tenofovir
Trade name: viread
Approved
Oct 26, 2001
CMX157 is a lipid (1-0-hexadecyloxypropyl) conjugate of the acyclic nucleotide analog tenofovir (TFV) with activity against both wild-type and antiretroviral drug-resistant HIV strains, including multidrug nucleoside/nucleotide analog-resistant viruses. CMX157 was designed to mimic lysophosphatidylcholine to take advantage of natural lipid uptake pathways and to achieve high intracellular concentrations of the active antiviral, with the aim of increasing the effectiveness of TFV against wild-type and mutant HIV. CMX157 demonstrated potential to effectively suppress replication of multiNRTI-resistant (MNR) HIV that cannot be treated with any currently available NRTIs, including TDF. It is in phase II clinical trial for HIV infections in USA and phase Ib portion of the phase I/II trial for Hepatitis B in Thailand (PO). — NCATS
Clinical trial activity
835 trials · 526 clinical orgs · 27 marketing orgs
Earliest trial started Nov 2, 1999 (NCT00002180)
Timeline
1990s
- Mar 19, 1997
Gilead Sciences — IND Organization
- Mar 19, 1997
Gilead Sciences — IND Organization
- Jan 1, 1999
Gilead Sciences — Earliest Phase 1 Sponsor(trial)
- Jan 1, 1999
Gilead Sciences — Earliest Phase 2 Sponsor(trial)
2000s
- Jan 1, 2000
Gilead Sciences — Earliest Phase 3 Sponsor(trial)
- Oct 26, 2001
Gilead Sciences — Earliest FDA Approval
- Oct 26, 2001
Gilead Sciences — NDA Organization
- Nov 30, 2007
Matrix Laboratories Limited — Marketing Organization
- Nov 5, 2009
Hetero Labs Ltd — NDA Secondary Org
2010s
- Mar 4, 2011
Cipla — NDA Secondary Org
- Sep 8, 2011
Mylan — NDA Secondary Org
- Nov 8, 2012
Macleods Pharmaceuticals, Ltd — Marketing Organization
- Nov 8, 2012
Neogen — NDA Secondary Org
- May 17, 2013
Ranbaxy — Marketing Organization
- May 17, 2013
Ranbaxy — NDA Secondary Org
- Jul 31, 2013
Strides Pharma Science — Marketing Organization
- Oct 18, 2013
Aurobindo Pharma — Marketing Organization
- Oct 18, 2013
Aurobindo Pharma — NDA Secondary Org
- Feb 26, 2014
Cipla — Marketing Organization
- Sep 12, 2014
Mylan — Marketing Organization
- Feb 6, 2015
Lupin — Marketing Organization
- Mar 18, 2015
Teva — Marketing Organization
- Dec 29, 2016
Pharmacare PLC, Palestine — Marketing Organization
- Jun 30, 2017
Hetero Labs Ltd — Marketing Organization
- Jan 26, 2018
Neogen — Marketing Organization
- Feb 26, 2018
CASI Pharmaceuticals, Inc. — Marketing Organization
- Mar 2, 2018
Qilu Pharmaceutical Co., Ltd. — Marketing Organization
- Apr 9, 2018
PHARMOBEDIENT — Marketing Organization
- Jul 31, 2018
Apotex — Marketing Organization
- Jul 31, 2018
Chartwell Pharmaceuticals — Marketing Organization
- Aug 22, 2018
Amneal Pharmaceuticals — Marketing Organization
- Aug 30, 2018
Merck — Marketing Organization
- Aug 30, 2018
Merck — NDA Secondary Org
- Nov 16, 2018
Celltrion — Marketing Organization
- Nov 16, 2018
Chartwell Pharmaceuticals — NDA Secondary Org
- Feb 1, 2019
Laurus Labs Ltd — Marketing Organization
- Feb 1, 2019
Laurus Labs Ltd — NDA Secondary Org
2020s
- Feb 28, 2020
Zydus Discovery DMCC — Marketing Organization
- Oct 6, 2020
Desano — NDA Secondary Org
- Jun 25, 2021
Lupin — NDA Secondary Org
- Mar 2, 2023
Reyoung Pharma Co Ltd — Marketing Organization
- Jul 12, 2023
Emcure — NDA Secondary Org
- Dec 18, 2025
Micro Labs Ltd India — Marketing Organization
Indications
Studied for
- Acquired Immunodeficiency Syndrome · Phase 4
- Acute-On-Chronic Liver Failure · Phase 4
- Aicardi Syndrome · Phase 1/Phase 2
- AIDS-Related Opportunistic Infections · Phase 4
- Alcohol-Induced Disorders · Phase 4
- Alveolar Bone Loss · Phase 4
- Amphetamine-Related Disorders · Phase 2
- Analgesics, Opioid · Phase 4
- Anesthesia · Phase 4
- Anti-Infective Agents · Phase 1
- Anti-Retroviral Agents · Phase 2
- Antiretroviral Therapy, Highly Active · Phase 4
- Art · Phase 3
- Atazanavir Sulfate · Phase 1
- Atherosclerosis · Phase 2
- Behavior and Behavior Mechanisms · Phase 1/Phase 2
- Body Weight Changes · Phase 4
- Bone Diseases · Phase 4
- Bone Diseases, Metabolic · Phase 4
- Breast Feeding · Phase 3
- Carcinoma, Hepatocellular · Phase 4
- Cardiovascular Diseases · Phase 4
- Central Nervous System · Phase 2
- Central Nervous System Diseases · Phase 4
- Chlamydia · Phase 3
- Cognition Disorders · Phase 4
- Communicable Diseases · Phase 2
- Congenital Abnormalities · Phase 4
- Contraception · Phase 2
- Contraception Behavior · Phase 1
- Coronavirus Infections · Phase 3
- COVID-19 · Phase 3
- Dementia · Phase 4
- Depression · Phase 4
- Drug Evaluation · Phase 1/Phase 2
- Drug Interactions · Phase 1
- Drug Misuse · Early Phase 1
- Drug-Related Side Effects and Adverse Reactions · Phase 4
- Drugs, Investigational · Phase 4
- Dyslipidemias · Phase 4
- Epstein-Barr Virus Infections · Phase 1/Phase 2
- Estrogens · Phase 4
- Fasting · Phase 3
- Fatty Liver · Phase 4
- Fibrosis · Phase 4
- Gender Dysphoria · Phase 1
- Gender Identity · Phase 1/Phase 2
- Gonorrhea · Phase 3
- Healthy Volunteers · Phase 4
- Hematologic Neoplasms · Phase 4
- Hepacivirus · Phase 1
- Hepatitis · Phase 1
- Hepatitis B · Phase 2
- Hepatitis B virus · Phase 4
- Hepatitis C · Phase 4
- Hepatitis C, Chronic · Phase 4
- Hepatitis, Chronic · Phase 4
- Hepatitis D · Phase 2
- Hepatitis D, Chronic · Phase 3
- Herpes Genitalis · Phase 4
- HIV · Phase 4
- HIV-1 · Phase 4
- HIV-Associated Lipodystrophy Syndrome · Phase 4
- HIV Seronegativity · Phase 2/Phase 3
- HIV Seropositivity · Phase 2
- Hormones · Phase 4
- Hypertension · Phase 1
- Immune Checkpoint Inhibitors · Phase 1/Phase 2
- Infectious Disease Transmission, Vertical · Phase 4
- Insulin Resistance · Phase 1
- Kidney Diseases · Phase 4
- Kidney Failure, Chronic · Phase 1
- Lenalidomide · Phase 1/Phase 2
- Leukoencephalopathy, Progressive Multifocal · Phase 2
- Lipodystrophy · Phase 2
- Liver Cirrhosis · Phase 4
- Liver Cirrhosis, Biliary · Phase 2
- Liver Diseases · Phase 1
- Lung Diseases · Phase 1
- Lung Transplantation · Phase 2
- Lymphoma · Phase 3
- Lymphoma, B-Cell · Phase 3
- Lymphoma, Non-Hodgkin · Phase 4
- Malaria · Phase 3
- Medication Adherence · Phase 4
- Menopause · Phase 4
- Metabolic Diseases · Phase 4
- Metabolic Syndrome · Phase 3
- Minority Health · Phase 3
- Mitochondrial Diseases · Phase 1/Phase 2
- Multiple Sclerosis · Phase 2
- Neoplasms · Phase 4
- Nutrition Disorders · Phase 2
- Obesity · Phase 4
- Opioid-Related Disorders · Phase 4
- Organ Transplantation · Phase 4
- Osteoporosis · Phase 4
- Overweight · Phase 3
- Parasitic Diseases · Phase 1/Phase 2
- Parkinson Disease · Phase 1
- Patient Acceptance of Health Care · Phase 2
- Patient Compliance · Phase 4
- Persistent Infection · Phase 4
- Pharmacokinetics · Phase 1/Phase 2
- Pre-Exposure Prophylaxis · Phase 4
- Pregnancy · Phase 4
- Proteinuria · Phase 4
- Quality of Life · Phase 4
- Rectum · Phase 1
- Renal Insufficiency · Phase 4
- Respiratory Tract Infections · Phase 1/Phase 2
- Risk Factors · Phase 1
- Risk Reduction Behavior · Phase 4
- Risk-Taking · Phase 4
- Safety · Phase 1/Phase 2
- Sarcoma, Kaposi · Phase 4
- SARS-CoV-2 · Phase 2/Phase 3
- Sexual Behavior · Phase 4
- Sexually Transmitted Diseases · Phase 4
- Sleep Disorders, Intrinsic · Phase 4
- Sleep Wake Disorders · Phase 4
- Substance Abuse, Oral · Phase 2
- Substance-Related Disorders · Phase 4
- Syphilis · Phase 4
- Tenofovir · Phase 4
- Therapeutics · Phase 1
- Transgender Persons · Phase 4
- Tuberculosis · Phase 4
- Tuberculosis, Multidrug-Resistant · Phase 1
- Tuberculosis, Pulmonary · Phase 1
- Vascular Diseases · Phase 2
- Viremia · Phase 4
- Weight Gain · Phase 4
- Weight Loss · Phase 4
Mechanism of action
Q72547 inhibitor
- DNA polymerase/reverse transcriptaseINHIBITOR
DNA polymerase/reverse transcriptase inhibitor
Combination products
atripla
with efavirenz, emtricitabine
Also known as emtricitabine; tenofovir disoproxil fumarate; efavirenz
complera
with emtricitabine, rilpivirine
delstrigo
with doravirine, lamivudine
Also known as doravirine/lamivudine/tenofovir disoproxil fumarate 100 mg-300 mg-300 mg oral tablet [delstrigo]
lamivudine/tenofovir disoproxil fumarate fdc tabs
with lamivudine
Also known as cimduo, temixys
stribil
with emtricitabine, cobicistat, elvitegravir
Also known as cobicistat, elvitegravir, emtricitabine, and tenofovir disoproxil fumarate
symfi lo
with efavirenz, lamivudine
Also known as efavirenz, lamivudine,and tenofovir disoproxil fumarate, symfi
truvada
with emtricitabine
Also known as emtricitabine and tenofovir disoproxil fumarate, emtricitabine/tenofovir disoproxil fumarate 200 mg-245 mg oral tablet [truvada], immediate intervention arm truvada in brazil, tenofovir (300mg)/emtricitabine(200mg) [truvada®], tenofovir disoproxil fumarate; emtricitabine, tenofovir disoproxyl fumarate 300 mg plus emtricitabine 200 mg oral tablet
Approval history
- approvedPriority reviewAcceleratedFast trackOct 26, 2001
Chemistry & pharmacology
SMILES
C[C@H](Cn1cnc2c(N)ncnc21)OCP(=O)(O)O.O- Mol. weight
- 305.23 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Availability
- Prescription Only
Oral
No
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL3989702 ↗
- WikipediaTenofovir disoproxil ↗
- NCATSW4HFE001U5 ↗
- ChEMBLCHEMBL483 ↗
- ChEMBLCHEMBL1538 ↗
- ChEMBLCHEMBL1486 ↗
Also known as
- atripla
- atripla
- bis-isopropyloxycarbonylmethyl-9-(2-phosphonomethoxy)propyl-adenine
- bis(isopropyloxymethylcarbonyl) 9-(2-phosphonomethoxypropyl)adenine
- bis-poc-pmpa
- bis(poc)pmpa
- bis(poc)pmpa
- bis(poc)pmpa
- da-2802
- darunavir / cobicistat / emtricitabine / tenofovir alafenamide
- efavirenz / emtricitabine / tenofovir disoproxil fumarate
- efavirenz / emtricitabine / tenofovir disoproxil maleate
- efavirenz / emtricitabine / tenofovir disoproxil, phosphate
- efavirenz / emtricitabine / tenofovir disoproxil succinate
- elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil fumarate
- emtricitabine / rilpivirine hydrochloride /tenofovir disoproxil fumarate
- emtricitabine / tenofovir
- emtricitabine / tenofovir disoproxil fumarate
- emtricitabine / tenofovir disoproxil maleate
- emtricitabine, tenofovir disoproxil phosphate
- emtricitabine / tenofovir disoproxil succinate
- gs-1278
- gs-1278
- gs-4331-05
- gs-4331-05
- gsk548470
- gsk548470
- pmpa
- pmpa
- pmpa prodrug
- pmpa prodrug
- pro 2000
- pro 2000
- pro 2000
- pro 2000/5
- pro 2000/5
- tenefovir
- tenfofovir
- tenfovir
- tenofovir
- tenofovir
- tenofovir
- tenofovir
- tenofovir
- tenofovir
- tenofovir
- tenofovir bis(isopropyloxycarbonyloxymethyl) ester
- tenofovir bis(isopropyloxycarbonyloxymethyl) ester
- tenofovir disoproxil
- tenofovir disoproxil
- tenofovir disoproxil
- tenofovir disoproxil
- tenofovir disoproxil
- tenofovir disoproxil
- tenofovir disoproxil
- tenofovir disoproxil aspartate
- tenofovir disoproxil fumarate
- tenofovir disoproxil fumarate
- tenofovir disoproxil fumarate
- tenofovir disoproxil fumarate
- tenofovir disoproxil fumarate
- tenofovir disoproxil fumarate
- tenofovir disoproxil phosphate
- tenofovir hydrate
- tenofovir hydrate
- tenofovir hydrate
- tenofovir hydrate
- tenofovir hydrate
- tenofovir hydrate
- tfv
- truvada
- truvada
- truvada
- viread
- viread
- viread
- viread
- viread
- viread
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07295873 | Phase 1 | Dec 30, 2025 | GNI Group |
| NCT07054359 | N/A | Nov 30, 2025 | Government of France, Institut National de la Santé Et de la Recherche Médicale, France, University of Geneva |
| NCT07071623 | Phase 3 | Nov 10, 2025 | Merck |
| NCT06908252 | Phase 4 | Sep 17, 2025 | Duke University, National Institute of Allergy and Infectious Diseases (NIAID) |
| NCT07133763 | Phase 1/Phase 2 (Phase 2) | Sep 1, 2025 | Xuzhou Medical University |
| NCT07133776 | Phase 1/Phase 2 (Phase 2) | Sep 1, 2025 | Xuzhou Medical University |
| NCT07095855 | Phase 3 | Aug 31, 2025 | Shanghai Zhimeng Biopharma, Inc. |
| NCT07044297 | Phase 3 | Jul 31, 2025 | Merck |
| NCT06963710 | Phase 2 | Jul 15, 2025 | Aligos Therapeutics |
| NCT07075146 | Phase 3 | May 5, 2025 | Instituto Mexicano del Seguro Social |
| NCT06947356 | N/A | May 3, 2025 | Guangzhou Medical University |
| NCT06780033 | Phase 1 | Mar 17, 2025 | Arnatar Therapeutics, Inc. |
| NCT06816043 | Phase 1 | Feb 21, 2025 | Merck |
| NCT06497465 | Phase 3 | Jan 31, 2025 | Johns Hopkins University, ViiV Healthcare |
| NCT06203132 | Phase 3 | Nov 30, 2024 | Assistance Publique - Hôpitaux de Paris, European and Developing Countries Clinical Trials Partnership (EDCTP), Government of France, Merck |
| NCT06513312 | Phase 2 | Oct 7, 2024 | Gilead Sciences |
| NCT06338826 | Phase 2 | Oct 1, 2024 | Assistance Publique - Hôpitaux de Paris, Government of France |
| NCT06337032 | Phase 4 | Aug 27, 2024 | Gilead Sciences |
| NCT06602622 | Phase 4 | Aug 14, 2024 | Instituto Mexicano del Seguro Social |
| NCT06435026 | Phase 2 | Jun 18, 2024 | National Institute of Allergy and Infectious Diseases (NIAID), University of Colorado, University of North Carolina at Chapel Hill, University of Zimbabwe |
Organizations
Research & Development (526)
Marketing (54)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Amneal Pharmaceuticals | For profit | MKTG | Aug 22, 2018 |
| Apotex | For profit | MKTG | Jul 31, 2018 |
| Apotex | For profit | SYN | Jul 31, 2018 |
| Aurobindo Pharma | For profit | SYN | Jan 26, 2018 |
| Aurobindo Pharma | For profit | MKTG | Oct 18, 2013 |
| Aurobindo Pharma | For profit | NDA2 | Oct 18, 2013 |
| CASI Pharmaceuticals, Inc. | For profit | MKTG | Feb 26, 2018 |
| Celltrion | For profit | MKTG | Nov 16, 2018 |
| Chartwell Pharmaceuticals | For profit | MKTG | Jul 31, 2018 |
| Chartwell Pharmaceuticals | For profit | NDA2 | Nov 16, 2018 |
| Cipla | For profit | SYN | Dec 30, 2013 |
| Cipla | For profit | SYN | Mar 4, 2011 |
| Cipla | For profit | MKTG | Feb 26, 2014 |
| Cipla | For profit | NDA2 | Mar 4, 2011 |
| Desano | For profit | NDA2 | Oct 6, 2020 |
| Emcure | For profit | NDA2 | Jul 12, 2023 |
| Gilead Sciences | For profit | NDA | Oct 26, 2001 |
| Gilead Sciences | For profit | SYN | Aug 2, 2004 |
| Gilead Sciences | For profit | SYN | Jul 12, 2006 |
| Gilead Sciences | For profit | IND | Mar 19, 1997 |
| Hetero Labs Ltd | For profit | MKTG | Jun 30, 2017 |
| Hetero Labs Ltd | For profit | SYN | Mar 14, 2014 |
| Hetero Labs Ltd | For profit | SYN | Oct 31, 2013 |
| Hetero Labs Ltd | For profit | SYN | Dec 22, 2011 |
| Hetero Labs Ltd | For profit | NDA2 | Nov 5, 2009 |
| Laurus Labs Ltd | For profit | MKTG | Feb 1, 2019 |
| Laurus Labs Ltd | For profit | MKTG | Jul 26, 2019 |
| Laurus Labs Ltd | For profit | NDA2 | Feb 1, 2019 |
| Lupin | For profit | NDA2 | Jun 25, 2021 |
| Lupin | For profit | MKTG | Feb 6, 2015 |
| Macleods Pharmaceuticals, Ltd | For profit | MKTG | Nov 8, 2012 |
| Matrix Laboratories Limited | For profit | MKTG | Nov 30, 2007 |
| Matrix Laboratories Limited | For profit | SYN | Mar 30, 2009 |
| Merck | For profit | MKTG | Aug 30, 2018 |
| Merck | For profit | NDA2 | Aug 30, 2018 |
| Micro Labs Ltd India | For profit | MKTG | Dec 18, 2025 |
| Mylan | For profit | SYN | Feb 5, 2018 |
| Mylan | For profit | MKTG | Sep 12, 2014 |
| Mylan | For profit | SYN | Aug 2, 2017 |
| Mylan | For profit | NDA2 | Sep 8, 2011 |
| Neogen | For profit | NDA2 | Nov 8, 2012 |
| Neogen | For profit | MKTG | Jan 26, 2018 |
| PHARMOBEDIENT | For profit | MKTG | Apr 9, 2018 |
| Pharmacare PLC, Palestine | For profit | MKTG | Dec 29, 2016 |
| Qilu Pharmaceutical Co., Ltd. | For profit | SYN | Mar 2, 2018 |
| Qilu Pharmaceutical Co., Ltd. | For profit | MKTG | Mar 2, 2018 |
| Ranbaxy | For profit | MKTG | May 17, 2013 |
| Ranbaxy | For profit | NDA2 | May 17, 2013 |
| Reyoung Pharma Co Ltd | For profit | MKTG | Mar 2, 2023 |
| Reyoung Pharma Co Ltd | For profit | SYN | Mar 2, 2023 |
| Strides Pharma Science | For profit | MKTG | Jul 31, 2013 |
| Strides Pharma Science | For profit | SYN | Dec 7, 2016 |
| Teva | For profit | MKTG | Mar 18, 2015 |
| Zydus Discovery DMCC | For profit | MKTG | Feb 28, 2020 |