nelfinavir

Trade name: viracept

Small moleculeapproved

Approved

Mar 14, 1997

Nelfinavir is a protease inhibitor with activity against Human Immunodeficiency Virus Type 1 (HIV-1). Protease inhibitors block the part of HIV called protease. HIV-1 protease is an enzyme required for the proteolytic cleavage of the viral polyprotein precursors into the individual functional proteins found in infectious HIV-1. Nelfinavir binds to the protease active site and inhibits the activity of the enzyme. This inhibition prevents cleavage of the viral polyproteins resulting in the formation of immature non-infectious viral particles. Protease inhibitors are almost always used in combination with at least two other anti-HIV drugs. Nelfinavir inhibits the HIV viral proteinase enzyme which prevents cleavage of the gag-pol polyprotein, resulting in noninfectious, immature viral particles. Nelfinavir is used in combination with other antiviral drugs in the treatment of HIV in both adults and children. Nelfinavir is marketed under the brand name Viracept. — NCATS

Clinical trial activity

135 trials · 71 clinical orgs · 2 marketing orgs

Phase 1
44
Phase 2
64
Phase 3
20
Phase 4
11

Earliest trial started May 1, 1997 (NCT00002177)

Timeline

1990s

  1. Jun 1, 1995

    Agouron — IND Organization

  2. Jun 1, 1995

    Agouron — IND Organization

  3. Jan 1, 1997

    Earliest Phase 1 Sponsor(trial)

  4. Jan 1, 1997

    Earliest Phase 2 Sponsor(trial)

  5. Mar 14, 1997

    Agouron — Earliest FDA Approval

  6. Mar 14, 1997

    Agouron — NDA Organization

  7. Jan 1, 1999

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Apr 30, 2003

    Pfizer — NDA Secondary Org

Indications

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewAcceleratedMar 14, 1997

Chemistry & pharmacology

Loading structure…

SMILES

Cc1c(O)cccc1C(=O)N[C@@H](CSc1ccccc1)[C@H](O)CN1C[C@H]2CCCC[C@H]2C[C@H]1C(=O)NC(C)(C)C
Mol. weight
567.8 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • ag-1343
  • ag-1343
  • nelfinavir
  • nelfinavir
  • nelfinavir
  • nelfinavir
  • nelfinavir
  • nelfinavir
  • nelfinavir
  • nelfinavir
  • nelfinavir
  • nelfinavir
  • nelfinavir
  • nelfinavir
  • nelfinavir mesilate
  • nelfinavir mesilate
  • nelfinavir mesilate
  • nelfinavir mesylate
  • nelfinavir mesylate
  • nelfinavir mesylate
  • nelfinavir mesylate
  • viracept
  • viracept
  • viracept
  • viracept

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06971744Phase 2Jan 1, 2026Medical University of South Carolina
NCT07281781Phase 1/Phase 2 (Phase 2)Sep 16, 2025Chao Family Comprehensive Cancer Center, University of California, Irvine
NCT05036226Phase 1/Phase 2 (Phase 2)Jan 15, 2022Medical University of South Carolina
NCT04169763Phase 1Mar 30, 2020National Cancer Institute (NCI), University of Texas at Houston
NCT03829020Phase 1Apr 17, 2019Mayo Clinic, National Cancer Institute (NCI)
NCT03631732Phase 3Aug 28, 2018Gilead Sciences
NCT03256916Phase 3Sep 25, 2017Tata Memorial Hospital
NCT03050060Phase 2Jun 9, 2017National Cancer Institute (NCI), University of Washington
NCT03077451Phase 2Mar 13, 2017AIDS and Cancer Specimen Resource, AIDS Malignancy Consortium, Hoosier Cancer Research Network, National Cancer Institute (NCI), The EMMES Corporation, University of California, Los Angeles
NCT03422874Phase 1Aug 31, 2016Dartmouth University
NCT02024009Phase 1/Phase 2 (Phase 2)Mar 1, 2016Cancer Research UK, Celgene, University of Oxford
NCT02363829Phase 1Feb 1, 2015University of Pennsylvania
NCT02858401Phase 1Jan 29, 2015Gilead Sciences
NCT02188537Phase 2Dec 1, 2014Cantonal Hospital of St. Gallen, Swiss Group for Clinical Cancer Research
NCT02066311Phase 2Sep 1, 2014National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Northwell Health
NCT02080416Early Phase 1 (Phase 1)Jul 1, 2014Johns Hopkins University
NCT02207439Phase 2Jul 1, 2014University of Pennsylvania
NCT01959672Phase 2Sep 1, 2013National Cancer Institute (NCI), University of Nebraska
NCT01728779Phase 2Apr 1, 2013Johns Hopkins University
NCT01925378Phase 2Jul 1, 2012The University of Texas Health Science Center, Houston, University of Texas at Houston
Showing 20 of 135 trials
Page 1 / 7

Organizations

Research & Development (71)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Institute of Allergy and Infectious Diseases (NIAID)Government353441997
AgouronFor profit151251999
National Cancer Institute (NCI)Government10121997
National Institutes of Health (NIH)Government10141997
Glaxo WellcomeFor profit9851999
Bristol-Myers SquibbFor profit8741997
RocheFor profit7641999
University of PennsylvaniaAcademic/Hospital6622007
Gilead SciencesFor profit5531999
PfizerFor profit5522003
Mayo ClinicAcademic/Hospital4412003
MerckFor profit4421999
Cantonal Hospital of St. GallenAcademic/Hospital3022010
Swiss Group for Clinical Cancer ResearchAcademic/Hospital3322010
University of IowaAcademic/Hospital3322008
University of WashingtonAcademic/Hospital3122002
AbbottFor profit2221999
AIDS Malignancy ConsortiumAcademic/Hospital2111997
Boehringer IngelheimFor profit2211999
Duke UniversityAcademic/Hospital2021999
71 organizations
Page 1 / 4

Marketing (4)

OrganizationOrg typeRelationshipDate
AgouronFor profitSYNMar 14, 1997
AgouronFor profitNDAMar 14, 1997
AgouronFor profitINDJun 1, 1995
PfizerFor profitNDA2Apr 30, 2003