Tenofovir Disoproxil Fumarate: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Tenofovir Disoproxil Fumarate appears in the FDA drug-label database. Marketed as Tenofovir Disoproxil Fumarate.
- Boxed warning
- The FDA label for Tenofovir Disoproxil Fumarate carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
& USAGE Tenofovir disoproxil fumarate tablets are a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor. • Tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older. (1) • Tenofovir disoproxil fumarate tablets are indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older. (1) 1.1 HIV-1 Infection Tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older. The following points should be considered when initiating therapy with tenofovir disoproxil fumarate tablets for the treatment of HIV-1 infection: • Tenofovir disoproxil fumarate tablets should not be used in combination with ATRIPLA ® , BIKTARVY ® , COMPLERA ® , DESCOVY ® , GENVOYA ® , ODEFSEY ® , STRIBILD ® , TRUVADA ® , or VEMLIDY ® [See Warnings and Precautions (5.4)]. 1.2 Chronic Hepatitis B Tenofovir disoproxil fumarate tablets are indicated for the treatment o…
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates. — Gilead Sciences, Inc. | Class III (FDA: unlikely to cause harm) | Terminated | 2014-09-30 |
Phase breakdown
Conditions being studied
| Condition | Trials |
|---|---|
| Hepatitis B | 2 |
| Acute-On-Chronic Liver Failure | 1 |
| HIV | 1 |
| Healthy Volunteer | 1 |
| Integrase Strand Transfer Inhibitors | 1 |
| Metabolic Effects | 1 |
| Parkinson Disease | 1 |
| Parkinson's disease | 1 |
| Weight Gain | 1 |
Recruiting trials involving Tenofovir Disoproxil Fumarate
- Decentralization of Hepatitis B Care in Sub-Saharan Africa: a Pilot Program in Ethiopia
- Early Metabolic Effects of Antiretroviral Drugs in Healthy volUnteers: a Phase 2 Randomized Study
- Tenofovir Disoproxil Fumarate in the Treatment of Parkinson's Disease
- Three Types of Nucleotide/Nucleoside Analogues Treatment in HBV Related ACLF
Common questions
Is Tenofovir Disoproxil Fumarate FDA-approved?
Yes, marketed as Tenofovir Disoproxil Fumarate. Its FDA label carries a boxed warning.
How many recruiting trials involve Tenofovir Disoproxil Fumarate?
4 recruiting trials across 9 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.