DESCOVY (emtricitabine)
DESCOVY is indicated for the treatment of HIV-1 Infection.
How DESCOVY Works
Descovy contains two HIV nucleoside analog reverse transcriptase inhibitors (NRTIs): emtricitabine and tenofovir alafenamide. These agents work by inhibiting the HIV-1 reverse transcriptase enzyme, which the virus uses to transcribe its RNA into DNA. By incorporating into the viral DNA chain, these drugs cause premature chain termination, thereby preventing the virus from multiplying and infecting new cells.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2016-04-04
- Patent Cliff
- 2033
- Revenue
- $750M (Q4-2025)
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
DESCOVY Approval History
What DESCOVY Treats
1 indicationsDESCOVY is approved for 1 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- HIV-1 Infection
DESCOVY Boxed Warning
POST-TREATMENT ACUTE EXACERBATION OF HEPATITIS B and RISK OF DRUG RESISTANCE WITH USE OF DESCOVY FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION Severe acute exacerbations of hepatitis B (HBV) have been reported in individuals with HBV who have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF) and may occur with discontinuation of DESCOVY. Hepatic function should be monitored closely with both clinical and laboratory fo...
WARNING: POST-TREATMENT ACUTE EXACERBATION OF HEPATITIS B and RISK OF DRUG RESISTANCE WITH USE OF DESCOVY FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION Severe acute exacerbations of hepatitis B (HBV) have been reported in individuals with HBV who have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF) and may occur with discontinuation of DESCOVY. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in individuals with HBV who discontinue DESCOVY. If appropriate, anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.1) ] . DESCOVY used for HIV-1 PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and at least every 3 months during use. Drug-resistant HIV-1 variants have been identified with use of FTC/TDF for HIV-1 PrEP following undetected acute HIV-1 infection. Do not initiate DESCOVY for HIV-1 PrEP if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed [see Warnings and Precautions (5.2) ]. WARNING: POST-TREATMENT ACUTE EXACERBATION OF HEPATITIS B and RISK OF DRUG RESISTANCE WITH USE OF DESCOVY FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION See full prescribing information for complete boxed warning . Severe acute exacerbations of hepatitis B (HBV) have been reported in individuals with HBV who have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of DESCOVY. Hepatic function should be monitored closely in these individuals. If appropriate, anti-hepatitis B therapy may be warranted. ( 5.1 ) DESCOVY used for HIV-1 PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and at least every 3 months during use. Drug-resistant HIV-1 variants have
DESCOVY Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to DESCOVY
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
16 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05979311 VOGUE | 219816 | Ph 3 | active not recruiting | A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy |
| NCT05528653 e-PrEP | IN-US-412-6419 | Ph 4 | completed | Telehealth as a Modality to Increase the Uptake of PrEP Services in Black and Latino: "e-PrEP" |
| NCT01400412 results posted | ACTG A5303 1U01AI068636 | Ph 2 | completed | Bone, Immunologic, and Virologic Effects of a Antiretroviral Regimen |
| NCT00799864 results posted | CR002677 TMC278-TiDP38-C213, 2008-001696-30 | Ph 2 | completed | A Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of Rilpivirine (TMC278) in Human Immunodeficiency Virus Infected Adolescents and Children Aged Greater Than or Equal to 6 Years |
| NCT02486133 Dualis | DUA-1463-SPI-0320-I | Ph 3 | completed | Dual Therapy With Boosted Darunavir + Dolutegravir |
| NCT02475915 | SEARCH 019 | Ph 1, Ph 2 | completed | Efficacy of VHM After Treatment Interruption in Subjects Initiating ART During Acute HIV Infection |
| NCT04097925 results posted | DORAGEN 2018-003921-27 | Ph 2 | completed | Doravirine Concentrations and Antiviral Activity in Genital Fluids in HIV-1 Infected Individuals |
| NCT04079452 results posted | DORACeNeS 2018-003915-24 | Ph 3 | completed | Doravirine Concentrations and Antiviral Activity in Cerebrospinal Fluid in HIV-1 Infected Individuals |
| NCT01505114 results posted | HPTN 069/A5305 (NEXT Prep) 11789, HPTN 069/A5305 | Ph 2 | completed | Evaluating the Safety and Tolerability of Antiretroviral Drug Regimens Used as Pre-Exposure Prophylaxis to Prevent HIV Infection in At-Risk Men Who Have Sex With Men and in At-Risk Women |
| NCT01709084 SALIF results posted | CR100875 TMC278IFD3002 | Ph 3 | completed | A Clinical Trial Comparing the Efficacy of Tenofovir Disoproxil Fumarate/Emtricitabine/Rilpivirine (TDF/FTC/RPV) Versus TDF/FTC/Efavirenz (TDF/FTC/EFV) in Patients With Undetectable Plasma HIV-1 RNA on Current First-line Treatment |
| NCT04477096 | HS-10234-108 | Ph 1 | completed | Evaluation of Drug Interaction Between HS-10234 and Emtriccitabine |
| NCT01803074 results posted | 206739 2012-004124-38, AI468-002 | Ph 2 | completed | Study to Evaluate a HIV Drug for the Treatment of HIV Infection |
| NCT01335620 results posted | RTG_60 2010-022907-23 | Ph 4 | completed | The Safety, Pharmacokinetic Profile and Efficacy of Raltegravir in HIV-infected Patients at Least 60 Years of Age |
| NCT02116660 RANIA results posted | 0518-284 2013-001637-40, MK-0518-284 | Ph 2 | terminated | Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284) |
| NCT02904369 | A15-137 | Ph 1 | completed | PK and PD Study of Oral F/TAF for HIV Prevention |
| NCT00869960 results posted | F080428014 1K23AI074390-01A2 | Ph 4 | completed | Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in Healthy Women |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DESCOVY FDA Label Details
Indications & Usage
FDA Label (PDF)DESCOVY is indicated for the treatment of HIV-1 Infection.
WARNING: POST-TREATMENT ACUTE EXACERBATION OF HEPATITIS B and RISK OF DRUG RESISTANCE WITH USE OF DESCOVY FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION Severe acute exacerbations of hepatitis B (HBV) have been reported in individuals with HBV who have discontinued pr...
DESCOVY Patents & Exclusivity
Patents (4 active)
Exclusivity
Pro Intelligence Preview
Deep insights for DESCOVY
Revenue Insights
- • Q4-2025: $750M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2033
- • 24 active patents
Trial Analysis
- • 4 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment