Nelfinavir
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Viracept | — | 2013-01-23 | europa.eu ↗ |
| Label expansions (3) | US (FDA) | VIRACEPT | — | 1999-11-24 – 2004-03-19 | fda.gov ↗ |
| Approved | EU (EMA) | Viracept | — | 1998-01-22 | europa.eu ↗ |
| Approved | US (FDA) | VIRACEPT | — | 1997-03-14 | fda.gov ↗ |
Trials 119 · started per year
Also used as a comparator or background therapy in 16 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00000899 Background | ? → Oct 2001 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT00006211 Background | Feb 2000 → Apr 2001 | HIV infectious disease | Agouron Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00004985 Background | Jan 2000 → ? | HIV infectious disease | Agouron Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00004998 Background | Nov 1999 → ? | HIV infectious disease | Agouron Pharmaceuticals | Suspended | No outcome recorded |
| Phase 2 | NCT00004999 Background | Aug 1999 → ? | HIV infectious disease | Agouron Pharmaceuticals | Suspended | No outcome recorded |
| Phase 2 | NCT00002442 Background | Jun 1999 → ? | HIV infectious disease | Glaxo Wellcome | Completed | No outcome recorded |
| Phase 2 | NCT00001122 Background | ? → Oct 2003 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT03631732 Comparator | Aug 2018 → Aug 2019 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT00234091 Comparator | Apr 2006 → Sep 2011 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 3 | NCT00650637 Background | Jan → Aug 2003 | diarrheal disease | Pfizer | Terminated | No outcome recorded |
| Phase 3 | NCT00002429 Background | Jul 1999 → Jan 2001 | HIV infectious disease | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT00002224 Background | Mar 1999 | HIV infectious disease | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT00005002 Background | — | HIV infectious disease | Agouron Pharmaceuticals | Unknown | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT00457665 Comparator | Feb 2002 → Oct 2007 | HIV infectious disease | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT00006441 Background | Feb 2003 → Oct 2008 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| — | NCT00002215 Background | — | HIV infectious disease | Triangle Pharmaceuticals | Completed | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2004-01-20 | Vertex Pharmaceuticals Incorporated | Phase III, 48-Week NEAT Study Results Comparing LEXIVA(TM) to Nelfinavir Published in the Journal of Acquired Immune Deficiency Syndrome (JAIDS) vrtx.com ↗ |
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 142 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | nelfinavir | “Generic names: Efavirenz/Emtricitabine/Tenofovir, Lamivudine/Zidovudine, Emtricitabine, Lamivudine, Abacavir/Lamivudine, Zidovudine, Abacavir/Lamivudine/Zidovudine,...” NCT00624195 ↗126“It may include one or two nucleoside reverse transcriptase inhibitors, such as zidovudine, didanosine, lamuvidine, zalcitabine, stavudine), a non- nucleoside reverse...” NCT00032669 ↗ “receive individualized regimen of HAART for 48 weeks: nelfinavir (NEV), nevirapine (NVP), and nucleoside reverse transcriptase inhibitor(s) as per primary physician.” NCT00000895 ↗ “The HIV protease inhibitor nelfinavir (NFV) displays notable radiosensitizing effects.” PMID 30825970 ↗ Dec 2018 “nelfinavir (NFV) and efavirenz (EFV) when used in combination or separately” NCT00001087 ↗ “nelfinavir (NLV)” NCT00336778 ↗ “nelfinavir NFV)” NCT03631732 ↗ |
| Known as | A430 | “A Phase Iv Single-Arm Open-Label Non-Randomized Study To Evaluate The Safety And Pharmacokinetics Of Nelfinavir (Viracept, A430) 1250mg Twice Daily (250mg Or 625mg Forms) With...” NCT00141284 ↗ |
| Known as | AG-1343 | ChEMBL registry synonym — accepted as the source's own label CHEMBL584 ↗ |
| Known as | Nelfinavir mesilate | ChEMBL registry synonym — accepted as the source's own label CHEMBL584 ↗ |
| Known as | Nelfinavir mesylate | “The purpose of this study is to see if the addition of capravirine to VIRACEPT (nelfinavir mesylate) plus 2 nucleoside reverse transcriptase inhibitors (NRTIs) is an effective...” NCT00006211 ↗20“This is a single-institution, single-arm study with a safety lead-in to determine if previously established safe doses of autophagy drugs, hydroxychloroquine (HCQ) and...” NCT06971744 ↗ “Viracept (Nelfinavir Mesylate) 1250 Mg BID, Crixivan (Indinavir Sulfate) 1200mg q12h, and Sustiva (Efavirenz; DMP-266) 600 Mg q24h” NCT00002235 ↗ “VIRACEPT® (nelfinavir mesylate) is an inhibitor of the human immunodeficiency virus (HIV) protease.” NCT02024009 ↗ “To make nelfinavir mesylate (Viracept) available for treatment of HIV positive patients” NCT00002165 ↗ “Nelfinavir mesylate (Viracept) is an inhibitor of the HIV protease 1.” NCT01555281 ↗ “Viracept (Nelfinavir Mesylate)” NCT00004999 ↗ “Drug: Nelfinavir Mesylate” NCT03077451 ↗ “nelfinavir mesylate (NFV)” NCT00039741 ↗ “Nelfinavir mesylate” NCT00002201 ↗ “Nelfinavir mesylate” NCT00000887 ↗ |
| Known as | Nelfinavir methanesulfonate | ChEMBL registry synonym — accepted as the source's own label CHEMBL584 ↗ |
| Known as | Nelfinaviri mesilas | ChEMBL registry synonym — accepted as the source's own label CHEMBL584 ↗ |
| Known as | NEV | “receive individualized regimen of HAART for 48 weeks: nelfinavir (NEV), nevirapine (NVP), and nucleoside reverse transcriptase inhibitor(s) as per primary physician.” NCT00000895 ↗ |
| Known as | NFV | “The purpose of this study is to assess the impact of prospective drug level monitoring and dose-adjustment of nelfinavir (NFV) on the clinical and virologic outcomes in a group...” NCT00205283 ↗35“Patients 18 years of age and older with clinical stages IIA, IIB, IIIA, IIIB, IVA cervical carcinoma limited to the pelvis will receive twice daily oral nelfinavir (NFV) and...” NCT02363829 ↗ “This is a single-institution, single-arm study with a safety lead-in to determine if previously established safe doses of autophagy drugs, hydroxychloroquine (HCQ) and...” NCT06971744 ↗ “This is a phase 2 trial of the HIV protease inhibitor (HPI) Nelfinavir (NFV) in combination with radiotherapy and chemotherapy in patients with locally advanced non-small cell...” NCT00791336 ↗ “In Pediatric AIDS Clinical Trials Group 377, antiretroviral therapy-experienced children were randomized to 4 treatment arms that included different combinations of stavudine,...” PMID 11372025 ↗ May 2001 “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 “Each regimen consists of 4 drugs that include a combination of nucleoside reverse transcriptase inhibitors (stavudine, lamivudine, zidovudine, didanosine, zalcitabine) plus...” NCT00000902 ↗ “either nelfinavir (NFV) 30 mg/kg twice daily (bid), ritonavir (RTV) 400 mg/m bid and buffered didanosine (ddI) 240 mg/m daily (arm A) or NFV 50-55 mg/kg bid, nevirapine (NVP)...” PMID 16220085 ↗ Oct 2005 “Nelfinavir (NFV), an FDA-approved protease inhibitor for the treatment of HIV, has been shown to be a potent activator of lytic gene expression of EBV(+) and KSHV(+) cancer cell lines.” NCT02080416 ↗ “Patients receive specific combinations of 3 or 4 of the following 6 drugs: didanosine (ddI), stavudine (d4T) efavirenz (EFV), nelfinavir (NFV), lamivudine (3TC), or zidovudine (ZDV).” NCT00000919 ↗ “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 ↗ “PURPOSE: To compare the long-term clinical efficacy and toxicity of initial strategies of nelfinavir (NFV) or ritonavir (RTV) in patients with CD4+ cells below 200/mm3.” PMID 15002082 ↗ Jan 2004 “The purpose of this study is to see if it is safe and effective to treat HIV-infected patients with indinavir (IDV) plus nelfinavir (NFV), 2 anti-HIV medications.” NCT00002375 ↗ “The purpose of this study is to evaluate the FDA-approved drug nelfinavir (NFV) as an oncologic agent for adenoid cystic cancers of the head and neck.” NCT01065844 ↗ “In Step 1 of this 2-step protocol, all patients receive a HAART regimen of nelfinavir (NFV) plus stavudine (d4T) plus lamivudine (3TC).” NCT00000899 ↗ “Group 1 receives GW433908 plus abacavir (ABC) plus lamivudine (3TC); Group 2 receives nelfinavir (NFV) plus ABC plus 3TC.” NCT00008554 ↗ “Nelfinavir (NFV) induces cell cycle arrest, endoplasmic reticulum stress, autophagy, and apoptosis is cancer cells.” NCT01925378 ↗ “certain anti-HIV drugs (efavirenz \[EFV\] and nelfinavir \[NFV\]) affect the amount of certain fat-lowering drugs” NCT00017758 ↗ “GW433908/ritonavir (RTV) to viral response to nelfinavir (NFV) when used with abacavir (ABC)/lamivudine (3TC)” NCT00009061 ↗ “The study-specified PIs will be indinavir (IDV), nelfinavir (NFV), or two PIs of patient and doctor choice.” NCT00000922 ↗ “BACKGROUND: Combination antiretroviral regimens including nelfinavir (NFV) are commonly used in pregnancy.” PMID 18474496 ↗ Mar 2008 “The HIV protease inhibitor nelfinavir (NFV) displays notable radiosensitizing effects.” PMID 30825970 ↗ Dec 2018 “Group 1 receives delavirdine (DLV) plus nelfinavir (NFV) plus stavudine (d4T).” NCT00002211 ↗ “nelfinavir (NFV) and efavirenz (EFV) when used in combination or separately” NCT00001087 ↗ “Arm D: SQV plus nelfinavir (NFV) plus DLV plus adefovir dipivoxil placebo.” NCT00000892 ↗ “Arm C: APV plus nelfinavir (NFV) plus ABC plus EFV plus ADV.” NCT00000912 ↗ “efavirenz (EFZ) and nelfinavir (NFV)” NCT00000893 ↗ “another PI, nelfinavir (NFV).” NCT00004583 ↗ “Nelfinavir (NFV) plus EFV.” NCT00000914 ↗ “Drug: Nelfinavir (NFV)” NCT00099359 ↗ “nelfinavir [NFV]” NCT00028327 ↗ “nelfinavir (NFV)” NCT00001122 ↗ “nelfinavir (NFV)” NCT00006443 ↗ “nelfinavir (NFV)” NCT00005000 ↗ “Nelfinavir (NFV)” NCT00001094 ↗ “nelfinavir NFV)” NCT03631732 ↗ |
| Known as | NLF | “The drugs used in this study are delavirdine (DLV), nelfinavir (NLF), didanosine (ddI), and stavudine (d4T).” NCT00002211 ↗1“Both forms of ddI will be given with stavudine (d4T) plus nelfinavir (NLF).” NCT00002224 ↗ |
| Known as | NLV | “nelfinavir (NLV)” NCT00336778 ↗ |
| Known as | NSC-747167 | ChEMBL registry synonym — accepted as the source's own label CHEMBL584 ↗ |
| Known as | Viracept | “A Phase Iv Single-Arm Open-Label Non-Randomized Study To Evaluate The Safety And Pharmacokinetics Of Nelfinavir (Viracept, A430) 1250mg Twice Daily (250mg Or 625mg Forms) With...” NCT00141284 ↗10“The purpose of this study is to see if the addition of capravirine to VIRACEPT (nelfinavir mesylate) plus 2 nucleoside reverse transcriptase inhibitors (NRTIs) is an effective...” NCT00006211 ↗ “An Investigation of the Potential Pharmacokinetic Interaction Between Nevirapine (Viramune) and Nelfinavir (Viracept) and the Efficacy of This Combination Therapy in HIV-1...” NCT00002381 ↗ “A Phase I Trial of the Safety, Tolerance, and Pharmacokinetics of Oral Nelfinavir (Viracept) Co-Administered With Zidovudine (ZDV) and Lamivudine (3TC) in HIV Infected Pregnant...” NCT00000887 ↗ “Viracept (Nelfinavir Mesylate) 1250 Mg BID, Crixivan (Indinavir Sulfate) 1200mg q12h, and Sustiva (Efavirenz; DMP-266) 600 Mg q24h” NCT00002235 ↗ “These patients are eligible to receive funding for up to a 3-month supply of nelfinavir (Viracept) and Combivir.” NCT00005002 ↗ “To make nelfinavir mesylate (Viracept) available for treatment of HIV positive patients” NCT00002165 ↗ “Viracept (Nelfinavir Mesylate)” NCT00004999 ↗ “Nelfinavir (Viracept®) 1250 mg” NCT02207439 ↗ “nelfinavir (Viracept)” NCT00002215 ↗ “Viracept (nelfinavir)” NCT00004998 ↗ |
| Action | Inhibit | “other protease inhibitors (saquinavir/nelfinavir or saquinavir/ritonavir)” NCT00000892 ↗ |
| Modality | Other / unclassified | “Protease Inhibitor” NCT00000919 ↗ |
| Route | Oral | “Oral Nelfinavir” NCT00000887 ↗ |