Amprenavir
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Agenerase | — | 2010-04-29 | europa.eu ↗ |
| Label expansions (2) | US (FDA) | AGENERASE | — | 2001-05-11 – 2002-02-05 | fda.gov ↗ |
| Approved | EU (EMA) | Agenerase | — | 2000-10-20 | europa.eu ↗ |
| Approved | US (FDA) | AGENERASE | — | 1999-04-15 | fda.gov ↗ |
Trials 39
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 46 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Amprenavir | “Generic names: Efavirenz/Emtricitabine/Tenofovir, Lamivudine/Zidovudine, Emtricitabine, Lamivudine, Abacavir/Lamivudine, Zidovudine, Abacavir/Lamivudine/Zidovudine,...” NCT00624195 ↗43“It may include one or two nucleoside reverse transcriptase inhibitors, such as zidovudine, didanosine, lamuvidine, zalcitabine, stavudine), a non- nucleoside reverse...” NCT00032669 ↗ “Protease inhibitors (PIs) included amprenavir, atazanavir, darunavir, fosamprenavir, Kaletra (lopinavir/ritonavir, coformulated), ritonavir, and saquinavir.” NCT01252940 ↗ “Accepted PIs: amprenavir (APV).” NCT00039741 ↗ |
| Known as | 141W94 | “A Phase II Study of 1) Amprenavir (141W94/VX478) Plus 3TC Plus ZDV (or d4T) or 2) IDV Plus NVP Plus 3TC Plus d4T in Subjects Previously Treated With Amprenavir and 3) Other...” NCT00001095 ↗5“Amprenavir (141W94) Open Label Protocol for Subjects With HIV-1 Infection Who Have Experienced Treatment Failure or Are Intolerant to Previous Protease Inhibitor Therapy” NCT00002405 ↗ “A Study of 141W94 in Combination With Other Anti-HIV Drugs” NCT00002372 ↗ “141W94 (amprenavir [APV])” NCT00006617 ↗ “Amprenavir (141W94)” NCT00002419 ↗ “141W94 (amprenavir)” NCT00002216 ↗ |
| Known as | Agenerase | ChEMBL registry synonym — accepted as the source's own label CHEMBL116 ↗ |
| Known as | APV | “Adult AIDS Clinical Trials Group 5043 examined pharmacokinetic (PK) interactions between amprenavir (APV) and efavirenz (EFV) both by themselves and when nelfinavir (NFV),...” PMID 16048950 ↗ Aug 200510“The purpose of this study is to see if it is safe and effective to give the protease inhibitor (PI) amprenavir (APV) to patients with fat production and distribution problems...” NCT00002417 ↗ “The other anti-HIV drugs used are abacavir (ABC), amprenavir (APV), ritonavir (RTV), and efavirenz (EFV).” NCT00002239 ↗ “The purpose of this study is to see if it is safe to give amprenavir (APV) to HIV-infected patients.” NCT00002405 ↗ “Arm A, B, C, and D: Patients receive indinavir (IDV), amprenavir (APV), ddI, and hydroxyurea (HU).” NCT00000919 ↗ “Amprenavir (APV) is an attractive candidate to investigate as part of salvage regimens” NCT00000912 ↗ “3TC/ABC/amprenavir (APV)/ritonavir (RTV)” NCT00005017 ↗ “saquinavir (SQV) or amprenavir (APV)” NCT00046033 ↗ “Accepted PIs: amprenavir (APV).” NCT00039741 ↗ “141W94 (amprenavir [APV])” NCT00006617 ↗ “amprenavir (APV)” NCT00002419 ↗ |
| Known as | J05AE05 | ChEMBL registry synonym — accepted as the source's own label CHEMBL116 ↗ |
| Known as | KVX-478 | ChEMBL registry synonym — accepted as the source's own label CHEMBL116 ↗ |
| Known as | VX478 | “A Phase II Study of 1) Amprenavir (141W94/VX478) Plus 3TC Plus ZDV (or d4T) or 2) IDV Plus NVP Plus 3TC Plus d4T in Subjects Previously Treated With Amprenavir and 3) Other...” NCT00001095 ↗ |
| Action | Inhibit | “experimental protease inhibitor (PI), amprenavir” NCT00000912 ↗ |
| Modality | Other / unclassified | “Protease Inhibitor” NCT00000919 ↗ |
| Route | Oral | “amprenavir 1200 mg po BID” NCT00001766 ↗ |