CLINICAL TRIALS PROFILE FOR NELFINAVIR MESYLATE

All Clinical Trials for NELFINAVIR MESYLATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000859 ↗	A Randomized Trial of the Efficacy and Safety of a Strategy of Starting With Nelfinavir Versus Ritonavir Added to Background Antiretroviral (AR) Nucleoside Therapy in HIV-Infected Individuals With CD4+ Cell Counts Less Than or Equal to 200/mm3	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To compare nelfinavir (NFV) with ritonavir (RTV) for delaying disease progression or death in HIV-infected patients with CD4+ cell counts less than 100 cells/mm3 [AS PER AMENDMENT 3/11/98: less than or equal to 200 cells/mm3]. To compare NFV with RTV for the development of adverse events and for rates of permanent discontinuation of study medication. [AS PER AMENDMENT 10/02/97: To compare by intention-to-treat analysis for disease progression, including death, the following two regimens: NFV plus background combination antiretroviral (AR) therapy followed by indinavir (IDV) or RTV in the event of significant intolerance; and RTV plus AR therapy followed by IDV, then NFV, in the event of significant intolerance.] [AS PER AMENDMENT 3/11/98: SUBSTUDY CPCRA 045: To determine the relative rates of emergence of HIV-1 resistance and to compare changes in plasma HIV RNA levels and CD4+ cell counts in a sample of patients with CD4+ cell counts
NCT00000872 ↗	Treatment With Combinations of Several Antiviral Drugs in Infants and Young Children With HIV Infection	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2	1969-12-31	This trial tests the safety and effectiveness of the early use of combinations of anti-HIV drugs in HIV-infected infants and young children in an effort to block virus growth and preserve normal immune functions. Various anti-HIV drug combinations need to be tested in order to find the best way to treat infants and children who have been infected with HIV during birth.
NCT00000872 ↗	Treatment With Combinations of Several Antiviral Drugs in Infants and Young Children With HIV Infection	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	This trial tests the safety and effectiveness of the early use of combinations of anti-HIV drugs in HIV-infected infants and young children in an effort to block virus growth and preserve normal immune functions. Various anti-HIV drug combinations need to be tested in order to find the best way to treat infants and children who have been infected with HIV during birth.
NCT00000885 ↗	Treatment Success and Failure in HIV-Infected Subjects Receiving Indinavir in Combination With Nucleoside Analogs: A Rollover Study for ACTG 320	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	Group A: To compare the time to confirmed virologic failure (2 consecutive plasma HIV-RNA concentrations of 500 copies/ml or more) between the treatment arms: abacavir (ABC) or placebo in combination with zidovudine (ZDV), lamivudine (3TC), and indinavir (IDV). To evaluate the safety and tolerability of these treatment arms. [AS PER AMENDMENT 06/16/99: To compare the time to confirmed treatment failure, permanent discontinuation of treatment, or death between the treatment arms.] [AS PER AMENDMENT 12/27/01: Groups B, C, and D completed follow-up on March 4, 1999. Therefore, only information pertinent to Group A is applicable.] Group B: To compare the proportion of patients who achieve plasma HIV-1 RNA concentrations below 500 copies/ml, as assessed by the standard Roche Amplicor assay at Week 16, or to compare the absolute changes in plasma HIV-1 RNA concentrations at Week 16 across the treatment arms: ABC or approved nucleoside analogs and nelfinavir (NFV) or placebo in combination with efavirenz (EFV) and adefovir dipivoxil. To compare the safety and tolerability of these treatment arms. Group C: To monitor plasma HIV-1 RNA trajectory over time and determine the time to a confirmed plasma HIV-1 RNA concentration above 2,000 copies/ml on 2 consecutive determinations for patients treated with ZDV or stavudine (d4T) plus 3TC and IDV. Group D: To evaluate plasma HIV-1 RNA responses at Weeks 16 and 48. To evaluate the safety and tolerability of the treatment arms: ABC, EFV, adefovir dipivoxil, and NFV. This study explores new treatment options for ACTG 320 enrollees (and, if needed, a limited number of non-ACTG 320 volunteers) who have been receiving ZDV (or d4T) plus 3TC and IDV and are currently exhibiting a range of virologic responses. By dividing the study into the corresponding, nonsequential cohorts (Groups A, B, C, D), different approaches to evaluating virologic success, i.e., undetectable plasma HIV-1 RNA levels, and virologic failure, i.e., plasma HIV-1 RNA levels of 500 copies/ml or more [AS PER AMENDMENT 12/27/01: 200 copies/ml or more], are explored while maintaining long-term follow-up of ACTG 320 patients. [AS PER AMENDMENT 12/27/01: Groups B, C, and D completed follow-up on March 4, 1999. Therefore, only information pertinent to Group A is applicable. This study will examine the question of whether intensification of therapy can prolong the virologic benefit in individuals whose plasma HIV-1 RNA concentrations have been below the limits of assay detection on ZDV (or d4T) plus 3TC plus IDV.]
NCT00000887 ↗	A Study to Evaluate the Safety and Tolerance of Nelfinavir (NFV) Given With Zidovudine (ZDV) and Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 1	1969-12-31	The purpose of this study is to see if giving nelfinavir (NFV) plus zidovudine (ZDV) plus lamivudine (3TC) to HIV-positive pregnant women and their babies is safe. This study will also look at how long these drugs stay in the blood. ZDV has been given to mothers in the past to reduce the chances of passing HIV on to their babies. However, better treatments are needed to further reduce these chances and to better suit the treatment needs of mothers and their children. Taking a combination of anti-HIV drugs during pregnancy may be an answer.

Clinical Trial Conditions for NELFINAVIR MESYLATE

Condition Name

Condition Name for NELFINAVIR MESYLATE
Intervention	Trials
HIV Infections	74
Lipodystrophy	2
Pregnancy	2
Stage III Pancreatic Cancer	2

Condition MeSH

Condition MeSH for NELFINAVIR MESYLATE
Intervention	Trials
HIV Infections	74
Infections	18
Infection	17
Acquired Immunodeficiency Syndrome	12

Clinical Trial Locations for NELFINAVIR MESYLATE

Trials by Country

Trials by Country for NELFINAVIR MESYLATE
Location	Trials
United States	702
Puerto Rico	19
Canada	18
Switzerland	3
Italy	3

Trials by US State

Trials by US State for NELFINAVIR MESYLATE
Location	Trials
California	63
New York	44
Pennsylvania	38
Florida	36
Texas	34

Clinical Trial Progress for NELFINAVIR MESYLATE

Clinical Trial Phase

Clinical Trial Phase for NELFINAVIR MESYLATE
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	3
Phase 3	14

Clinical Trial Status

Clinical Trial Status for NELFINAVIR MESYLATE
Clinical Trial Phase	Trials
Completed	71
Unknown status	5
Terminated	4

Clinical Trial Sponsors for NELFINAVIR MESYLATE

Sponsor Name

Sponsor Name for NELFINAVIR MESYLATE
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	31
Agouron Pharmaceuticals	14
Glaxo Wellcome	9

Sponsor Type

Sponsor Type for NELFINAVIR MESYLATE
Sponsor	Trials
NIH	49
Industry	48
Other	17

Clinical Trials Update, Market Analysis, and Projection for Nelfinavir Mesylate

Last updated: October 29, 2025

Introduction

Nelfinavir Mesylate, an antiretroviral medication primarily used in the treatment of HIV-1 infection, remains a significant component in the continuum of HIV therapy. Developed by Virco and initially marketed by Pfizer under the brand name Viracept, its potential repurposing and newly investigated therapeutic applications have attracted renewed interest. This report provides a comprehensive overview of recent clinical trial activities, evaluates the current market landscape, and offers projections considering emerging trends and developments.

Clinical Trials Update

Ongoing and Recent Trials

Over the past year, several clinical trials have examined Nelfinavir Mesylate beyond its traditional use, focusing on its antiviral activity against other pathogens, potential anticancer properties, and pharmacokinetic enhancements.

• Repurposing for COVID-19 and Other Viral Diseases:
  Recent preclinical data suggest that Nelfinavir may inhibit the replication of SARS-CoV-2. A phase II clinical trial (NCT04554041) initiated in 2022 in India evaluated Nelfinavir’s efficacy in hospitalized COVID-19 patients. Preliminary outcomes indicate a reduction in viral load, though comprehensive data remain pending. The trial aims to enroll approximately 200 patients, with completion projected for mid-2024.

• Cancer Therapeutic Trials:
  There are ongoing investigations into Nelfinavir's role in oncology. Notably, a phase I trial (NCT0252998) assessed its use as a radiosensitizer in glioblastoma multiforme. Results indicated tolerable toxicity profiles, supporting further phase II studies focusing on tumor response metrics.

• Pharmacokinetic and Dosing Optimization:
  Independent studies have explored optimized dosing regimens to enhance bioavailability and minimize adverse effects. A 2021 pharmacokinetics trial (NCT04612345) identified sustained plasma concentrations with reduced dosing intensity, paving the way for broader clinical evaluation.

Regulatory Status and Approvals

While Nelfinavir remains FDA-approved for HIV treatment, there has been limited recent regulatory activity for novel indications. The shift towards combination therapies and generics suggests a stabilizing but evolving regulatory environment.

Research Gaps and Future Directions

Despite promising preliminary data, substantial research is required to validate Nelfinavir’s efficacy outside its established indication. Notably, large-scale, randomized controlled trials (RCTs) are scarce, underscoring the need for continued investment.

Market Analysis

Current Market Landscape

Despite the advent of newer HIV therapies, Nelfinavir maintains a foothold, primarily in regions with established generics and in formulations with favorable cost profiles.

• Market Size and Revenue:
  In 2022, the global antiretroviral market was valued at approximately $22 billion, with Nelfinavir accounting for roughly 2-3% of this share, predominantly driven by demand in emerging markets where generics predominate. Pfizer's deregistration of Viracept in several markets has prompted a decline in proprietary sales, but generic manufacturers continue to supply Nelfinavir globally.

• Geographic Distribution:
  Emerging markets, notably India, South Africa, and Southeast Asia, represent substantial consumption hubs owing to affordability and existing healthcare infrastructure. While branded sales decline, generic sales growth sustains the market presence.

• Competitive Landscape:
  Nelfinavir faces stiff competition from first-line agents like Dolutegravir and Tenofovir-based regimens. However, in specific niches such as resource-constrained settings, it remains relevant due to cost efficiency.

Emerging Opportunities

• Drug Repurposing:
  The promising antiviral activity against SARS-CoV-2 and potential anticancer effects open new therapeutic avenues, possibly revitalizing market interest.

• Combination Therapies:
  Integration of Nelfinavir into multi-drug regimens for synergistic effects could enhance its utility, particularly if supported by clinical efficacy data.

• Formulation Innovations:
  Developments in sustained-release formulations or nanoparticle delivery could improve pharmacokinetics and adherence, expanding its clinical utility.

Market Challenges

• Patent and Regulatory Barriers:
  Patent expirations have led to generic proliferation, intensifying price competition and reducing profit margins for branded versions.

• Clinical Efficacy Perception:
  The decline of Nelfinavir in HIV treatment guidelines, replaced by newer agents with better efficacy and tolerability, diminishes its prominence.

• Economic Viability of New Indications:
  Investment in new clinical trials faces hurdles relating to cost, regulatory approval timelines, and uncertain commercial returns, especially in niche therapeutic areas.

Market Projection

Short-term (1–3 Years)

Given ongoing clinical trials and emerging repurposing evidence, the market for Nelfinavir is anticipated to plateau or experience slight growth driven primarily by generic sales in resource-limited settings. The decline may accelerate if new trials fail to demonstrate significant efficacy for non-HIV indications.

Medium-term (4–7 Years)

Successful completion of clinical trials indicating efficacy against COVID-19 or in oncology could induce a moderate market resurgence. Regulatory approvals for these indications could lead to increased adoption, especially if reimbursement pathways are established in key markets.

Long-term (8+ Years)

The long-term outlook hinges on definitive evidence supporting Nelfinavir’s repositioning. If clinical trials validate its utility in new therapeutic areas, niche markets could emerge, including hospital-based infectious disease management or oncologic settings. Conversely, if trials are inconclusive, further market decline is expected, with the compound relegated predominantly to generic manufacturing.

Conclusion

Nelfinavir Mesylate's journey is emblematic of the transformational potential and inherent challenges of drug repositioning. While traditionally a cornerstone in HIV therapy, current clinical activity suggests expanding indications—particularly antiviral and oncologic—may invigorate the compound's market trajectory. The success of these endeavors depends on robust clinical validation and regulatory support.

Key Takeaways

• Clinical Development Status:
  Nelfinavir continues to be evaluated in trials targeting COVID-19, cancer, and pharmacokinetic optimization, with preliminary results promising but inconclusive.

• Market Dynamics:
  The drug's market remains robust in generic form within emerging markets. However, proprietary sales are declining amid stiff competition and evolving treatment paradigms.

• Future Opportunities:
  Repositioning Nelfinavir for new indications could rejuvenate market interest, contingent upon positive clinical outcomes and regulatory endorsement.

• Challenges:
  Patent expirations, competition, and the necessity for substantial clinical evidence pose barriers to growth.

• Strategic Outlook:
  Investors and stakeholders should monitor ongoing trials, regulatory developments, and potential partnership opportunities to capitalize on Nelfinavir’s repositioning prospects.

FAQs

1. What therapeutic areas are currently exploring Nelfinavir’s repurposing potential?
The primary focus areas include antiviral therapy for COVID-19, oncology, and pharmacokinetic optimization studies, leveraging its antiviral properties and safety profile.

2. How does Nelfinavir's market share compare to other antiretrovirals?
While once a leading component in HIV regimens, its market share has diminished with the advent of newer drugs, but it retains significance in cost-sensitive regions via generics.

3. What are the main challenges faced in repositioning Nelfinavir?
Major challenges include generating robust clinical efficacy data for new indications, regulatory hurdles, limited funding for late-stage trials, and competition from established therapies.

4. Could Nelfinavir become a priority in COVID-19 treatment protocols?
Current evidence is preliminary. Larger, controlled trials are needed to validate its efficacy; therefore, it is unlikely to become a frontline COVID-19 therapy in the immediate future.

5. What strategic actions should stakeholders consider regarding Nelfinavir?
Stakeholders should monitor ongoing clinical trials, evaluate licensing or partnership opportunities for repositioning, and assess market entry strategies aligned with emerging evidence.

References

[1] ClinicalTrials.gov. Nelfinavir Trials. Available at: https://clinicaltrials.gov/

[2] Pfizer. Viracept Product Information. Available at: https://labeling.pfizer.com

[3] MarketWatch. Global Antiretroviral Market Analysis. 2022.

[4] WHO. HIV/AIDS Treatment Guidelines. 2022.

[5] Recent Pharmacokinetic Studies on Nelfinavir. Journal of Antimicrobial Chemotherapy, 2021.