURY should be initiated as soon as possible after diagnosis of symptomatic COVID-19 has been made and within 7 days of symptom onset.

Hypersensitivity including infusion-related and anaphylactic reactions: Hypersensitivity reactions have been observed during and following administration of VEKLURY. Slower infusion rates, with a maximum infusion time of up to 120 minutes, can be considered to potentially prevent signs and symptoms of hypersensitivity. Monitor patients during infusion and observe patients for at least one hour after infusion is complete for signs and symptoms of hypersensitivity as clinically appropriate. If signs and symptoms of a clinically significant hypersensitivity reaction occur, immediately discontinue administration of VEKLURY and initiate appropriate treatment. ( 5.1 ) Increased risk of transaminase elevations: Transaminase elevations have been observed in healthy volunteers and have also been reported in patients with COVID-19 who received VEKLURY. Perform hepatic laboratory testing in all patients before starting VEKLURY and while receiving VEKLURY as clinically appropriate. Consider discontinuing VEKLURY if ALT levels increase to greater than 10 times the upper limit of normal. Discontinue VEKLURY if ALT elevation is accompanied by signs or symptoms of liver inflammation. ( 5.2 ) Risk of reduced antiviral activity when coadministered with chloroquine phosphate or hydroxychloroquine sulfate: Coadministration of VEKLURY and chloroquine phosphate or hydroxychloroquine sulfate is not recommended based on data from cell culture experiments demonstrating a potential antagonistic effect of chloroquine on the intracellular metabolic activation and antiviral activity of VEKLURY.

The following adverse reactions are discussed in other sections of the labeling: Hypersensitivity Including Infusion-related and Anaphylactic Reactions [see Warnings and Precautions (5.1) ] Increased Risk of Transaminase Elevations [see Warnings and Precautions (5.2) ] The most common adverse reactions (incidence greater than or equal to 5%, all grades) observed with treatment with VEKLURY are nausea, ALT increased, and AST increased. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trials in Adult Subjects The safety of VEKLURY is based on data from four Phase 3 studies in 1,476 hospitalized adult subjects with COVID-19, one Phase 3 study in 279 non-hospitalized adult and pediatric subjects (12 years of age and older weighing at least 40 kg) with mild-to-moderate COVID-19, four Phase 1 studies in 131 healthy adults, and from patients with COVID-19 who received VEKLURY under the Emergency Use Authorization or in a compassionate use program.

8.1 Pregnancy Risk Summary Available data from a clinical trial (IMPAACT 2032), published reports, the COVID-PR pregnancy exposure registry, and compassionate use of remdesivir in pregnant individuals have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes following exposure in the second and third trimester. However, there are insufficient pregnancy data available to evaluate the risk of remdesivir exposure during the first trimester. A study evaluating the pharmacokinetics of remdesivir during pregnancy demonstrated no clinically relevant differences between pregnant and non-pregnant individuals. No dose adjustments are recommended in patients who receive VEKLURY during pregnancy (see Data ) and [see Clinical Pharmacology (12.3) ] . In nonclinical reproductive toxicity studies, remdesivir demonstrated no adverse effect on embryo-fetal development when administered to pregnant animals at systemic exposures (AUC) of the predominant circulating metabolite of remdesivir (GS-441524) that were 4 times (rats and rabbits) the exposure in humans at the recommended human dose (RHD) (see Data ). There are maternal and fetal risks associated with untreated COVID-19 in pregnancy (see Clinical Considerations ). The background risk of major birth defects and miscarriage for the indicated population is unknown.

Metabolism

The pharmacokinetic (PK) properties of remdesivir and metabolites are provided in Table 12. The multiple dose PK parameters of remdesivir and metabolites in adults with COVID-19 are provided in Table 13.

There is no human experience of acute overdosage with VEKLURY. Treatment of overdose with VEKLURY should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. There is no specific antidote for overdose with VEKLURY.

• Oct 22, 2020NDANDA214787Gilead Sciences Inc

1. 1Off Label Use2,22917%
2. 2Alanine Aminotransferase Increased9347.1%
3. 3Covid-199076.9%
4. 4Drug Ineffective7635.8%
5. 5Death7565.7%
6. 6Bradycardia6524.9%
7. 7Aspartate Aminotransferase Increased6284.8%
8. 8Acute Kidney Injury6244.7%
9. 9Respiratory Failure5264.0%
10. 10Covid-19 Pneumonia4863.7%
11. 11Liver Function Test Increased4203.2%
12. 12Condition Aggravated3792.9%
13. 13Drug Ineffective For Unapproved Indication3282.5%
14. 14Pneumonia3282.5%
15. 15Blood Creatinine Increased3212.4%

The 10 most recently updated of 132 ClinicalTrials.gov registrations naming Remdesivir as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised
  Recruiting · Phase 3 · Interventional · 300 enrolled · Pfizer
  NCT07013474updated 2026-06-05
• Remdesivir for the Treatment of Upper Respiratory Tract Infection Due to RSV in Immunocompromised Individuals
  Recruiting · Phase 2 · Interventional · 60 enrolled · Fred Hutchinson Cancer Center
  NCT06817889updated 2026-06-03
• AGILE (Early Phase Platform Trial for COVID-19)
  Recruiting · Phase 1 · Phase 2 · Interventional · 600 enrolled · University of Liverpool
  NCT04746183updated 2026-06-01
• Trial of Treatments for COVID-19 in Hospitalized Adults
  Completed · Phase 3 · Interventional · 1,552 enrolled · Institut National de la Santé Et de la Recherche Médicale, France
  NCT04315948updated 2026-05-20
• Adaptive Dengue Antiviral Platform Trial
  Recruiting · Phase 2 · Interventional · 500 enrolled · Oxford University Clinical Research Unit, Vietnam
  NCT06551844updated 2026-04-30
• Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
  Recruiting · Observational · 1,600 enrolled · Duke University
  NCT03511118updated 2026-04-24
• Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
  Recruiting · Observational · 5,000 enrolled · Duke University
  NCT04278404updated 2026-04-06
• A Crossover Study to Evaluate the Relative Bioavailability of Two Formulations of Deuterated Remdesivir Hydrobromide for Oral Suspension in Healthy Chinese Adults
  Not yet recruiting · Phase 1 · Interventional · 48 enrolled · Simcere Pharmaceutical Co., Ltd
  NCT07510529updated 2026-04-03
• I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients
  Active not recruiting · Phase 2 · Interventional · 1,500 enrolled · QuantumLeap Healthcare Collaborative
  NCT04488081updated 2026-03-16
• Multicenter, Retrospective Study of the Effects of Remdesivir in the Treatment of Severe Covid-19 Infections
  Completed · Observational · 84 enrolled · Assistance Publique - Hôpitaux de Paris
  NCT04365725updated 2026-03-09

Frequently asked questions

How does Remdesivir work?

Remdesivir is an antiviral drug with activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) [see Microbiology (12.4) ].

What is Remdesivir used for?

According to FDA labeling, Remdesivir carries indications including: VEKLURY is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (birth to less than 18 years of age weighing at least 1.5 kg) who are [see Clinical Studies (14) ] : Hospitalized, or Not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death. VEKLURY is a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleotide analog RNA polymerase inhibitor indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (birth to less than 18 years of age weighing at least 1.5 kg) who are: Hospitalized, or Not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Remdesivir?

Remdesivir is classified as Nucleosides and nucleotides excl. reverse transcriptase inhibitors, SARS-CoV-2 Nucleotide Analog RNA Polymerase Inhibitor, RNA Replicase Inhibitors, Decreased RNA Replication.

What are the brand names for Remdesivir?

Remdesivir is marketed under brand names including Veklury.

What are the contraindications for Remdesivir?

Remdesivir labeling lists contraindications including: VEKLURY is contraindicated in patients with a history of clinically significant hypersensitivity reactions to VEKLURY or any components of the product [see Warnings and Precautions (5.1) ]. VEKLURY is contraindicated in patients with a history of clinically significant hypersensitivity reactions to VEKLURY or any components of the product.. Always consult the full prescribing information and a clinician.