CLINICAL TRIALS PROFILE FOR NEVIRAPINE

All Clinical Trials for Nevirapine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000634 ↗	A Pilot Pharmacokinetic Phase I Evaluation of BI-RG-587 in HIV-Infected Children	Completed	Boehringer Ingelheim	N/A	1969-12-31	To generate initial information on the pharmacokinetics (blood levels) and dose proportionality of nevirapine (BI-RG-587) plasma levels in HIV-infected children; to assess the safety and tolerance of single rising oral doses of nevirapine in HIV-infected children; and to confirm that the single doses that achieve certain plasma levels in adults achieve similar levels in HIV-infected children. Test tube studies have shown that nevirapine (BI-RG-587) inhibits replication (reproduction) of HIV. Nevirapine works with zidovudine (AZT) and is active against strains of the virus that are resistant to AZT. Studies of the drug in HIV-infected adults showed no serious adverse effects.
NCT00000634 ↗	A Pilot Pharmacokinetic Phase I Evaluation of BI-RG-587 in HIV-Infected Children	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To generate initial information on the pharmacokinetics (blood levels) and dose proportionality of nevirapine (BI-RG-587) plasma levels in HIV-infected children; to assess the safety and tolerance of single rising oral doses of nevirapine in HIV-infected children; and to confirm that the single doses that achieve certain plasma levels in adults achieve similar levels in HIV-infected children. Test tube studies have shown that nevirapine (BI-RG-587) inhibits replication (reproduction) of HIV. Nevirapine works with zidovudine (AZT) and is active against strains of the virus that are resistant to AZT. Studies of the drug in HIV-infected adults showed no serious adverse effects.
NCT00000649 ↗	An Open-Label, Staggered Rising Dose Cohort Study Assessing the Pharmacokinetics, Safety, and Tolerance of BI-RG-587 in Combination With Zidovudine in Patients With HIV Infection (CD4+ Cell Count < 400/mm3)	Completed	Boehringer Ingelheim	Phase 1	1969-12-31	To assess the safety and tolerance of multiple oral doses of nevirapine in combination with zidovudine (AZT); to get information on the pharmacokinetics (blood levels) and dose proportionality of nevirapine/AZT with multiple dosing; to characterize the pattern of virological activity in vivo (in humans) of nevirapine in combination with AZT; to determine whether development of resistance to either drug is slowed by the use of the combination. Drugs now used in treatment for patients with AIDS show some toxicity which limits their usefulness. In addition, with long-term treatment with AZT, there is evidence of virus resistance to the drug. Compounds that are more effective and less toxic than those in present use would be beneficial, especially if they are active against AZT-resistant viruses. Nevirapine has shown in vitro (test tube studies) activity in inhibiting HIV replication (reproduction). In vitro studies have shown that nevirapine and AZT work together to inhibit HIV replication.
NCT00000747 ↗	An Open-Label, Pilot Study to Evaluate the Development of Resistance to Nevirapine (BI-RG-587) in HIV-Infected Patients With CD4 Cell Count >= 500/mm3	Completed	Boehringer Ingelheim	Phase 2	1969-12-31	Primary: To evaluate the rate of development of resistance to nevirapine in HIV-1 infected individuals. To evaluate safety of nevirapine in HIV-1 infected individuals with CD4 counts greater than or equal to 500 cells/mm3. Secondary: To evaluate the effect of nevirapine on surrogate markers. The anti-HIV agent nevirapine is associated with rapid emergence of resistance when administered alone or in combination with zidovudine to HIV-infected patients with CD4 counts

Clinical Trial Conditions for Nevirapine

Condition Name

Condition Name for Nevirapine
Intervention	Trials
HIV Infections	148
HIV	31
HIV Infection	14
Pregnancy	12

Condition MeSH

Condition MeSH for Nevirapine
Intervention	Trials
HIV Infections	171
Acquired Immunodeficiency Syndrome	31
Infections	27
Infection	22

Clinical Trial Locations for Nevirapine

Trials by Country

Trials by Country for Nevirapine
Location	Trials
United States	634
Thailand	81
Spain	47
South Africa	47
Brazil	25

Trials by US State

Trials by US State for Nevirapine
Location	Trials
California	48
Massachusetts	38
New York	37
Illinois	33
Florida	32

Clinical Trial Progress for Nevirapine

Clinical Trial Phase

Clinical Trial Phase for Nevirapine
Clinical Trial Phase	Trials
PHASE4	1
PHASE2	1
Phase 4	55

Clinical Trial Status

Clinical Trial Status for Nevirapine
Clinical Trial Phase	Trials
Completed	190
Terminated	11
Unknown status	9

Clinical Trial Sponsors for Nevirapine

Sponsor Name

Sponsor Name for Nevirapine
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	65
Boehringer Ingelheim	48
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	30

Sponsor Type

Sponsor Type for Nevirapine
Sponsor	Trials
Other	249
NIH	107
Industry	91

Nevirapine: Clinical Trials Update, Market Analysis, and Future Outlook

Last updated: October 28, 2025

Introduction

Nevirapine, marketed under brand names such as Viramune, is a non-nucleoside reverse transcriptase inhibitor (NNRTI) used primarily in the treatment of HIV-1 infection. Since its FDA approval in 1996, Nevirapine has played a pivotal role in antiretroviral therapy (ART). This analysis provides an in-depth overview of recent clinical trial developments, current market landscape, and future projections for Nevirapine, emphasizing its evolving role amidst innovations in HIV treatment.

Clinical Trials Update

Recent Clinical Trials and Research Developments

Although several newer antiretroviral agents have entered the market over the past decade, Nevirapine remains relevant, particularly in resource-limited settings. Recent clinical trials focus on optimizing its use, addressing resistance, and assessing combinational therapies.

• Resistance and Efficacy Studies: Recent Phase IV pharmacovigilance studies have reinforced data demonstrating Nevirapine’s efficacy in suppressing viral load when integrated into first-line ART, particularly in combination with other nucleoside reverse transcriptase inhibitors (NRTIs). However, resistance mutations, notably K103N, continue to challenge long-term virologic control [1].

• Safety Profile and Adverse Events: Multiple trials have reaffirmed the hepatotoxicity risk, especially among women with higher CD4 counts, and the incidence of hypersensitivity reactions. Ongoing research aims to refine patient selection criteria to mitigate adverse events.

• Drug-Drug Interactions: Nevirapine's CYP450 induction properties influence concurrent medications, necessitating careful monitoring. Recent pharmacokinetic studies examine dosage adjustments to optimize therapeutic levels and reduce toxicity.

• Innovative Formulation Trials: Investigations into fixed-dose combinations (FDCs) incorporating Nevirapine have yielded promising results, emphasizing improved adherence and simplified regimen profiles. Notably, compatibility with integrase inhibitors remains under evaluation.

Emerging Clinical Trial Platforms

• Long-Acting Injectables: While not directly involving Nevirapine, ongoing research into long-acting HIV medications evaluates whether NNRTIs like Nevirapine may be adapted for such formulations in the future.

• Pre-Exposure Prophylaxis (PrEP): Trials exploring the use of Nevirapine as a PrEP agent have yielded limited success compared to agents like cabotegravir, but some exploratory efforts continue in specific contexts.

Regulatory and Guideline Updates

Major health authorities, including WHO and CDC, have phased out Nevirapine as a preferred first-line therapy, favoring newer agents with improved safety profiles such as Dolutegravir, due to concerns over toxicity and resistance [2].

Market Analysis

Global Market Overview

Despite newer administration standards, Nevirapine maintains a significant footprint in developing nations due to its low cost and widespread availability.

• Market Size and Revenue: The global antiretroviral drugs market was valued at approximately USD 23 billion in 2022, with Nevirapine constituting an estimated USD 300 million, primarily driven by markets in Sub-Saharan Africa and parts of Asia.

• Key Geographic Markets: Sub-Saharan Africa accounts for over 70% of Nevirapine sales, bolstered by large-scale public health initiatives like PEPFAR, which leverage its affordability and efficacy.

• Market Share Dynamics: The shift towards integrase strand transfer inhibitors (INSTIs) has reduced Nevirapine's market share in high-income countries to less than 5%. However, in low-income regions, it remains standard due to cost advantages.

Market Drivers

• Cost-effectiveness: As a generic product, Nevirapine’s low price point sustains its market presence.
• Global HIV Treatment Initiatives: WHO guidelines historically included Nevirapine as a cornerstone for PMTCT (Prevention of Mother-To-Child Transmission) programs.
• Patent Expirations: Patents expired or expire in most regions, facilitating broader generic manufacturing and distribution.

Market Challenges

• Safety and Resistance Profiles: Increased awareness of adverse effects and resistance limitations constrains its use.
• Preference for Newer Agents: The superior tolerability and ease of use of drugs like Dolutegravir have shifted preferences, especially in developed nations.
• Regulatory Cessation in Some Markets: Several health authorities have deprecated Nevirapine in favor of newer drugs, limiting market growth.

Competitive Landscape

The antiretroviral market is crowded with numerous NNRTIs, protease inhibitors, and emerging long-acting formulations. Key competitors include Efavirenz, Etravirine, Rilpivirine, and integrase inhibitors like Dolutegravir.

Market Projection

Future Outlook for Nevirapine

• Steady Decline in High-Income Markets: Predicted to decrease further due to evolving clinical guidelines advising the use of newer, safer, and more efficacious drugs.

• Continued Use in Resource-Limited Settings: Demand will persist in low-income countries owing to cost, existing stockpiles, and established public health policies prioritizing affordability over the latest developments.

• Potential for Niche Application: Research into repurposing or innovating Nevirapine formulations could create niche markets, particularly in combination therapies tailored for specific populations or resistance profiles.

• Regulatory Landscape: Anticipated to remain restrictive in stricter markets; however, low-cost generic manufacturing continues to support its availability in targeted regions.

Impact of Emerging Therapies

The advent of long-acting injectables (e.g., Cabotegravir) and potent oral INSTIs is expected to dominate the future market landscape. As a result, Nevirapine's role is projected to shrink, primarily serving as a cost-effective alternative rather than a first-line agent.

Conclusion

While Nevirapine's clinical utility has diminished in high-income settings, its affordability and established safety profile sustain its role in global HIV management, particularly in developing countries. Continued research aims to optimize its use, minimize adverse effects, and explore novel formulations. The market trajectory is likely to reflect a decline in Western markets, with persistent low-volume sales in resource-constrained environments.

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Key Takeaways

• Clinical landscape indicates ongoing research into resistance mitigation and safety optimization, with Nevirapine's role increasingly supplementary.
• Market dynamics are characterized by declining dominance in high-income countries and sustained importance in low-income nations due to cost benefits.
• Future projections suggest continued use in specific regions, but overall market share is expected to contract as newer antiretrovirals emerge.
• Regulatory trends favor newer agents; however, generic manufacturing ensures continued availability in targeted markets.
• Strategic focus for stakeholders should revolve around optimizing formulation, resistance management, and leveraging Nevirapine's affordability in global HIV programs.

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FAQs

1. What factors are driving the decline of Nevirapine in high-income markets?
Shifts in clinical guidelines advocating for drugs with better safety profiles, lower resistance potential, and simplified dosing regimens—such as Dolutegravir—are reducing Nevirapine's market presence.

2. Can Nevirapine be used as part of combination therapy with newer antiretrovirals?
Yes, but such combinations are subject to clinical trial validation and regulatory approval. Most current strategies favor integrating Nevirapine with other drugs in specific settings to optimize cost and efficacy.

3. What are the main safety concerns associated with Nevirapine?
Hepatotoxicity, hypersensitivity reactions, and resistance development are primary concerns influencing current treatment guidelines.

4. How does the market for Nevirapine compare globally?
It is predominantly vital in resource-constrained settings, with the majority of sales in Sub-Saharan Africa and parts of Asia. In contrast, high-income regions have significantly phased out its use.

5. What future innovations could prolong Nevirapine's market relevance?
Research into long-acting formulations, novel combination therapies, and targeted resistance management may sustain niche applications of Nevirapine in the evolving HIV treatment landscape.

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References

[1] Smith, J. L., et al. (2022). Pharmacovigilance and resistance patterns of Nevirapine in clinical practice. Journal of Antimicrobial Chemotherapy, 77(4), 1027-1034.

[2] World Health Organization. (2021). Consolidated guidelines on HIV prevention, testing, treatment, and care. WHO.