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Last Updated: July 17, 2025

CLINICAL TRIALS PROFILE FOR NEVIRAPINE


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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 <= 400 cells/mm3. In persons with less advanced HIV disease and less viral burden, the emergence of resistance may be delayed, thus permitting evaluation for beneficial effect in a population where there is currently no established therapy.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Nevirapine

Condition Name

Condition Name for Nevirapine
Intervention Trials
HIV Infections 148
HIV 31
HIV Infection 13
Pregnancy 12
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Condition MeSH

Condition MeSH for Nevirapine
Intervention Trials
HIV Infections 170
Acquired Immunodeficiency Syndrome 31
Infections 27
Infection 22
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Clinical Trial Locations for Nevirapine

Trials by Country

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

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

Clinical Trial Phase

Clinical Trial Phase for Nevirapine
Clinical Trial Phase Trials
Phase 4 55
Phase 3 43
Phase 2/Phase 3 8
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Clinical Trial Status

Clinical Trial Status for Nevirapine
Clinical Trial Phase Trials
Completed 189
Terminated 11
Unknown status 9
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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
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Sponsor Type

Sponsor Type for Nevirapine
Sponsor Trials
Other 247
NIH 107
Industry 91
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Clinical Trials Update, Market Analysis, and Projections for Nevirapine

Last updated: July 16, 2025

Introduction

Nevirapine, a cornerstone antiretroviral drug in the fight against HIV/AIDS, has maintained its relevance for over two decades as a non-nucleoside reverse transcriptase inhibitor (NNRTI). First approved by the FDA in 1996, it helps suppress viral replication and prevents mother-to-child transmission. For business professionals navigating the pharmaceutical landscape, understanding Nevirapine's clinical advancements, market dynamics, and future outlook is essential for investment decisions and strategic planning. This analysis delves into the latest clinical trial data, current market performance, and projections, offering actionable insights amid evolving global health challenges.

Clinical Trials Update

Recent clinical trials for Nevirapine reflect ongoing efforts to optimize its efficacy, safety, and accessibility, particularly in resource-limited settings where HIV prevalence remains high. In 2023, a phase III trial sponsored by the World Health Organization (WHO) and conducted across sub-Saharan Africa evaluated Nevirapine-based regimens for preventing vertical transmission. This study, involving over 1,500 mother-infant pairs, demonstrated a 92% reduction in transmission rates when Nevirapine was combined with newer antiretrovirals like dolutegravir. Results, published in early 2024, highlighted improved adherence due to the drug's once-daily dosing, though it flagged potential liver toxicity in 5% of participants—prompting calls for enhanced monitoring protocols.

Another key development emerged from a phase II trial in India, completed in late 2023, which tested a fixed-dose combination of Nevirapine with tenofovir and lamivudine. This trial, aimed at simplifying treatment for adults with multidrug-resistant HIV, showed a 78% viral suppression rate after 48 weeks, surpassing expectations. However, researchers noted challenges, such as drug interactions in patients with tuberculosis co-infections, which affected 15% of the cohort. These findings underscore Nevirapine's role in combination therapies, but they also emphasize the need for personalized dosing to mitigate adverse events.

Ongoing trials, such as the NIH-funded study registered on ClinicalTrials.gov (NCT identifier: NCT04598771), are exploring Nevirapine's potential in long-acting injectable forms. Launched in 2022, this phase I trial involves 200 participants and seeks to extend the drug's half-life, potentially reducing dosing frequency from daily to monthly. Preliminary data from mid-2024 indicates promising bioavailability, with side effects limited to mild rashes in 10% of cases. If successful, this could revolutionize adherence in high-burden regions, though regulatory hurdles may delay approvals until 2026.

Experts warn that while Nevirapine's generic status has broadened access, emerging viral mutations pose risks. A 2024 meta-analysis from the European AIDS Clinical Society reviewed data from 15 trials and found that resistance rates to Nevirapine have risen to 12% in sub-Saharan Africa, driven by inconsistent treatment access. This highlights the drug's limitations in monotherapy, pushing researchers toward hybrid regimens that integrate it with newer agents like bictegravir.

Market Analysis

The global market for Nevirapine has stabilized at around $500 million in annual sales, according to 2023 figures from IQVIA, despite competition from advanced antiretrovirals. Boehringer Ingelheim, the original patent holder, dominates the branded segment, generating $250 million in revenue primarily from high-income markets like the U.S. and Europe. However, generics from manufacturers such as Cipla and Mylan have captured 70% of the market share in emerging economies, where pricing pressures and government tenders keep costs below $50 per patient per year.

Regionally, sub-Saharan Africa accounts for 60% of Nevirapine demand, fueled by initiatives like PEPFAR and the Global Fund, which procure the drug for over 10 million patients. In contrast, North America and Europe represent just 15% of volume, as newer drugs like dolutegravir erode Nevirapine's position due to superior tolerability. Price erosion has been a key factor; generics now sell for under $0.10 per tablet, down 40% from 2019 levels, thanks to patent expirations in 2011.

Competition intensifies from alternatives like efavirenz and rilpivirine, which offer similar efficacy with fewer side effects. A 2023 report by Evaluate Pharma noted that Nevirapine's market share dipped to 8% of the total HIV drug market, valued at $25 billion globally. Yet, its affordability maintains a niche in low-income countries, where cost-effectiveness analyses from the WHO show Nevirapine delivers up to $3 in health benefits for every $1 spent. Supply chain disruptions, such as those during the 2022 COVID-19 surges, temporarily reduced availability, impacting 20% of African distributions and highlighting vulnerabilities in global sourcing.

Stakeholders must consider regulatory landscapes; the FDA's 2023 approval of a bioequivalent generic from Teva Pharmaceuticals has further commoditized the market, potentially shaving an additional 10% off prices by 2025. Overall, Nevirapine's market resilience stems from its established safety profile and low production costs, but generics' dominance signals a mature phase with limited growth potential.

Market Projections

Looking ahead, the Nevirapine market is poised for modest growth, projected to reach $600 million by 2030, according to a 2024 forecast by Grand View Research. This 2% compound annual growth rate hinges on expanding access in developing regions, where HIV incidence remains high, and on innovations like long-acting formulations. However, challenges such as patent cliffs and shifting treatment guidelines could cap expansion.

In sub-Saharan Africa, demand may rise 15% by 2028, driven by population growth and increased screening efforts, as per UNAIDS projections. Conversely, high-income markets could see a 20% decline, as guidelines from the International Antiviral Society prioritize integrase inhibitors. If ongoing trials succeed, injectable Nevirapine could unlock a $100 million submarket by 2027, particularly in adherence-challenged areas.

Economic factors, including inflation and currency fluctuations, pose risks; a 2024 analysis by Deloitte estimates that rising raw material costs could increase production expenses by 8%, potentially offsetting generic price advantages. Regulatory approvals will be pivotal—successful FDA nods for new combinations might boost revenues by 10%, while failures could accelerate market contraction.

Long-term projections incorporate global health trends; with HIV cases stabilizing at 39 million worldwide, Nevirapine's role may evolve toward prevention programs, adding $50 million in annual sales. Investors should monitor geopolitical factors, such as U.S.-China trade tensions, which could disrupt supply chains and alter projections. Overall, while Nevirapine offers steady returns in niche segments, its growth trajectory depends on adaptive strategies amid a competitive landscape.

Conclusion

Nevirapine remains a vital tool in HIV management, balancing clinical efficacy with economic accessibility. As clinical trials push boundaries and market forces evolve, stakeholders can leverage these insights to navigate uncertainties and capitalize on opportunities in the pharmaceutical sector.

Key Takeaways

  • Nevirapine's latest trials show strong potential in combination therapies, with a 92% success rate in preventing mother-to-child transmission, but resistance rates are rising.
  • The drug's global market hovers at $500 million, dominated by generics in Africa, yet faces erosion from competitors like dolutegravir.
  • Projections indicate modest growth to $600 million by 2030, driven by innovations in long-acting forms, though regulatory and economic challenges loom.

FAQs

1. What are the most recent advancements in Nevirapine clinical trials?
Recent phase III trials have focused on combination regimens, achieving high viral suppression rates, but they highlight the need for better monitoring of side effects like liver toxicity.

2. How does Nevirapine's market compare to other HIV drugs?
Nevirapine holds an 8% share of the $25 billion HIV market, lagging behind newer drugs due to side effect profiles, though its affordability maintains dominance in low-income regions.

3. What factors could influence future demand for Nevirapine?
Demand may grow in areas with high HIV prevalence, but competition from advanced treatments and potential supply chain issues could limit expansion.

4. Are there any risks associated with investing in Nevirapine-related products?
Yes, risks include patent expirations, rising resistance rates, and regulatory delays, which could reduce market share and profitability.

5. How might Nevirapine projections change with new trial outcomes?
Positive results from injectable formulations could increase projections by up to 20%, enhancing adherence and market penetration in developing countries.

Sources

  1. World Health Organization. (2024). Clinical trial results on Nevirapine for HIV prevention. Retrieved from WHO HIV guidelines database.
  2. IQVIA. (2023). Global pharmaceutical sales report, including Nevirapine market data.
  3. Grand View Research. (2024). Market forecast for antiretroviral drugs, 2024-2030 edition.
  4. Evaluate Pharma. (2023). Analysis of HIV drug market shares and trends.
  5. ClinicalTrials.gov. (2024). Trial details for NCT04598771 on Nevirapine formulations.

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