Last reviewed · How we verify
TIPRANAVIR
At a glance
| Generic name | TIPRANAVIR |
|---|---|
| Drug class | Protease Inhibitor [EPC] |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2005 |
Approved indications
Boxed warnings
- WARNING: HEPATOTOXICITY and INTRACRANIAL HEMORRHAGE WARNING: HEPATOTOXICITY and INTRACRANIAL HEMORRHAGE See full prescribing information for complete boxed warning. Clinical hepatitis and hepatic decompensation including some fatalities. Extra vigilance is warranted in patients with chronic hepatitis B or hepatitis C co-infection. ( 5.2 ) Fatal and non-fatal intracranial hemorrhage ( 5.3 ) Hepatotoxicity: Clinical hepatitis and hepatic decompensation, including some fatalities, have been reported. Extra vigilance is warranted in patients with chronic hepatitis B or hepatitis C co-infection, as these patients have an increased risk of hepatotoxicity [ see Warnings and Precautions (5.2) ] . Intracranial Hemorrhage: Both fatal and non-fatal intracranial hemorrhage have been reported [ see Warnings and Precautions (5.3) ] .
Common side effects
- anemia
- neutropenia
- diarrhea
- nausea
- vomiting
- abdominal pain
- abdominal pain upper
- pyrexia
- fatigue
- weight decreased
- ALT increased
- GGT increased
Drug interactions
- drugs highly dependent on CYP3A for clearance
- other CYP3A substrates
- drugs that induce CYP3A and/or P-gp
Key clinical trials
- Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy (PHASE3)
- Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy
- Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (PHASE2, PHASE3)
- Study to Determine the Pharmacokinetics on TPV/r in Subjects With Mild and Moderate Hepatic Insufficiency (PHASE1)
- Pharmacokinetics (PK) of Tipranavir/Ritonavir, Ribavirin, Pegylated Interferon (Peg INF) in Hepatitis C (HCV) Subjects With Mild Hepatic Impairment and in HCV, Hepatitis B (HBV), Hepatitis D Infected Subjects or Alcoholic Cirrhosis With Moderate Hepatic Impairment (PHASE1)
- Dual Boosted - Protease Inhibitor (PI) Pharmacokinetics (PK) Trial (Tipranavir / Ritonavir) in Highly Treatment-experienced HIV-1 Infected Patients (PHASE2)
- 3 TPV/RTV Doses in Multiple ARV Experienced Patients - Tipranavir Dose Defining Study (PHASE2)
- Optimizing Treatment for Treatment-Experienced, HIV-Infected People (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- TIPRANAVIR CI brief — competitive landscape report
- TIPRANAVIR updates RSS · CI watch RSS