Saquinavir
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Invirase | — | 2023-08-16 | europa.eu ↗ |
| Label expansions (2) | US (FDA) | INVIRASE | — | 1996-09-27 – 2012-11-30 | fda.gov ↗ |
| Label expansion | US (FDA) | FORTOVASE | — | 2003-12-24 | fda.gov ↗ |
| Approved | EU (EMA) | Invirase | — | 1996-10-03 | europa.eu ↗ |
| Approved | US (FDA) | INVIRASE | — | 1995-12-06 | fda.gov ↗ |
Trials 63
Evidence & citations 20 cited values
Every value below carries the sentence it was read from. 87 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Saquinavir | “Generic names: Efavirenz/Emtricitabine/Tenofovir, Lamivudine/Zidovudine, Emtricitabine, Lamivudine, Abacavir/Lamivudine, Zidovudine, Abacavir/Lamivudine/Zidovudine,...” NCT00624195 ↗79“It may include one or two nucleoside reverse transcriptase inhibitors, such as zidovudine, didanosine, lamuvidine, zalcitabine, stavudine), a non- nucleoside reverse...” NCT00032669 ↗ “Any approved antiretroviral protease inhibitor such as atazanavir, darunavir, indinavir, ritonavir, and saquinavir ; consistent with the most recent prescribing information documents” NCT02556268 ↗ “Tenofovir+Emtricitabine+Third agent (Including a ritonavir-boosted protease inhibitor : saquinavir or indinavir or fosamprenavir or tipranavir or darunavir or atazanavir or lopinavir” NCT02302547 ↗ “Protease inhibitors (PIs) included amprenavir, atazanavir, darunavir, fosamprenavir, Kaletra (lopinavir/ritonavir, coformulated), ritonavir, and saquinavir.” NCT01252940 ↗ “allowed PIs include atazanavir (ATV), darunavir (DRV), fosamprenavir (FPV), lopinavir (LPV), or saquinavir (SQV)” NCT01475838 ↗ “saquinavir (SQV; Invirase®; Fortovase®) + RTV” NCT02616783 ↗ “nelfinavir mesylate (NFV), saquinavir (SQV)” NCT00039741 ↗ “saquinavir (SQV; Invirase®) + RTV” NCT02605954 ↗ “saquinavir [SQV]” NCT00665847 ↗ “saquinavir (SQV)” NCT03631732 ↗ |
| Known as | Fortovase | “An Exploratory Study of Fortovase (Saquinavir) Soft Gelatin Capsules (SGC) Plus d4T and 3TC or Fortovase (Saquinavir) SGC Plus Nelfinavir and d4T in Patients With HIV-1...” NCT00002397 ↗7“Evaluation of Immune Reconstitution in HIV Infected Patients Treated With Fortovase (Saquinavir) SGC QD Plus Ritonavir QD Plus 2 NRTIs Vs Efavirenz QD Plus 2 NRTIs” NCT00002448 ↗ “Fortovase (Saquinavir) Given With Low-Dose Ritonavir, Zidovudine, and Lamivudine to HIV-Positive Pregnant Women During and After Pregnancy and to Their Newborns” NCT00000920 ↗ “Fortovase (FTV) (Saquinavir) Soft Gel Capsule (SGC)” NCT00002378 ↗ “FORTOVASE (Saquinavir) Soft Gel Capsule (SGC)” NCT00002229 ↗ “saquinavir (SQV; Invirase®; Fortovase®) + RTV” NCT02616783 ↗ “Saquinavir-sgc (Fortovase®)” NCT02184286 ↗ “Fortovase (Saquinavir)” NCT00002447 ↗ |
| Known as | FTV | “Fortovase (FTV) (Saquinavir) Soft Gel Capsule (SGC)” NCT00002378 ↗ |
| Known as | INV | “saquinavir mesylate (INV)” NCT00043953 ↗ |
| Known as | Invirase | “The Pharmacokinetics of SAquinavir (Invirase New Tablet Formulation) 1,000mg + Ritonavir (Norvir) 100mg q12h in HIV-infected Pregnant Women (SARA)” NCT00145561 ↗5“saquinavir (SQV; Invirase®; Fortovase®) + RTV” NCT02616783 ↗ “saquinavir (SQV; Invirase®) + RTV” NCT02605954 ↗ “saquinavir [Invirase]” NCT00623597 ↗ “saquinavir [Invirase]” NCT01638650 ↗ |
| Known as | Ro 31-8959 | “To compare the safety, tolerance, and efficacy of saquinavir mesylate (Ro 31-8959) alone, zalcitabine (dideoxycytidine; ddC) alone, and both in combination, in patients...” NCT00002333 ↗5“To investigate the toxicity, antiviral activity, and pharmacokinetics in HIV-infected patients receiving 16 weeks of oral saquinavir mesylate ( Ro 31-8959 ) at one of two doses.” NCT00002111 ↗ “Specifically, to evaluate zidovudine/zalcitabine ( AZT / ddC ) alone or in combination with either nevirapine or saquinavir ( Ro 31-8959 ).” NCT00002347 ↗ “Saquinavir Mesylate (Ro 31-8959 ; HIV Proteinase Inhibitor)” NCT00002334 ↗ “saquinavir mesylate (Ro 31-8959)” NCT00001040 ↗ “Saquinavir HGC (Ro 31-8959)” NCT00002374 ↗ |
| Known as | RO 31-8959/000 | ChEMBL registry synonym — accepted as the source's own label CHEMBL114 ↗ |
| Known as | RO 31-8959/003 | ChEMBL registry synonym — accepted as the source's own label CHEMBL114 ↗ |
| Known as | Saquinavir HGC | “saquinavir HGC (hard gel capsules)” NCT00002374 ↗ |
| Known as | Saquinavir mesilate | ChEMBL registry synonym — accepted as the source's own label CHEMBL114 ↗ |
| Known as | saquinavir mesylate | “To compare the safety, tolerance, and efficacy of saquinavir mesylate (Ro 31-8959) alone, zalcitabine (dideoxycytidine; ddC) alone, and both in combination, in patients...” NCT00002333 ↗3“To investigate the toxicity, antiviral activity, and pharmacokinetics in HIV-infected patients receiving 16 weeks of oral saquinavir mesylate ( Ro 31-8959 ) at one of two doses.” NCT00002111 ↗ “Saquinavir Mesylate (Ro 31-8959 ; HIV Proteinase Inhibitor)” NCT00002334 ↗ “saquinavir mesylate (Ro 31-8959)” NCT00001040 ↗ |
| Known as | Saquinavir methanesulfonate salt | ChEMBL registry synonym — accepted as the source's own label CHEMBL114 ↗ |
| Known as | Saquinavir SGC | “The purpose of this study is to see if it is safe to give saquinavir-SGC (SQV) combined with low-dose ritonavir (RTV) plus zidovudine (ZDV) and lamivudine (3TC) to HIV-positive...” NCT00000920 ↗3“An Open-Label, Non-Comparative Study of Saquinavir-SGC in Combination With Zidovudine (AZT) and Lamivudine (3TC) in the Treatment of HIV-1 Infected Patients With No Previous...” NCT00002367 ↗ “saquinavir SGC (soft gel capsules)” NCT00002374 ↗ “Saquinavir-sgc (Fortovase®)” NCT02184286 ↗ |
| Known as | Saquinavirum | ChEMBL registry synonym — accepted as the source's own label CHEMBL114 ↗ |
| Known as | SCH-52852 | ChEMBL registry synonym — accepted as the source's own label CHEMBL114 ↗ |
| Known as | SQV | “This study aimed to assess the long-term efficacy, safety and use of therapeutic drug monitoring (TDM) of a double-boosted protease inhibitor (PI) combination, saquinavir (SQV)...” PMID 19430099 ↗ 200923“The purpose of this study is to see if it is safe to give saquinavir-SGC (SQV) combined with low-dose ritonavir (RTV) plus zidovudine (ZDV) and lamivudine (3TC) to HIV-positive...” NCT00000920 ↗ “This 48-week randomized study examined the safety and efficacy of a switch in CART to a once-daily regimen of saquinavir (SQV), ritonavir (RTV), and atazanavir (ATV) that did...” PMID 17479946 ↗ Apr 2007 “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 2005 “saquinavir/ritonavir 1500/100 mg or 1500/50 mg Twenty HIV-infected volunteers on stable doses of SQV/RTV 1500/100 mg OD for at least 3 months with an NRTI backbone and...” NCT00622206 ↗ “The 7 drugs that will be given in this study are stavudine (d4T), didanosine (ddI), lamivudine (3TC), nelfinavir (NFV), ritonavir (RTV), saquinavir (SQV), and nevirapine (NVP).” NCT00001108 ↗ “the combination of the HIV protease inhibitors (HIV-PIs) saquinavir and ritonavir (SQV+RIT) in patients with idiopathic pulmonary arterial hypertension (IPAH)” PMID 26401255 ↗ Sep 2015 “Efficacy and safety of a saquinavir (SQV) based regimen in HIV-1 infected Thai patients who have chronic indinavir (IDV) associated nephrotoxicity.” NCT00477048 ↗ “allowed PIs include atazanavir (ATV), darunavir (DRV), fosamprenavir (FPV), lopinavir (LPV), or saquinavir (SQV)” NCT01475838 ↗ “lopinavir/ritonavir (LPV/r), saquinavir (SQV), and the NRTIs emtricitabine (FTC) and abacavir sulfate (ABC)” NCT00102206 ↗ “Arm A: Saquinavir (SQV) plus ritonavir (RTV) plus delavirdine (DLV) plus adefovir dipivoxil placebo.” NCT00000892 ↗ |
| Known as | SQV-SGC | “Arm A: APV plus saquinavir soft gel capsule (SQVsgc) plus abacavir (ABC) plus efavirenz (EFV) plus adefovir (ADV).” NCT00000912 ↗1“saquinavir soft gelatin capsule formulation (SQV-SGC)” NCT00002425 ↗ |
| Action | Inhibit | “other protease inhibitors (saquinavir/nelfinavir or saquinavir/ritonavir)” NCT00000892 ↗ |
| Modality | Small molecule | — CHEMBL114 ↗ |
| Route | Oral | “oral saquinavir mesylate” NCT00002111 ↗ |