Tenofovir disoproxil
Highest phase reached
Approved
Drug type
Small molecule
First approval year
2001
- First approval year
- 2001
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Tenofovir disoproxil
- Molecular weight
- 519.45
- Structure (SMILES)
- CC(C)OC(=O)OCOP(=O)(CO[C@H](C)Cn1cnc2c(N)ncnc21)OCOC(=O)OC(C)C
- tenofovir disoproxil component of stribild
- Tenofovir disoproxil component of stribild
- viread
- Viread
- (r)-bis(poc)pmpa
- bis poc pmpa
- Bis-poc-pmpa
- gs 4331
- GS-4331
- r bis poc pmpa
- stribild component tenofovir disoproxil
- STRIBILD COMPONENT TENOFOVIR DISOPROXIL
- tenofovir bis isopropyloxycarbonyloxymethyl ester
- tenofovir bis isopropyloxycarbonyloxymethyl ester mi
- Tenofovir bis(isopropyloxycarbonyloxymethyl) ester
- TENOFOVIR BIS(ISOPROPYLOXYCARBONYLOXYMETHYL) ESTER [MI]
- tenofovir disoproxil
- Tenofovir disoproxil
- Tenofovir Disoproxil
- TENOFOVIR DISOPROXIL [EMA EPAR]
- Tenofovir disoproxil [WHO-DD]
- tenofovir disoproxil ema epar
- tenofovir disoproxil who dd
- ATC classification codes
- J05AF07
Sources for recorded values
- CAS registry numbers
- 201341-05-1
- ChEMBL ID
- CHEMBL1538
- InChIKey
- JFVZFKDSXNQEJW-CQSZACIVSA-N
- PubChem compound IDs
- 5481350
- FDA ingredient codes (UNII)
- F4YU4LON7I
- 300195
- 1928942
- Applicant
- GILEAD SCIENCES INC
- Approval date
- 26 Oct 2001
- Application number
- NDA021356
- Status
- Authorised
- Status date
- 4 Feb 2002
- Authorisation date
- 4 Feb 2002
- Approved indications
- HIV 1 infection Viread 123 mg film coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, aged 6 to < 12 years who weigh from 17 kg to less than 22 kg. The choice of Viread to treat antiretroviral experienced patients with HIV 1 infection should be based on individual viral resistance testing and/or treatment history of patients. Hepatitis B infection Viread 123 mg film coated tablets are indicated for the treatment of chronic hepatitis B in paediatric patients aged 6 to < 12 years who weigh from 17 kg to less than 22 kg, with compensated liver disease and evidence of immune active disease, i.e. active viral replication and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis. With respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, 4.8 and 5.1. HIV 1 infection Viread 163 mg film coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, aged 6 to < 12 years who weigh from 22 kg to less than 28 kg. The choice of Viread to treat antiretroviral experienced patients with HIV 1 infection should be based on individual viral resistance testing and/or treatment history of patients. Hepatitis B infection Viread 163 mg film coated tablets are indicated for the treatment of chronic hepatitis B in paediatric patients aged 6 to < 12 years who weigh from 22 kg to less than 28 kg, with: compensated liver disease and evidence of immune active disease, i.e. active viral replication and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis. With respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, 4.8 and 5.1. HIV 1 infection Viread 204 mg film coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, aged 6 to < 12 years who weigh from 28 kg to less than 35 kg. The choice of Viread to treat antiretroviral experienced patients with HIV 1 infection should be based on individual viral resistance testing and/or treatment history of patients. Hepatitis B infection Viread 204 mg film coated tablets are indicated for the treatment of chronic hepatitis B in paediatric patients aged 6 to < 12 years who weigh from 28 kg to less than 35 kg, with: compensated liver disease and evidence of immune active disease, i.e. active viral replication and persistently elevated serum ALT levels or histological evidence of moderate to severe inflammation and/or fibrosis. With respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, 4.8 and 5.1. HIV 1 infection Viread 245 mg film coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected adults. In adults, the demonstration of the benefit of Viread in HIV 1 infection is based on results of one study in treatment naïve patients, including patients with a high viral load (> 100,000 copies/ml) and studies in which Viread was added to stable background therapy (mainly tritherapy) in antiretroviral pre-treated patients experiencing early virological failure (< 10,000 copies/ml, with the majority of patients having < 5,000 copies/ml). Viread 245 mg film coated tablets are also indicated for the treatment of HIV 1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years. The choice of Viread to treat antiretroviral experienced patients with HIV 1 infection should be based on individual viral resistance testing and/or treatment history of patients. Hepatitis B infection Viread 245 mg film coated tablets are indicated for the treatment of chronic hepatitis B in adults with: compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis (see section 5.1). evidence of lamivudine resistant hepatitis B virus (see sections 4.8 and 5.1). decompensated liver disease (see sections 4.4, 4.8 and 5.1). Viread 245 mg film coated tablets are indicated for the treatment of chronic hepatitis B in adolescents 12 to < 18 years of age with: compensated liver disease and evidence of immune active disease, i.e. active viral replication and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis. With respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, 4.8 and 5.1. HIV 1 infection Viread 33 mg/g granules are indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, from 2 to < 6 years of age, and above 6 years of age for whom a solid dosage form is not appropriate. Viread 33 mg/g granules are also indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected adults for whom a solid dosage form is not appropriate. In adults, the demonstration of the benefit of Viread in HIV 1 infection is based on results of one study in treatment naïve patients, including patients with a high viral load (> 100,000 copies/ml) and studies in which Viread was added to stable background therapy (mainly tritherapy) in antiretroviral pre-treated patients experiencing early virological failure (< 10,000 copies/ml, with the majority of patients having < 5,000 copies/ml). The choice of Viread to treat antiretroviral experienced patients with HIV 1 infection should be based on individual viral resistance testing and/or treatment history of patients. Hepatitis B infection Viread 33 mg/g granules are indicated for the treatment of chronic hepatitis B in adults for whom a solid dosage form is not appropriate with: compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis (see section 5.1). evidence of lamivudine resistant hepatitis B virus (see sections 4.8 and 5.1). decompensated liver disease (see sections 4.4, 4.8 and 5.1). Viread 33 mg/g granules are also indicated for the treatment of chronic hepatitis B in paediatric patients2 to < 18 years of age for whom a solid dosage form is not appropriate with: compensated liver disease and evidence of immune active disease, i.e. active viral replication, and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis. With respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, 4.8 and 5.1.
- Product number
- EMEA/H/C/000419
- Authorisation holder
- Gilead Sciences Ireland UC
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 2
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Hepatitis B, Chronic
- HIV Infections
European medicines record
- First in class
- No
- Orphan designation
- No
- Availability
- Prescription only
- Boxed warning
- Yes
- United States (FDA)
- Approved
- European Union (EMA)
- Authorised
- Drug name stem
- -vir
Administration routes
- Oral
- Mechanism
- DNA polymerase/reverse transcriptase inhibitor
- Action type
- Inhibitor
- Target
- DNA polymerase/reverse transcriptase
- Mechanism
- Human immunodeficiency virus type 1 reverse transcriptase inhibitor
- Action type
- Inhibitor
- Target
- Human immunodeficiency virus type 1 reverse transcriptase
DrugCentral mechanisms
- Action type
- Inhibitor
- Gene symbol
- pol
- Protein identifier
- Q72547
- Organism
- Human immunodeficiency virus 1
- Condition
- Virus Diseases
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000763
- Subject identifier
- D014777
- Condition
- HIV Infections
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000764
- Subject identifier
- D015658
- Condition
- Hepatitis B, Chronic
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004197
- Subject identifier
- D019694
- Condition
- Hepatitis C, Chronic
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004220
- Subject identifier
- D019698
- Condition
- Hepatitis B, Chronic
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004239
- Subject identifier
- D019694
- Condition
- Hepatitis D
- Highest recorded phase
- 2
- Condition identifier
- EFO:0007304
- Subject identifier
- D003699
- Condition
- Liver Cirrhosis, Biliary
- Highest recorded phase
- 2
- Condition identifier
- EFO:1001486
- Subject identifier
- D008105
- Condition
- Hepatitis
- Highest recorded phase
- 1
- Condition identifier
- HP:0012115
- Subject identifier
- D006505
- Condition
- Severe Acute Respiratory Syndrome
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0100096
- Subject identifier
- D045169
- Condition identifier
- EFO_0000763
- Condition identifier
- EFO_0000764
- Condition identifier
- EFO_0004197
- Condition identifier
- EFO_0004239
- Condition identifier
- EFO_1001486
- Highest recorded phase
- 2
- Condition identifier
- HP_0012115
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005108
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005109
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005344
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005344
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005354
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005366
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005366
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005388
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005789
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0007256
- Condition identifier
- MONDO_0100096
- Highest recorded phase
- 3
- Warning
- Black Box Warning
- Effect
- hepatotoxicity
- Country
- United States
- Warning
- Black Box Warning
- Effect
- immune system toxicity
- Country
- United States
- Event
- abortion spontaneous
- Reports
- 305
- Reporting signal score
- 396.782
- Event
- birth mark
- Reports
- 44
- Reporting signal score
- 182.484
- Event
- blood creatinine increased
- Reports
- 318
- Reporting signal score
- 326.874
- Event
- blood hiv rna increased
- Reports
- 123
- Reporting signal score
- 442.529
- Event
- blood phosphorus decreased
- Reports
- 93
- Reporting signal score
- 232.831
- Event
- chronic hepatitis b
- Reports
- 49
- Reporting signal score
- 205.882
- Event
- chronic kidney disease
- Reports
- 155
- Reporting signal score
- 217.903
- Event
- congenital umbilical hernia
- Reports
- 60
- Reporting signal score
- 237.018
- Event
- csf hiv escape syndrome
- Reports
- 76
- Reporting signal score
- 381.695
- Event
- csf virus identified
- Reports
- 36
- Reporting signal score
- 175.797
- Event
- diplopia
- Reports
- 126
- Reporting signal score
- 149.833
- Event
- drug resistance
- Reports
- 739
- Reporting signal score
- 1,944.63
- Event
- eyelid ptosis
- Reports
- 128
- Reporting signal score
- 241.291
- Event
- fanconi syndrome
- Reports
- 159
- Reporting signal score
- 589.165
- Event
- fanconi syndrome acquired
- Reports
- 255
- Reporting signal score
- 1,034.5
- Event
- genotype drug resistance test positive
- Reports
- 95
- Reporting signal score
- 298.485
- Event
- glycosuria
- Reports
- 92
- Reporting signal score
- 310.307
- Event
- hepatitis b
- Reports
- 149
- Reporting signal score
- 363.884
- Event
- hepatitis b dna increased
- Reports
- 68
- Reporting signal score
- 241.522
- Event
- hepatitis b reactivation
- Reports
- 91
- Reporting signal score
- 230.685
- Event
- hiv infection
- Reports
- 52
- Reporting signal score
- 145.616
- Event
- hypophosphataemia
- Reports
- 210
- Reporting signal score
- 535.688
- Event
- immune reconstitution inflammatory syndrome
- Reports
- 328
- Reporting signal score
- 1,021.45
- Event
- immune reconstitution syndrome
- Reports
- 63
- Reporting signal score
- 186.237
- Event
- lipodystrophy acquired
- Reports
- 213
- Reporting signal score
- 778.532
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- Dose
- 300 mg
- Route
- Oral
- How often
- Once daily
- Hydrogen bond acceptors
- 15
- Hydrogen bond donors
- 1
- Polar surface area
- 185.44
- Calculated partition coefficient (ALogP)
- 3.04
- Calculated partition coefficient (XLogP)
- 1.6
- Prodrug
- Yes
- Chirality
- Single enantiomer
- Inorganic
- No
- Rule-of-five violations
- 2
- Rotatable bonds
- 13
- Heavy atoms
- 35
- Molecular formula
- C19H30N5O10P
- Monoisotopic mass
- 519.17302917
- Natural product
- Yes
- Recorded assays
- 235
- Active assays
- 13
- Confirmatory
- Screening
- Anti-HIV Agents
Agents used to treat AIDS and/or stop the spread of the HIV infection. These do not include drugs used to treat symptoms or opportunistic infections associated with AIDS.
- Antiviral Agents
Agents used in the prophylaxis or therapy of VIRUS DISEASES. Some of the ways they may act include preventing viral replication by inhibiting viral DNA polymerase; binding to specific cell-surface receptors and inhibiting viral penetration or uncoating; inhibiting viral protein synthesis; or blocking late stages of virus assembly.
- Reverse Transcriptase Inhibitors
Inhibitors of reverse transcriptase (RNA-DIRECTED DNA POLYMERASE), an enzyme that synthesizes DNA on an RNA template.
Distribution coefficient (LogD)
- Median
- 1.26
- Mean
- 1.26
- Minimum
- 1.26
- Maximum
- 1.26
- Unit
- unitless
- Assays
- 1
- Standard deviation
- 0
- Summary method
- median
- Censored results excluded
- 0
- Other units excluded
- 0
- Unknown units excluded
- 0
Measurement types
- LogD
Related records
Trials (168)
- A Demonstration Project to Add Pre- or Post-exposure Prophylaxis to Combination HIV Prevention Services
- A Dose-Ranging Study to Compare Doravirine (MK-1439) Plus TRUVADA® Versus Efavirenz Plus TRUVADA® in Human Immunodeficiency Virus (HIV)-1 Infected Participants (MK-1439-007)
- A phase4 Clinical Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Disoproxil From Tenofovir Disoproxil Fumarate in Patients With Chronic Hepatitis B
- A Pilot Study on Raltegravir, Tenofovir and Emtricitabine for Peri-exposure Prophylaxis for HIV Infection
- A Pilot Study to Determine if Raltegravir Eradicates HIV From Peripheral Blood Mononuclear Cells
- A Randomized, Open-label, Single-dosing, 2X2 Crossover Study to Compare the Safety and Pharmacokinetics of BR-TND Tablet(Tenofovir Disoproxil) With Viread Tablet(Tenofovir Disoproxil Fumarate) in Healthy Male Volunteers
- A Simplification Study of Unboosted Reyataz With Epzicom (ASSURE)
- A Study Exploring an Induction-Maintenance Kaletra-Based Therapy Versus a Sustiva-Based Regimen in Previously Non-Treated, HIV-1/HCV Co-Infected Subjects
- A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus
- A Study of JNJ-73763989, JNJ-56136379, Nucleos(t)Ide Analogs, and Pegylated Interferon Alpha-2a in Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection
- A Study of JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, Hepatitis B e Antigen (HBeAg)- Negative Participants With Chronic Hepatitis B Virus Infection
- A Study of JNJ-73763989, Pegylated Interferon Alpha-2a and Nucleos(t)Ide Analogs in Participants With Chronic Hepatitis B Virus Infection
- A Study of JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog (NA) With or Without JNJ-56136379 in Treatment-naive Participants With Hepatitis B e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (HBV) Infection
- A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)
- A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection
- A Study to Determine the Safety and Efficacy of Once Daily Raltegravir Compared to Twice Daily Raltegravir (MK-0518-071)
- Accelerated PrEP Access for Black MSM and TW
- Acceptability, Safety, and Use of Daily Truvada Pre-Exposure Prophylaxis in Adolescents
- ADVANCE Study of DTG + TAF + FTC vs DTG + TDF + FTC and EFV + TDF+FTC in First-line Antiretroviral Therapy
- Advanced Neuroimaging Evaluation of the Central Nervous System Biological Changes Associated With Efavirenz Therapy and Switch to an Elvitegravir-based Regimen
Approved for (1)
In development for (8)
- Chronic hepatitis B virus infection Phase 2
- Chronic hepatitis C virus infection Phase 2
- COVID-19 Phase 3
- Hepatitis Phase 1
- Hepatitis B virus infection Phase 2
- Hepatitis D virus infection Phase 2
- HIV infectious disease Phase 3
- Primary biliary cholangitis Phase 2