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Agenerase (AMPRENAVIR)
Agenerase (amprenavir) is a protease inhibitor, a type of antiretroviral medication, originally developed by GlaxoSmithKline and currently owned by the same company. It targets the cytochrome P450 3A4 enzyme and is used to treat human immunodeficiency virus (HIV) infection. Agenerase was FDA-approved in 1999 and is now off-patent, meaning it is no longer protected by active patents. As a result, there are currently no generic manufacturers of the drug. Despite its off-patent status, Agenerase remains a commercial product.
At a glance
| Generic name | AMPRENAVIR |
|---|---|
| Sponsor | GSK |
| Drug class | Protease Inhibitor |
| Target | Cytochrome P450 3A4 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 1999 |
Approved indications
- Human immunodeficiency virus infection
Common side effects
Drug interactions
- atorvastatin
- bepridil
- bosentan
- cerivastatin
- cisapride
- clomipramine
- clozapine
- desogestrel
- doxepin
- ergotamine
- erythromycin
- estradiol
Key clinical trials
- Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy
- Dual Boosted - Protease Inhibitor (PI) Pharmacokinetics (PK) Trial (Tipranavir / Ritonavir) in Highly Treatment-experienced HIV-1 Infected Patients (PHASE2)
- Study Of An Investigational Regimen Including FDA Approved HIV Drugs In HIV-Infected Pediatric Subjects (PHASE2)
- Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children (PHASE2,PHASE3)
- A Study of 141W94 Used Alone or in Combination With Zidovudine Plus 3TC in HIV-Infected Patients (PHASE2)
- A Study of Three Anti-HIV Drug Combinations in Patients Who Have Taken Amprenavir (PHASE2)
- A Study to See If Taking One or Two Extra Drugs Can Lower HIV Levels in Patients Who Have Failed Their Anti-HIV Drug Treatment (PHASE2)
- Drug Interactions of Amprenavir and Efavirenz, in Combination With a Second Protease Inhibitor, in HIV-Negative Volunteers (NA)
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:
- Agenerase CI brief — competitive landscape report
- Agenerase updates RSS · CI watch RSS
- GSK portfolio CI