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Emtricitabine / Tenofovir Disoproxil Oral Tablet
Emtricitabine / Tenofovir Disoproxil Oral Tablet is a Nucleoside/nucleotide reverse transcriptase inhibitor combination Small molecule drug developed by University of Chicago. It is currently FDA-approved for HIV-1 infection treatment (as part of combination antiretroviral therapy), HIV-1 pre-exposure prophylaxis (PrEP) in at-risk individuals. Also known as: Truvada, PrEP.
Emtricitabine and tenofovir disoproxil are nucleoside/nucleotide reverse transcriptase inhibitors that block HIV replication by inhibiting the enzyme responsible for converting viral RNA into DNA.
Emtricitabine and tenofovir disoproxil are nucleoside/nucleotide reverse transcriptase inhibitors that block HIV replication by inhibiting the enzyme responsible for converting viral RNA into DNA. Used for HIV-1 infection treatment (as part of combination antiretroviral therapy), HIV-1 pre-exposure prophylaxis (PrEP) in at-risk individuals.
At a glance
| Generic name | Emtricitabine / Tenofovir Disoproxil Oral Tablet |
|---|---|
| Also known as | Truvada, PrEP |
| Sponsor | University of Chicago |
| Drug class | Nucleoside/nucleotide reverse transcriptase inhibitor combination |
| Target | HIV-1 reverse transcriptase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | FDA-approved |
Mechanism of action
Emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) are antiretroviral agents that work synergistically to suppress HIV-1 replication. Both drugs inhibit reverse transcriptase, the viral enzyme essential for HIV to integrate into host cell DNA. This combination is commonly used as part of highly active antiretroviral therapy (HAART) regimens and is also approved for pre-exposure prophylaxis (PrEP) to prevent HIV acquisition in at-risk individuals.
Approved indications
- HIV-1 infection treatment (as part of combination antiretroviral therapy)
- HIV-1 pre-exposure prophylaxis (PrEP) in at-risk individuals
Common side effects
- Nausea
- Diarrhea
- Headache
- Fatigue
- Renal impairment (tenofovir-related)
- Bone density loss (tenofovir-related)
- Lactic acidosis (rare)
Key clinical trials
- A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062) (PHASE2, PHASE3)
- Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018) (PHASE3)
- ImPrEP LEN Brasil: Twice-Yearly Lenacapavir for HIV Prevention (NA)
- Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1 (PHASE2, PHASE3)
- A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010) (PHASE3)
- Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV (PHASE2, PHASE3)
- A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011) (PHASE3)
- Injectable Cabotegravir Compared to TDF/FTC For PrEP in HIV-Uninfected Men and Transgender Women Who Have Sex With Men (PHASE2, PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Emtricitabine / Tenofovir Disoproxil Oral Tablet CI brief — competitive landscape report
- Emtricitabine / Tenofovir Disoproxil Oral Tablet updates RSS · CI watch RSS
- University of Chicago portfolio CI
Frequently asked questions about Emtricitabine / Tenofovir Disoproxil Oral Tablet
What is Emtricitabine / Tenofovir Disoproxil Oral Tablet?
How does Emtricitabine / Tenofovir Disoproxil Oral Tablet work?
What is Emtricitabine / Tenofovir Disoproxil Oral Tablet used for?
Who makes Emtricitabine / Tenofovir Disoproxil Oral Tablet?
Is Emtricitabine / Tenofovir Disoproxil Oral Tablet also known as anything else?
What drug class is Emtricitabine / Tenofovir Disoproxil Oral Tablet in?
What development phase is Emtricitabine / Tenofovir Disoproxil Oral Tablet in?
What are the side effects of Emtricitabine / Tenofovir Disoproxil Oral Tablet?
What does Emtricitabine / Tenofovir Disoproxil Oral Tablet target?
Related
- Drug class: All Nucleoside/nucleotide reverse transcriptase inhibitor combination drugs
- Target: All drugs targeting HIV-1 reverse transcriptase
- Manufacturer: University of Chicago — full pipeline
- Therapeutic area: All drugs in Infectious Disease / Virology
- Indication: Drugs for HIV-1 infection treatment (as part of combination antiretroviral therapy)
- Indication: Drugs for HIV-1 pre-exposure prophylaxis (PrEP) in at-risk individuals
- Also known as: Truvada, PrEP
- Compare: Emtricitabine / Tenofovir Disoproxil Oral Tablet vs similar drugs
- Pricing: Emtricitabine / Tenofovir Disoproxil Oral Tablet cost, discount & access