Product Description
Emtricitabine (brand name: Emtriva) is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults, children, and infants. Emtricitabine is always used in combination with other HIV medicines. Emtricitabine is a nucleoside analogue and reverse transcriptase inhibitor used in combination with other agents for treatment and prevention of human immunodeficiency virus (HIV) infection and the acquired immunodeficiency syndrome (AIDS). (Sourced from: https://pubchem.ncbi.nlm.nih.gov/compound/Emtricitabine)
Mechanisms of Action: NRT Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Bulgaria | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: HIV Infections | HIV Infections | Cross Infection | HIV Infections | HIV Infections | HIV Infections | HIV Infections
Known Adverse Events: Depressive Disorder | Abdominal Pain | Dizziness | Headache | Pain Unspecified | Insomnia | Diarrhea | HIV Infections | Headache Disorders | Flatulence
Company: Gilead Sciences
Company Location: FOSTER CITY CA 94404
Company CEO: Daniel P. O’Day
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Austria, Belgium, Brazil, Canada, Chile, China, Denmark, Dominican Republic, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Kenya, Korea, Malawi, Malaysia, Netherlands, Portugal, Puerto Rico, Singapore, South Africa, Spain, Taiwan, Thailand, Turkey, Uganda, United Kingdom, United States, Unknown Location, Zimbabwe
Active Clinical Trial Count: 33
Highest Development Phases
Phase 3: Acquired Immunodeficiency Syndrome|Coinfection|Communicable Diseases|Coronavirus Infections|HIV Infections|Hepatitis B|Severe Acute Respiratory Syndrome|Vision, Low
Phase 2: Aicardi Syndrome|Biliary Cirrhosis|Cholangitis|Liver Cirrhosis
Phase 1: Healthy Volunteers|Kidney Diseases
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| RTI in AGS | P2 |
Not yet recruiting |
Aicardi Syndrome |
2029-12-01 |
|
| GS-US-412-2055 | P3 |
Unknown Status |
HIV Infections |
2027-09-29 |
|
| SimpPrEP | P3 |
Recruiting |
HIV Infections|Acquired Immunodeficiency Syndrome |
2026-10-01 |
|
| D3 | P3 |
Active, not recruiting |
HIV Infections |
2026-04-03 |