CLINICAL TRIALS PROFILE FOR DELAVIRDINE MESYLATE

All Clinical Trials for delavirdine mesylate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000803 ↗	A Phase II Double-Blind Study of Delavirdine Mesylate ( U-90152 ) in Combination With Zidovudine ( AZT ) and/or Didanosine ( ddI ) Versus AZT and ddI Combination Therapy	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To determine the safety and anti-HIV activity of delavirdine mesylate ( U-90152 ) in combination with zidovudine ( AZT ) and/or didanosine ( ddI ) versus AZT/ddI combination. U-90152 has demonstrated anti-HIV activity. Since the combination of this drug with either AZT or ddI has synergistic inhibitory activity against HIV-1 in vitro, and triple therapy appears to have greater inhibitory activity against HIV-1 in vitro than dual therapy, the use of U-90152 in combination with AZT and/or ddI may improve the benefits of these drugs in persons with HIV disease.
NCT00000810 ↗	Randomized, Phase I/II, Dose-Ranging, Open-Label Trial of the Anti-HIV Activity of Delavirdine Mesylate (DLV; U-90,152S)	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	PRIMARY: To study the safety and tolerance of delavirdine mesylate ( U-90152 ) monotherapy. To compare the anti-HIV activity of three blood concentration levels of this agent with nucleoside analog monotherapy, either zidovudine ( AZT ) or didanosine ( ddI ), based on the reduction of HIV viral burden. SECONDARY: To use pharmacokinetic parameters to assess the relationship between daily drug exposure and antiviral activity and toxicity of the U-90152, AZT, and ddI monotherapy. To assess anti-HIV activity using other disease markers. Data suggest that bisheteroarylpiperazines (BHAPs) such as delavirdine mesylate are potent and safe anti-HIV agents and may have different biological behavior than other currently available non-nucleoside RT inhibitors.
NCT00000882 ↗	Virologic and Immunologic Activity of Continued Lamivudine (3TC) vs Delavirdine (DLV) in Combination With Indinavir (IDV) and Zidovudine (ZDV) or Stavudine (d4T) in 3TC-Experienced Subjects	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To compare the proportion of patients in the 2 zidovudine (ZDV)-containing arms who have a plasma HIV RNA concentration below the limit of detection (defined as 500 copies/ml or less) at Weeks 20 and 24 [AS PER AMENDMENT 8/24/98: HIV RNA concentration below the limit of detection is now defined as 200 copies/ml or less]. To compare the safety and tolerability of the different treatment regimens. To compare the decrease in plasma HIV-1 RNA and the change in CD4 count from baseline to the average of Weeks 20 and 24 [AS PER AMENDMENT 12/19/97: and to the average of Weeks 44 and 48; AS PER AMENDMENT 8/24/98: and the average of Weeks 88 and 96] in the 2 ZDV-containing arms. To study the emergence of resistance to ZDV, lamivudine (3TC), stavudine (d4T), delavirdine (DLV), and indinavir (IDV) in treated patients. To correlate the antiviral and immunologic activity and emergence of drug resistance with pharmacologic parameters of study drugs. To delineate the pharmacokinetic interactions of IDV and DLV. [AS PER AMENDMENT 12/19/97: To delineate the possible development of cellular resistance to nucleoside analogs and the consequences of switching nucleoside study drugs on intracellular phosphorylation.] To document rates and patterns of adherence over the course of the study, from day of randomization through 48 weeks. [AS PER AMENDMENT 8/24/98: To define long-term durability of the virologic activity of the different treatment regimens, as defined by the proportion of patients with plasma HIV-1 RNA levels that remains below the limit of detection. To define long-term tolerability of the different treatment regimens.] Although a change in reverse transcriptase (RT) inhibitors is recommended when adding or changing protease inhibitors in a treatment regimen, the choice of available RT inhibitors is often limited by prior exposure, toxicity, or pharmacologic interaction with the protease inhibitors. This study addresses the question of whether to continue 3TC or substitute the nonnucleoside reverse transcriptase inhibitor (NNRTI) DLV when adding IDV to therapy for patients previously treated with ddI or d4T plus 3TC who have greater than 500 copies/ml of plasma HIV-1 RNA. Although the activity of DLV as monotherapy or in combination with nucleoside reverse transcriptase inhibitors is of limited duration due to rapid emergence of resistance, it is possible that DLV will contribute significantly to the activity of 3-drug regimens that include a new RT inhibitor plus a protease inhibitor.
NCT00000891 ↗	Immunologic and Virologic Consequences of Long-Term Highly Active Antiretroviral Therapy (HAART) in Subjects With Moderately Advanced HIV-1 Disease: A Follow-Up Study to ACTG 315	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To evaluate the relationship between viral suppression and changes in immune function, as measured by the restoration of delayed-type hypersensitivity (DTH) and lymphoproliferative (LP) responses, observed after 48 weeks of treatment with highly active antiretroviral therapy (HAART) in ACTG 315. To evaluate the durability of the antiviral and immunologic effects of long-term treatment with HAART. Given the extensive immunologic and virologic data available from ACTG 315, follow-up studies of this advanced-disease population are indicated to primarily ascertain the impact of long-term suppression of viral replication on immunologic reconstitution or re-education and the durability of the antiviral effects of HAART.
NCT00000892 ↗	A Study of Several Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Used Indinavir	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To compare the proportion of patients whose plasma HIV-1 RNA is below 500 copies/ml after 16 weeks of treatment. To assess the safety, toxicity, and tolerance of each treatment arm. While indinavir is currently the most commonly prescribed protease inhibitor, the optimal therapy for a person on an indinavir-containing regimen who experiences a rebound in viral load or never experiences a decrease in viral load below 500 copies per milliliter is unknown. Current clinical practice for such patients typically involves empiric use of a combination of other protease inhibitors (saquinavir/nelfinavir or saquinavir/ritonavir) and at least 1 other antiretroviral agent to which the patient has had little or no prior exposure. This may involve the use of 1 or more reverse transcriptase inhibitors (RTIs) or nonnucleoside reverse transcriptase inhibitors (NNRTIs). This study attempts to formally evaluate some of these options in indinavir-experienced patients.

Clinical Trial Conditions for delavirdine mesylate

Condition Name

Condition Name for delavirdine mesylate
Intervention	Trials
HIV Infections	18

Condition MeSH

Condition MeSH for delavirdine mesylate
Intervention	Trials
HIV Infections	18
Acquired Immunodeficiency Syndrome	1
Infections	1
Infection	1

Clinical Trial Locations for delavirdine mesylate

Trials by Country

Trials by Country for delavirdine mesylate
Location	Trials
United States	183
Puerto Rico	6
Spain	1
Italy	1
Germany	1

Trials by US State

Trials by US State for delavirdine mesylate
Location	Trials
California	12
Colorado	9
Ohio	9
New York	9
Florida	8

Clinical Trial Progress for delavirdine mesylate

Clinical Trial Phase

Clinical Trial Phase for delavirdine mesylate
Clinical Trial Phase	Trials
Phase 3	4
Phase 2	6
Phase 1	1

Clinical Trial Status

Clinical Trial Status for delavirdine mesylate
Clinical Trial Phase	Trials
Completed	15
Terminated	2
Withdrawn	1

Clinical Trial Sponsors for delavirdine mesylate

Sponsor Name

Sponsor Name for delavirdine mesylate
Sponsor	Trials
Pharmacia and Upjohn	9
National Institute of Allergy and Infectious Diseases (NIAID)	6
Hoffmann-La Roche	2

Sponsor Type

Sponsor Type for delavirdine mesylate
Sponsor	Trials
Industry	14
NIH	6

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

Last updated: October 28, 2025

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Introduction

Delavirdine mesylate is a non-nucleoside reverse transcriptase inhibitor (NNRTI), developed primarily for HIV-1 treatment. Approved initially in the early 2000s, its role within antiretroviral therapy (ART) has shifted due to evolving treatment paradigms and the emergence of newer agents. This report evaluates the current clinical trial landscape, analyzes market dynamics, and projects the future trajectory of delavirdine mesylate within the antiviral sector.

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Clinical Trials Update

Current Clinical Trial Landscape

As of the latest data, delavirdine mesylate exhibits limited ongoing clinical investigations compared to other NNRTIs. The majority of active studies focus on drug repositioning, biosimilar development, or combination therapy evaluations rather than standalone efficacy assessments.

• Registered Trials: According to ClinicalTrials.gov, there are no recent or ongoing trials evaluating delavirdine mesylate as monotherapy or in combination regimens. Previous studies have largely been completed, assessing its pharmacokinetics, safety, and efficacy in early-phase and Phase III trials during the early 2000s.

• Adverse Events and Safety Profile: Early trials highlighted concerns about adverse effects, including hepatotoxicity and drug interactions, which contributed to the drug's declining use. No recent trials indicate renewed interest based on safety or efficacy improvements.

• Regulatory Status: Delavirdine mesylate’s approval in the United States (by the FDA) was granted in 1997 and later withdrawn for commercial reasons. The absence of current trials suggests its market presence is limited, primarily historical.

Research Trends and Innovations

Given the advent of integrase inhibitors (e.g., dolutegravir, bictegravir) and longer-acting formulations, the scientific community’s focus has shifted away from older NNRTIs like delavirdine. The drug's pharmacokinetic limitations, including limited blood-brain barrier penetration and interaction profiles, diminish its attractiveness for novel clinical applications.

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Market Analysis

Historical Market Position

During its initial launch, delavirdine mesylate occupied a niche in the HIV therapeutic landscape, alongside drugs like efavirenz and nevirapine. However, its market share rapidly declined due to:

• Adverse Effect Profile: Higher rates of hepatotoxicity.
• Drug Interactions: Significant CYP450 enzyme interactions.
• Efficacy Limitations: Comparatively less potent than newer agents with improved pharmacokinetics.

Current Market Dynamics

• Market Size & Revenue: The global HIV therapeutics market was valued at approximately US$25 billion in 2022, with NNRTIs constituting a declining segment owing to the emergence of integrase strand transfer inhibitors (INSTIs). Delavirdine mesylate, due to market withdrawal and limited availability, contributes marginally to current sales.

• Competitive Landscape: Dominated by drugs like bictegravir, dolutegravir, and cabotegravir, which offer better tolerability, longer dosing intervals, and fewer drug interactions.

• Regulatory & Patent Status: The original patents have expired, and the drug is largely absent from current formulations. Licensing or new formulations are unlikely given the availability of superior alternatives.

• Generic & Biosimilar Prospects: Minimal, given the drug’s limited commercial presence and obsolete status.

Pharmacoeconomic Factors

The shift towards injectable and long-acting oral agents reduces demand for older oral NNRTIs like delavirdine. Additionally, the high cost of adverse event management and drug interactions further diminishes its market viability.

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Market Projection

Short-term Outlook (Next 5 Years)

• Revival unlikely: Given the current scientific priorities and market trends, delavirdine mesylate is unlikely to experience a resurgence.
• Niche opportunities: Findings from exploratory research in niche viral populations or co-infection contexts are theoretically possible but improbable without significant innovation.

Long-term Outlook (Beyond 5 Years)

• Obsolescence: The drug is expected to remain on the periphery of the HIV treatment market, primarily as a historical reference or in legacy treatment settings.
• Potential repurposing: Unlikely, due to safety profile limitations and lack of ongoing research.

Innovative Perspectives

Any future revival would depend on novel delivery platforms, toxicity mitigation, or targeted indications where existing agents falter. Currently, no strategic or technological developments are aligned with such outcomes.

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Key Market Drivers and Barriers

Drivers	Barriers
Continued demand for effective antiretroviral agents	Superior efficacy and safety profiles of newer drugs
Patent expiration enabling generic production	High adverse effect and interaction risks
Advancements in combination therapy formulations	Declining clinical relevance
Increased focus on long-acting injectable ART	Limited scientific foundation for reinvestment

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Strategic Recommendations

• For Pharmaceutical Companies: Focus on novel NNRTIs or combination regimens rather than delavirdine mesylate.
• For Research Institutions: Limited scope exists; consider redirected research toward newer agents.
• For Investors: The asset’s market potential is minimal; divert resources toward innovative antiretrovirals.

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Conclusion

Delavirdine mesylate, once a pivotal HIV therapy, has seen its clinical and commercial importance wane significantly. The absence of ongoing clinical trials and minimal market share reflect its obsolescence in the current antiretroviral landscape. Its future prospects remain confined to historical and niche contexts unless transformative innovations emerge.

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Key Takeaways

• Clinical activity has ceased: No recent trials suggest renewed interest.
• Market presence is negligible: Dominated by newer, safer, and more effective ART options.
• Obsolescence is imminent: Persistent safety issues and competition render delavirdine mesylate unviable in modern HIV therapy.
• Investment in newer therapies is preferred: Resources should align with innovative agents offering improved patient outcomes.
• Potential niche uses are unlikely: Without significant technological advances, delavirdine's role remains historical.

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FAQs

1. Why was delavirdine mesylate withdrawn from the market?
Its withdrawal was driven by safety concerns, adverse interactions, and competition from more effective NNRTIs like efavirenz and newer classes such as integrase inhibitors.

2. Are there ongoing clinical trials evaluating delavirdine mesylate?
No, there are no current clinical studies focusing on delavirdine mesylate, reflecting its obsolescence in contemporary HIV treatment.

3. Can delavirdine mesylate be repurposed for other indications?
Currently, no evidence supports repurposing; safety issues and outdated pharmacologic profiles limit its potential.

4. How does delavirdine compare with newer NNRTIs?
It offers inferior safety, efficacy, and pharmacokinetics compared to drugs like doravirine or efavirenz, which have better tolerance and dosing convenience.

5. What is the future outlook for drugs like delavirdine?
Their future is primarily historical; emphasis is now on long-acting formulations and agents with improved safety and efficacy profiles.

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References

1. ClinicalTrials.gov: Listing of clinical trials involving delavirdine mesylate.
2. FDA Drug Approval Records: Details on the approval and withdrawal of delavirdine.
3. Market Reports: Data on the global HIV therapeutics market and market share analyses.
4. Scientific Literature: Studies on the pharmacokinetics and adverse effects of delavirdine.
5. Industry Analysis: Reports on the evolution of antiretroviral therapies and future trends.

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This comprehensive overview offers critical insights for pharmaceutical developers, investors, and healthcare strategists seeking an informed perspective on delavirdine mesylate’s clinical, commercial, and strategic positioning.