Viracept

(Nelfinavir)

ApprovedSmall molecule

Viracept is a small molecule that works as a Human Immunodeficiency Virus Type 1 Protease Inhibitor.[2] It is being used across 11 indications, with its most advanced program in Approved.[1]

Viracept is one of 326 small molecule programs targeting Viral Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

325

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Viral DiseaseActive, not recruiting

Lung CancerApproved

ParagangliomaApproved

Glioblastoma MultiformeApproved

Dysplasia of CervixApproved

HIV InfectionApproved

HIV-1 InfectionActive, not recruiting

LipodystrophyActive, not recruiting

Radiation TherapyRecruiting

MyelofibrosisRecruiting

Viral DiseaseApproved

Active, not recruiting

Lung CancerApproved

Approved

ParagangliomaApproved

Approved

Glioblastoma MultiformeApproved

Approved

Dysplasia of CervixApproved

Approved

HIV InfectionApproved

Approved

HIV-1 InfectionPreclinical

Active, not recruiting

LipodystrophyApproved

Active, not recruiting

Radiation TherapyPhase 1

Recruiting

MyelofibrosisPhase 2

Recruiting

Showing 10 of 11 indications

Competition

Competitive Landscape

206 competitors in Lung Cancer

#DrugCompanyPhaseTrials

Viracept

AAgouron Pharmaceuticals

Approved

37 2

Keytruda

Merck & Co.

Phase 3

33 3

Opdivo

Bristol-Myers Squibb

Phase 3

20 4

Tagrisso

AstraZeneca

Phase 3

19 5

Beyfortus

BeiGene

Phase 3

10 6

Yervoy

Bristol-Myers Squibb

Phase 3

10 7

Alunbrig

Takeda

Phase 3

4 8

Alecensa

Roche

Phase 3

3 9

DATROWAY

Daiichi Sankyo

Phase 3

2 10

Tarlatamab-Dznl

Amgen

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Recruiting

Radiation Therapy

NCT04169763

Q2 2027

Phase 1/2Recruiting

Myelofibrosis

NCT07281781

Q2 2029

Phase 2Recruiting

AIN

NCT06971744

Clinical

Trials by Indication[1]

Pancreatic Cancer2 trials

Evaluation of Nelfinavir and Chemoradiation for Pancreatic Cancer

Terminated·UUniversity of Iowa·Phase 1·NCT01086332·7 enrolled

Systemic Therapy and Chemoradiation in Advanced Localised Pancreatic Cancer - 2

Completed·UUniversity of Oxford·Phase 1/2·NCT02024009·159 enrolled

Cervical Cancer2 trials

A Study of Nelfinavir Added to Cisplatin Chemotherapy Concurrent With Pelvic Radiation for Locally Advanced Cervical Cancer (II-IVA)

Completed·—·Phase 1·NCT02363829·6 enrolled

Safety Study of Nelfinavir + Cisplatin + Pelvic Radiation Therapy to Treat Cervical Cancer

Completed·UUniversity of Miami·Phase 1·NCT01485731·8 enrolled

Sepsis1 trial

The Effects of HIV Protease Inhibitors in Severe Sepsis

Completed·MMayo Clinic·Phase 1·NCT00346580·60 enrolled

AIN1 trial

Autophagy Maintenance (AUTOMAIN)

Recruiting·MMedical University of South Carolina·Phase 2·NCT06971744·38 enrolled

Drug Monitoring1 trial

Evaluation of Therapeutic Drug Monitoring of Protease Inhibitors on Virologic Success and Tolerance of Highly Active Antiretroviral Therapy (HAART)

Terminated·FFrench National Agency for Research on AIDS and Viral Hepatitis·N/A·NCT00122590·115 enrolled

30 more indications

Children1 trial

When to Start Anti-HIV Drugs in Children Infected With HIV (The PREDICT Study)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00234091·300 enrolled

Myelofibrosis1 trial

Treating Anemia in Myelofibrosis With Repurposed Drugs (Nelfinavir) That Restore Iron Delivery to the Bone Marrow

Recruiting·UUniversity of California, Irvine·Phase 1/2·NCT07281781·10 enrolled

Lipodystrophy1 trial

Mechanisms of Lipodystrophy in HIV-Infected Pateints

Completed·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT00457665·56 enrolled

Rectal Cancer1 trial

Nelfinavir, a Phase I/Phase II Rectal Cancer Study

Completed·MMaastricht Radiation Oncology·Phase 1/2·NCT00704600·15 enrolled

Squamous Cell Carcinoma1 trial

Phase II Trial of Nelfinavir With Concurrent Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck

Completed·—·Phase 2·NCT02207439·18 enrolled

Prevention1 trial

Trial of Three Neonatal Antiretroviral Regimens for Prevention of Intrapartum HIV Transmission

Completed·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 3·NCT00099359·1,735 enrolled

Small Cell Lung Cancer1 trial

Proton Beam Radiation With Concurrent Chemotherapy and Nelfinavir for Inoperable Stage III Non Small Cell Lung Cancer (NSCLC)

Terminated·—·Phase 2·NCT01108666·7 enrolled

Locally Advanced1 trial

Radiosensitizing Effect of Nelfinavir in Locally Advanced Carcinoma of Cervix

Completed·TTata Memorial Hospital·Phase 3·NCT03256916·348 enrolled

Cancer of the Head and Neck1 trial

Nelfinavir in Recurrent Adenoid Cystic Cancer of the Head and Neck

Completed·UUniversity of Iowa·Phase 2·NCT01065844·15 enrolled

Drug1 trial

Study to Determine the Pharmacokinetic Behavior of Antiretroviral Drugs in Patients Infected by HIV

Completed·GGermans Trias i Pujol Hospital·Phase 1·NCT00307502·675 enrolled

HIV infection1 trial

HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA001)

Completed·KKirby Institute·Phase 4·NCT00192660·80 enrolled

Interaction1 trial

TBTC Study 23B:Intensive PK of the Nelfinavir Rifabutin Interaction in Patients With HIV-TB

Completed·CCenters for Disease Control and Prevention·Phase 4·NCT00023400·20 enrolled

Tics1 trial

Effect of Different Boosting Agents on Pharmacokinetics of BILR 355 BS Dissolved in Polyethylene Glycol 400 (PEG 400) in Healthy Male Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02257008·44 enrolled

Treatment1 trial

Nelfinavir for the Treatment of Gammaherpesvirus-Related Tumors

Terminated·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT02080416·1 enrolled

Glioblastoma1 trial

Study With Nelfinavir and Combined Radiochemotherapy for Glioblastoma

Completed·MMaastricht Radiation Oncology·Phase 1·NCT00694837·6 enrolled

Oligometastases1 trial

Stereotactic Body Radiation With Nelfinavir for Oligometastases

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT01728779·38 enrolled

Non-Small Cell Lung Cancer1 trial

Study to Evaluate Using Nelfinavir With Chemoradiation for Non-small Cell Lung Cancer

Terminated·UUniversity of Iowa·Phase 2·NCT00791336·1 enrolled

Diarrhea1 trial

A Study to Determine Effective Prophylaxis and Treatment of Nelfinavir-Associated Diarrhea

Terminated· Pfizer logo

Pfizer·Phase 3·NCT00650637·17 enrolled

Immune System1 trial

Determining the Amount of Time Needed for Nelfinavir to Boost the Immune System in Adults

Completed·MMayo Clinic·Phase 1·NCT00346619·25 enrolled

Cervical Intraepithelial Neoplasia1 trial

A Phase II Single-arm Intervention Trial of Nelfinavir in Patients With Grade 2/3 or 3 Cervical Intraepithelial Neoplasia

Withdrawn·TThe University of Texas Health Science Center, Houston·Phase 2·NCT01925378

Glioma1 trial

A Trial of the Protease Inhibitor Nelfinavir and Concurrent Radiation and Temozolomide in Patients With WHO Grade IV Glioma

Completed·—·Phase 1·NCT01020292·31 enrolled

Radiotherapy1 trial

Radical Lung Radiotherapy Plus Nelfinavir

Withdrawn·OOxford University Hospitals NHS Trust·Phase 1/2·NCT01447589

Radiation Therapy1 trial

Nelfinavir, Cisplatin, and External Beam Radiation Therapy for the Treatment of Locally Advanced Vulvar Cancer That Cannot Be Removed by Surgery

Recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT04169763·25 enrolled

Myeloma1 trial

Nelfinavir as Bortezomib-sensitizing Drug in Patients With Proteasome Inhibitor-nonresponsive Myeloma

Completed·SSwiss Cancer Institute·Phase 2·NCT02188537·34 enrolled

Systemic Lupus Erythematosus1 trial

Nelfinavir in Systemic Lupus Erythematosus

Terminated·NNorthwell Health·Phase 2·NCT02066311·15 enrolled

Lymphoma1 trial

Dose Escalation Study of Nelfinavir Plus MLN9708 in Patients With Advanced Solid Tumors or Lymphoma

Withdrawn·—·Phase 1·NCT03422874

HIV-1 infection1 trial

Nelfinavir and M8 Drug-level Monitoring in HIV-1 Infection

Completed·UUniversity of Wisconsin, Madison·N/A·NCT00205283·20 enrolled

Solid Tumors1 trial

A Phase I Trial of Nelfinavir (Viracept ) in Adults With Solid Tumors

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT01445106·28 enrolled

Multiple Myeloma1 trial

Nelfinavir and Lenalidomide/Dexamethasone in Progressive Multiple Myeloma

Terminated·SSwiss Cancer Institute·Phase 1/2·NCT01555281·33 enrolled

Unspecified1 trial

Thorough QT Study of Nelfinavir

Completed· Pfizer logo

Pfizer·Phase 4·NCT00312182·68 enrolled

Regulatory

FDA Approval Timeline[4]

Mar 14, 1997

VIRACEPT

NDA NDA020778

Mar 14, 1997

VIRACEPT

NDA NDA020779

Apr 30, 2003

VIRACEPT

NDA NDA021503

Sources

References

[1]
ClinicalTrials.gov — 37 trial records for Nelfinavir. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Nelfinavir compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Nelfinavir. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA021503). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Agouron Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Human Immunodeficiency Virus Type 1 Protease Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: AAgouron Pharmaceuticals

Viracept

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q2 2029

Trials by Indication[1]

Pancreatic Cancer2 trials

Cervical Cancer2 trials

Sepsis1 trial

AIN1 trial

Drug Monitoring1 trial

Children1 trial

Myelofibrosis1 trial

Lipodystrophy1 trial

Rectal Cancer1 trial

Squamous Cell Carcinoma1 trial

Prevention1 trial

Small Cell Lung Cancer1 trial

Locally Advanced1 trial

Cancer of the Head and Neck1 trial

Drug1 trial

HIV infection1 trial

Interaction1 trial

Tics1 trial

Treatment1 trial

Glioblastoma1 trial

Oligometastases1 trial

Non-Small Cell Lung Cancer1 trial

Diarrhea1 trial

Immune System1 trial

Cervical Intraepithelial Neoplasia1 trial

Glioma1 trial

Radiotherapy1 trial

Radiation Therapy1 trial

Myeloma1 trial

Systemic Lupus Erythematosus1 trial

Lymphoma1 trial

HIV-1 infection1 trial

Solid Tumors1 trial

Multiple Myeloma1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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