Product Description
TAF is a novel nucleotide reverse transcriptase inhibitor for the treatment of HIV-1 infection that has efficacy similar to that of TDF and improved safety compared with TDF. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/27465879/)
Mechanisms of Action: NRT Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Bangladesh | Belgium | Brazil | Canada | Chile | China | 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 | Mexico | Netherlands | New Zealand | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Vietnam
Approved Indications: HIV Infections | Hepatitis | Hepatitis, Chronic | Hepatitis B | Hepatitis B, Chronic | HIV Infections | HIV Infections | HIV Infections
Known Adverse Events: Headache | Diarrhea | Abdominal Pain | Back Pain | Pain Unspecified | HIV Infections | Headache Disorders | Depressive Disorder | Insomnia | 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, India, Ireland, Israel, Italy, Japan, Kenya, Korea, Malaysia, Netherlands, Poland, Portugal, Puerto Rico, Romania, South Africa, Spain, Taiwan, Thailand, Turkey, Uganda, United Kingdom, United States, Unknown Location, Zimbabwe
Active Clinical Trial Count: 44
Highest Development Phases
Phase 3: Acquired Immunodeficiency Syndrome|Breastfeeding|Coinfection|Communicable Diseases|HIV Infections|Hepatitis B|Hepatitis B, Chronic|Pregnancy Outcomes|Vision, Low
Phase 2: Hepatitis A|Hepatitis D|Herpesviridae Infections|Intestinal Diseases|Kidney Diseases
Phase 1: Healthy Volunteers
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| GS-US-320-1092 | P2 |
Unknown Status |
Hepatitis B, Chronic |
2029-10-05 |
|
| 2016-000785-37 | P3 |
Active, not recruiting |
Hepatitis B, Chronic |
2029-07-22 |
|
| GS-US-412-2055 | P3 |
Unknown Status |
HIV Infections |
2027-09-29 |
|
| SimpPrEP | P3 |
Recruiting |
HIV Infections|Acquired Immunodeficiency Syndrome |
2026-10-01 |