Ritonavir
Highest phase reached
Approved
Drug type
Small molecule
First approval year
1996
- First approval year
- 1996
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Ritonavir
- Molecular weight
- 720.96
- Structure (SMILES)
- CC(C)c1nc(CN(C)C(=O)N[C@H](C(=O)N[C@@H](Cc2ccccc2)C[C@H](O)[C@H](Cc2ccccc2)NC(=O)OCc2cncs2)C(C)C)cs1
- norvir
- Norvir
- ritonavir
- Ritonavir
- ritonavir component of kaletra
- Ritonavir component of kaletra
- ritonavir component of paxlovid
- Ritonavir component of paxlovid
- ritonavir component of technivie
- Ritonavir component of technivie
- ritonavir component of viekirax
- Ritonavir component of viekirax
- ritonavir component of xiannuoxin
- Ritonavir component of xiannuoxin
- ritonavir mylan
- Ritonavir mylan
- 100mg ritonavir
- 100mg Ritonavir
- 2 4 7 12 tetraazatridecan 13 oic acid 10 hydroxy 2 methyl 5 1 methylethyl 1 2 1 methylethyl 4 thiazolyl 3 6 dioxo 8 11 bis phenylmethyl 5 thiazolylmethyl ester 5s 5r 8r 10r 11r
- 2,4,7,12-TETRAAZATRIDECAN-13-OIC ACID, 10-HYDROXY-2-METHYL-5-(1-METHYLETHYL)-1-(2-(1-METHYLETHYL)-4-THIAZOLYL)-3,6-DIOXO-8,11-BIS(PHENYLMETHYL)-5-THIAZOLYLMETHYL ESTER (5S-(5R*,8R*,10R*,11R*))-
- 5 thiazolylmethyl αs α 1s 3s 1 hydroxy 3 2s 2 3 2 isopropyl 4 thiazolyl methyl 3 methylureido 3 methylbutyramido 4 phenylbutyl phenethyl carbamate
- 5-Thiazolylmethyl [(αS)-α-[(1S,3S)-1-hydroxy-3-[(2S)-2-[3-[(2-isopropyl-4-thiazolyl)methyl]-3-methylureido]-3-methylbutyramido]-4-phenylbutyl]phenethyl]carbamate
- a 84538
- A-84538
- abbott 84538
- ABBOTT-84538
- abt 538
- ABT-538
- Drug: SCH 900518 Drug: Ritonavir (RTV) Biologic: Peginterferon alfa-2b (PegIntron)
- Drug: SCH 900518 Drug: Ritonavir (RTV) Drug: Ritonavir (RTV) Biologic: Peginterferon alfa-2b (PegIntron)
- empetus
- Empetus
- kaletra component ritonavir
- KALETRA COMPONENT RITONAVIR
- Norvir
- NORVIR tablet 100mg
- nsc 693184
- NSC-693184
- Oral ritonavir
- paxlovid component ritonavir
- PAXLOVID COMPONENT RITONAVIR
And 81 more, listed on the interactive page.
- ATC classification codes
- J05AE03
Sources for recorded values
- CAS registry numbers
- 155213-67-5
- ChEMBL ID
- CHEMBL163
- InChIKey
- NCDNCNXCDXHOMX-XGKFQTDJSA-N
- PubChem compound IDs
- 392622
- RxNorm IDs (RxCUI)
- 85762
- FDA ingredient codes (UNII)
- O3J8G9O825
- Applicant
- ABBVIE
- Approval date
- 15 Sept 2000
- Application number
- NDA021251
- Status
- Authorised
- Status date
- 25 Aug 1996
- Authorisation date
- 25 Aug 1996
- Approved indications
- Ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV-1-infected patients (adults and children of two years of age and older).
- Product number
- EMEA/H/C/000127
- Authorisation holder
- AbbVie Deutschland GmbH & Co. KG
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 1
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- HIV Infections
European medicines record
- Patents
- 0
- Designations
- 3
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- Yes
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- ritonavir
- Type
- Synthetic organic
- Drug name stem
- -vir
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Oral
- Action
- Agonist
- Action type
- Agonist
- Target
- TAS2R14
- Gene symbol
- TAS2R14
- Protein identifier
- Q9NYV8
- Action
- Agonist
- Action type
- Agonist
- Target
- TAS2R8
- Gene symbol
- TAS2R8
- Protein identifier
- Q9NYW2
- Action
- Agonist
- Action type
- Agonist
- Target
- TAS2R1
- Gene symbol
- TAS2R1
- Protein identifier
- Q9NYW7
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- CYP3A4
- Gene symbol
- CYP3A4
- Protein identifier
- P08684
- Median affinity
- 7
- Affinity units
- pKi
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- CYP3A5
- Gene symbol
- CYP3A5
- Protein identifier
- P20815
- Median affinity
- 6.92
- Affinity units
- pKi
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- UDP glucuronosyltransferase family 1 member A1
- Gene symbol
- UGT1A1
- Protein identifier
- P22309
- Median affinity
- 5.77
- Affinity units
- pIC50
- Mechanism
- Cytochrome P450 3A inhibitor
- Action type
- Inhibitor
- Target
- Cytochrome P450 3A
- Protein identifier
- P08684
- Mechanism
- Cytochrome P450 3A inhibitor
- Action type
- Inhibitor
- Target
- Cytochrome P450 3A
- Protein identifier
- P20815
- Mechanism
- Cytochrome P450 3A inhibitor
- Action type
- Inhibitor
- Target
- Cytochrome P450 3A
- Protein identifier
- P24462
- Mechanism
- Cytochrome P450 3A inhibitor
- Action type
- Inhibitor
- Target
- Cytochrome P450 3A
- Protein identifier
- Q9HB55
- Mechanism
- Human immunodeficiency virus type 1 protease inhibitor
- Action type
- Inhibitor
- Target
- Human immunodeficiency virus type 1 protease
- Protein identifier
- Q72874
- Mechanism
- Cytochrome P450 3A inhibitor
- Action type
- Inhibitor
- Target
- Cytochrome P450 3A
- Mechanism
- Human immunodeficiency virus type 1 protease inhibitor
- Action type
- Inhibitor
- Target
- Human immunodeficiency virus type 1 protease
- Action type
- Inhibitor
- Gene symbol
- CYP3A5
- Protein identifier
- P20815
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- Inhibitor
- Gene symbol
- UGT1A1
- Protein identifier
- P22309
- Organism
- Homo sapiens
- Target development level
- Biological evidence
- Action type
- Inhibitor
- Gene symbol
- pol
- Protein identifier
- Q72874
- Organism
- Human immunodeficiency virus 1
- Condition
- HIV Infections
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000180
- Subject identifier
- D015658
- Condition
- Glioblastoma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000519
- Subject identifier
- D005909
- Condition
- Hypertension
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000537
- Subject identifier
- D006973
- Condition
- Infections
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000544
- Subject identifier
- D007239
- Condition
- Sarcoma, Kaposi
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000558
- Subject identifier
- D012514
- Condition
- Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Prostatic Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000673
- Subject identifier
- D011471
- Condition
- Sarcoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000691
- Subject identifier
- D012509
- Condition
- Severe Acute Respiratory Syndrome
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000694
- Subject identifier
- D045169
- Condition
- Virus Diseases
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000763
- Subject identifier
- D014777
- Condition
- HIV Infections
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000764
- Subject identifier
- D015658
- Condition
- Acquired Immunodeficiency Syndrome
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000765
- Subject identifier
- D000163
- Condition
- Malaria
- Highest recorded phase
- 1
- Condition identifier
- EFO:0001068
- Subject identifier
- D008288
- Condition
- Hypertension, Pulmonary
- Highest recorded phase
- 1
- Condition identifier
- EFO:0001361
- Subject identifier
- D006976
- Condition
- Liver Diseases
- Highest recorded phase
- 1
- Condition identifier
- EFO:0001421
- Subject identifier
- D008107
- Condition
- Insulin Resistance
- Highest recorded phase
- 1
- Condition identifier
- EFO:0002614
- Subject identifier
- D007333
- Condition
- Pregnancy
- Highest recorded phase
- 2
- Condition identifier
- EFO:0002950
- Subject identifier
- D011247
- Condition
- Hepatitis C
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003047
- Subject identifier
- D006526
- Condition
- Kidney Diseases
- Highest recorded phase
- 1
- Condition identifier
- EFO:0003086
- Subject identifier
- D007674
- Condition
- Pneumonia
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003106
- Subject identifier
- D011014
- Condition
- Anus Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- EFO:0003835
- Subject identifier
- D001005
- Condition
- Hepatitis B, Chronic
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004197
- Subject identifier
- D019694
- Condition
- Hepatitis C, Chronic
- Highest recorded phase
- 4
- Condition identifier
- EFO:0004220
- Subject identifier
- D019698
- Condition
- Erectile Dysfunction
- Highest recorded phase
- 1
- Condition identifier
- EFO:0004234
- Subject identifier
- D007172
- Condition
- Coronavirus Infections
- Highest recorded phase
- 3
- Condition identifier
- EFO:0007224
- Subject identifier
- D018352
And 13 more, listed on the interactive page.
- Condition identifier
- EFO_0000180
- Condition identifier
- EFO_0000180
- Highest recorded phase
- 4
- Condition identifier
- EFO_0000544
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000558
- Condition identifier
- EFO_0000694
- Condition identifier
- EFO_0000763
- Condition identifier
- EFO_0000764
- Condition identifier
- EFO_0000765
- Highest recorded phase
- 3
- Condition identifier
- EFO_0001361
- Highest recorded phase
- 1
- Condition identifier
- EFO_0001421
- Highest recorded phase
- 1
- Condition identifier
- EFO_0002950
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003047
- Condition identifier
- EFO_0003086
- Highest recorded phase
- 1
- Condition identifier
- EFO_0003835
- Highest recorded phase
- 1
- Condition identifier
- EFO_0004220
- Condition identifier
- EFO_0004234
- Highest recorded phase
- 1
- Condition identifier
- EFO_0007224
- Highest recorded phase
- 3
- Condition identifier
- EFO_0007304
- Highest recorded phase
- 3
- Condition identifier
- EFO_0008496
- Highest recorded phase
- 2
- Condition identifier
- EFO_0009708
- Highest recorded phase
- 1
- Condition identifier
- HP_0001394
- Highest recorded phase
- 3
- Condition identifier
- HP_0001395
- Highest recorded phase
- 2
- Condition identifier
- HP_0002094
- Highest recorded phase
- 2
- Condition identifier
- HP_0002783
- Highest recorded phase
- 2
- Condition identifier
- HP_0012378
- Highest recorded phase
- 2
And 49 more, listed on the interactive page.
Warnings
- Warning
- Black Box Warning
Open Targets warnings
- Warning
- Black Box Warning
- Country
- United States
- Event
- abortion induced
- Reports
- 267
- Reporting signal score
- 472.119
- Event
- abortion spontaneous
- Reports
- 690
- Reporting signal score
- 997.175
- Event
- blood bilirubin increased
- Reports
- 322
- Reporting signal score
- 358.823
- Event
- cushing's syndrome
- Reports
- 264
- Reporting signal score
- 685.503
- Event
- drug interaction
- Reports
- 1,293
- Reporting signal score
- 1,051.19
- Event
- drug resistance
- Reports
- 397
- Reporting signal score
- 556.68
- Event
- foetal death
- Reports
- 121
- Reporting signal score
- 248.605
- Event
- hyperbilirubinaemia
- Reports
- 414
- Reporting signal score
- 920.436
- Event
- hypertriglyceridaemia
- Reports
- 183
- Reporting signal score
- 335.846
- Event
- immune reconstitution inflammatory syndrome
- Reports
- 233
- Reporting signal score
- 496.3
- Event
- immune reconstitution syndrome
- Reports
- 145
- Reporting signal score
- 456.071
- Event
- injection site pain
- Reports
- 1
- Reporting signal score
- 254.887
- Event
- jaundice
- Reports
- 355
- Reporting signal score
- 404.95
- Event
- lipodystrophy acquired
- Reports
- 375
- Reporting signal score
- 1,335.99
- Event
- live birth
- Reports
- 205
- Reporting signal score
- 460.767
- Event
- low birth weight baby
- Reports
- 179
- Reporting signal score
- 296.18
- Event
- mitochondrial toxicity
- Reports
- 147
- Reporting signal score
- 541.033
- Event
- premature baby
- Reports
- 629
- Reporting signal score
- 1,017.51
- Event
- premature delivery
- Reports
- 300
- Reporting signal score
- 462.29
- Event
- progressive external ophthalmoplegia
- Reports
- 75
- Reporting signal score
- 338.688
- Event
- renal colic
- Reports
- 113
- Reporting signal score
- 289.389
- Event
- renal tubular disorder
- Reports
- 128
- Reporting signal score
- 263.858
- Event
- stillbirth
- Reports
- 237
- Reporting signal score
- 589.952
- Event
- viral load increased
- Reports
- 126
- Reporting signal score
- 288.627
- Event
- viral mutation identified
- Reports
- 143
- Reporting signal score
- 293.204
And 1 more, listed on the interactive page.
- NCT00000822
- NCT00000891
- NCT00000902
- NCT00000906
- NCT00000913
- NCT00000918
- NCT00000924
- NCT00000940
- NCT00000941
- NCT00000952
- NCT00001083
- NCT00001087
- NCT00001091
- NCT00001108
- NCT00001133
- NCT00001688
- NCT00001766
- NCT00002178
- NCT00002239
- NCT00002241
- NCT00002361
- NCT00002374
- NCT00002378
- NCT00002440
- NCT00002447
And 372 more, listed on the interactive page.
- Dose
- 600 mg
- Route
- Oral
- How often
- Twice daily
Conditions of use
- With meals
- Hydrogen bond acceptors
- 9
- Hydrogen bond donors
- 4
- Polar surface area
- 145.78
- Calculated partition coefficient (ALogP)
- 5.91
- Calculated partition coefficient (XLogP)
- 6
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Rule-of-five violations
- 2
- Rotatable bonds
- 17
- Heavy atoms
- 50
- Molecular formula
- C37H48N6O5S2
- Monoisotopic mass
- 720.31276100
- Natural product
- Yes
- 0074-2340
- 0074-3008
- 0074-3399
- 0074-3956
- 0074-4014
- 31722-556
- 31722-597
- 31722-603
- 33342-163
- 33342-164
- 42385-933
- 42385-934
- 60687-420
- 65162-061
- 65862-687
- 69097-655
- 63629-5702
- 68071-3898
- 71335-2610
- Recorded assays
- 4,217
- Active assays
- 402
- Confirmatory
- Other
- Screening
- Summary
- HIV Protease Inhibitors
- Cytochrome P-450 CYP3A Inhibitors
These details could not be displayed.
Related records
Trials (797)
- "OK 2004 Study" (Only Kaletra 2004 Study): Study to Evaluate Suspending Nucleosides From Triple-Drug Therapy in HIV Subjects
- "The Once A Day Protease Inhibitor Regimens"
- 48-Week Study Of GW433908 And Ritonavir Or GW433908 Alone, Twice Daily In Pediatric Patients With HIV Infection
- A Bioavailability Study of Rifabutin and Lopinavir/Ritonavir in Healthy Adult Subjects
- A Clinical Study Of An Investigational Regimen Including Marketed HIV Drugs In HIV-1 Pediatric Subjects Ages 2-18 Years
- A Clinical Trial Comparing the Efficacy of Darunavir/Ritonavir Monotherapy Versus a Triple Combination Therapy Containing Darunavir/Ritonavir and 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Patients With Undetectable Plasma HIV-1 RNA on Current Treatment
- A Comparison of Three Anti-HIV Drug Combinations Containing Saquinavir Soft Gelatin Capsules Used in HIV-1 Infected Patients
- A Comparison of Three Drug Combinations Containing Clarithromycin in the Treatment of Mycobacterium Avium Complex (MAC) Disease in Patients With AIDS
- A Comparison of Two Anti-HIV Drug Regimens for Youth Who Have Failed Prior Therapy
- A Decentralized, Randomized Phase 2 Efficacy and Safety Study of Nirmatrelvir/Ritonavir in Adults with Long COVID.
- A Dose Ranging Study Of GW640385 Boosted With Ritonavir (Rtv) In Comparison To A RTV-Boosted Protease Inhibitor (PI) In HIV-1 Infected PI-Experienced Adults
- A Drug Interaction Study to Assess the Pharmacokinetics of Narlaprevir and Antiretroviral Drugs
- A Drug-drug Interaction (DDI) Study of Morphothiadine Mesilate/Ritonavir in Healthy Subjects
- A Drug-drug Interaction Study Between Daclatasvir and Atazanavir/Ritonavir or Atazanavir/Cobicistat
- A Drug-Drug Interaction Study Between Danoprevir/Low-Dose Ritonavir and Cyclosporine in Healthy Volunteers
- A Drug-Drug Interaction Study of Ketoconazole, Rifampicin and Ritonavir-Boosted Atazanavir With Single-Dose RO5093151 in Healthy Volunteers
- A First Time in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Single and Repeat Doses of GSK2485852 in Chronically Infected Hepatitis C Subjects
- A Follow up Study Designed to Obtain Long Term Data on Participants Who Either Achieved a Sustained Virologic Response or Did Not Achieve a Sustained Virologic Response in an AbbVie Sponsored Hepatitis C Study
- A Multi-centre, Double-blinded, Randomized, Placebo-controlled Trial on the Efficacy and Safety of Lopinavir / Ritonavir Plus Ribavirin in the Treatment of Severe Acute Respiratory Syndrome
- A Multicenter Study to Assess the Tolerability of Once Daily Lopinavir/Ritonavir (LPV/r) Liquid Versus Capsules
Approved for (4)
- Chronic hepatitis C virus infection
- Hepatitis C virus infection
- HIV infectious disease
- Viral infectious disease
In development for (28)
- Acute respiratory distress syndrome Phase 1
- AIDS Phase 3
- Amyotrophic lateral sclerosis Phase 1
- Anus neoplasm Phase 1
- Cancer Phase 2
- COVID-19 Phase 3
- Erectile dysfunction Phase 1
- Glioblastoma Phase 1
- Hepatitis B virus infection Phase 2
- Hepatitis D virus infection Phase 3
- Hypertensive disorder Phase 1
- Influenza Phase 3
- Kaposi's sarcoma Phase 2
- Kidney disorder Phase 1
- Liver disorder Phase 1
- Long COVID-19 Phase 2
- Malaria Phase 1
- Malignant glioma Phase 1
- Middle East respiratory syndrome Phase 3
- Mycobacterium avium complex disease Phase 2