CLINICAL TRIALS PROFILE FOR SUSTIVA

505(b)(2) Clinical Trials for Sustiva

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT00002234 ↗	Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients	Completed	Bristol-Myers Squibb	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.
New Combination	NCT00002234 ↗	Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients	Completed	Dupont Applied Biosciences	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.
New Combination	NCT00002234 ↗	Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients	Completed	Glaxo Wellcome	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.
New Combination	NCT00002234 ↗	Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients	Completed	Gilead Sciences	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.

All Clinical Trials for Sustiva

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001758 ↗	Continued Antiretroviral Therapy With Abacavir, Amprenavir and Efavirenz	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1997-11-01	This study will continue to treat and collect safety and efficacy data on patients who participated in Glaxo-Wellcome's multi-center study on combination therapy with abacavir, amprenavir and efavirenz (A Phase II Study Evaluating the Safety and Antiviral Activity of Combination Therapy with 1592U89, 141W94 and DMP 266 (Sustiva) in HIV-1 Infected Subjects with Detectable [greater than 400 Copies/mL] HIV-1 Plasma RNA Despite Treatment with a Protease Inhibitor-Containing Regimen). HIV-infected patients 18 years of age and older who participated in the above study at the NIH site may be eligible for the current study. Participants will be followed every 3 months with a general health evaluation and laboratory tests. This is a NIH study, and information will not be provided to Glaxo Wellcome
NCT00002234 ↗	Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients	Completed	Bristol-Myers Squibb	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.
NCT00002234 ↗	Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients	Completed	Dupont Applied Biosciences	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.
NCT00002234 ↗	Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients	Completed	Glaxo Wellcome	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.
NCT00002234 ↗	Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients	Completed	Gilead Sciences	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.
NCT00002235 ↗	A Study on the Safety and Effectiveness of Twice-Daily Nelfinavir Plus Twice-Daily Indinavir Plus Efavirenz in HIV-Positive Patients Who Have Never Taken Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) or Protease Inhibitors	Completed	Agouron Pharmaceuticals	Phase 2	1969-12-31	Indinavir is usually taken three times a day. The purpose of this study is to see if it is safe and effective to take indinavir only twice a day plus nelfinavir (also taken twice a day) and efavirenz (taken once a day).
NCT00002235 ↗	A Study on the Safety and Effectiveness of Twice-Daily Nelfinavir Plus Twice-Daily Indinavir Plus Efavirenz in HIV-Positive Patients Who Have Never Taken Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) or Protease Inhibitors	Completed	Merck Sharp & Dohme Corp.	Phase 2	1969-12-31	Indinavir is usually taken three times a day. The purpose of this study is to see if it is safe and effective to take indinavir only twice a day plus nelfinavir (also taken twice a day) and efavirenz (taken once a day).

Clinical Trial Conditions for Sustiva

Condition Name

Condition Name for Sustiva
Intervention	Trials
HIV Infections	36
HIV	11
HIV Infection	8
Healthy	5

Condition MeSH

Condition MeSH for Sustiva
Intervention	Trials
HIV Infections	47
Infections	9
Acquired Immunodeficiency Syndrome	9
Infection	8

Clinical Trial Locations for Sustiva

Trials by Country

Trials by Country for Sustiva
Location	Trials
United States	145
Spain	29
Canada	8
Puerto Rico	6
Brazil	6

Trials by US State

Trials by US State for Sustiva
Location	Trials
California	18
New York	11
District of Columbia	10
Texas	9
Florida	8

Clinical Trial Progress for Sustiva

Clinical Trial Phase

Clinical Trial Phase for Sustiva
Clinical Trial Phase	Trials
Phase 4	19
Phase 3	7
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Sustiva
Clinical Trial Phase	Trials
Completed	55
Unknown status	4
Terminated	3

Clinical Trial Sponsors for Sustiva

Sponsor Name

Sponsor Name for Sustiva
Sponsor	Trials
Bristol-Myers Squibb	8
National Institute of Allergy and Infectious Diseases (NIAID)	6
Abbott	5

Sponsor Type

Sponsor Type for Sustiva
Sponsor	Trials
Other	76
Industry	44
NIH	15

Clinical Trials Update, Market Analysis, and Projection for Sustiva (Efavirenz)

Last updated: January 25, 2026

Executive Summary

Sustiva (efavirenz) remains a cornerstone in antiretroviral therapy (ART) for HIV-1 infection, with ongoing clinical studies exploring expanded indications and optimized formulations. Despite increased competition from integrase inhibitors and novel agents, efavirenz maintains a significant market presence due to its established efficacy, once-daily dosing, and longstanding safety profile. The global efavirenz market was valued at approximately USD 2.3 billion in 2022 and is projected to grow modestly at a CAGR of approximately 2.5% through 2030, driven by expanding HIV treatment programs and emerging generics. Recent clinical developments aim to improve tolerability and adherence, potentially impacting future market dynamics.

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Clinical Trials Update for Sustiva (Efavirenz)

Ongoing Clinical Trials

Trial ID	Title	Phase	Focus	Status	Estimated Completion	Key Objectives
NCT04559225	Efficacy and Safety Study of EFV-based Regimens	Phase IV	Long-term safety and tolerability	Active, not recruiting	Q4 2024	Evaluate long-term safety in diverse populations
NCT04802369	Efavirenz in combination with New Formulations	Phase II	Formulation improvements	Recruiting	Q2 2025	Assess bioavailability and tolerability of new formulations
NCT04195355	Efavirenz as Part of PrEP Candidate	Phase II	Expanded prophylactic use	Completed	2020	Data supports limited off-label investigational use

Recent Data and Publications

• Pharmacokinetics and Tolerability: Recent studies published in The Journal of Acquired Immune Deficiency Syndromes indicate that efavirenz’s pharmacokinetic profile remains stable across populations, with minor variations in sub-Saharan African cohorts.

• Safety Profile: Long-term data (up to 10 years) reaffirm efavirenz’s efficacy but note neuropsychiatric adverse events as a residual concern, leading to increased interest in alternative agents.

Regulatory Updates

• FDA and EMA: Both agencies continue to approve efavirenz-containing fixed-dose combinations, including Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate), with post-marketing surveillance emphasizing safety.

• Labeling Revisions: In 2021, labeling updates highlighted neuropsychiatric adverse event risks, reinforcing contraindications in patients with pre-existing psychiatric conditions.

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Market Analysis for Sustiva (Efavirenz)

Market Size and Segment Breakdown

Region	2022 Market Value (USD billions)	CAGR (2023-2030)	Drivers	Challenges
North America	0.9	2.0%	Established treatment protocols, high HIV prevalence	Competition from integrase inhibitors, safety concerns
Europe	0.5	2.3%	Mature market, increasing generic penetration	Tolerability issues
Asia-Pacific	0.6	3.4%	Growing access, high HIV burden	Limited healthcare infrastructure, regulatory hurdles
Africa	0.2	4.0%	Largest HIV-positive population, generics	Cost sensitivity, supply chain issues

Total Market (2022): USD 2.2 – 2.3 billion

Key Market Players

Company	Market Share (Estimated)	Product Portfolio	Strategic Focus
Mylan (Viatris)	~35%	Generic efavirenz	Expanding regional access
Cipla	~20%	Efavirenz-based formulations	Dose optimization
GSK	<10%	Brand and generics	New formulations, fixed-dose combos
Others	~35%	Multiple regional players	Cost-effective production

Market Dynamics

• Generics Penetration: Over 70% of efavirenz prescriptions are now generic, impacting brand sales.
• Patent Expiry: The patent for Sustiva expired in 2018 in several jurisdictions, catalyzing generic competition.
• Pricing Trends: Prices have decreased by ~40-50% globally over the past five years, with further reductions anticipated as manufacturing costs decline.

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Market Projections (2023–2030)

Year	Estimated Market Value (USD billion)	Annual Growth Rate	Major Growth Drivers	Potential Risks
2023	2.15	—	Continued generic adoption, expanding access	Competition from integrase inhibitors
2025	2.3	2.3%	HIV treatment scale-up in emerging markets	Safety profile concerns
2027	2.5	2.2%	Incremental gains from formulation improvements	Regulatory hurdles for new formulations
2030	2.65	2.5%	Global HIV epidemic control efforts	Market saturation in developed countries

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Comparison with Competitive Agents

Agent	Class	Advantages	Disadvantages	Market Share (2023 est.)
Dolutegravir (Tivicay)	Integrase inhibitor	Superior tolerability, higher barrier to resistance	Cost, resistance in rare cases	~40%
Efavirenz (Sustiva)	NNRTI	Long-established efficacy, low cost	Neuropsychiatric side effects	~20%
Rilpivirine (Edurant)	NNRTI	Better tolerability than efavirenz	Less effective in high viral load	~10%
Bictegravir (Biktarvy)	Integrase inhibitor	Once-daily, high potency	Cost	Increasing

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Regulatory and Policy Landscape

Region	Regulatory Status	Policies Affecting Efavirenz Market	Notes
US	Approved	CDC guidelines favor integrase inhibitors	Efavirenz remains an option for certain populations
EU	Approved	EMA emphasizes tolerability improvements	Use in fixed-dose combinations
Africa	Widely accepted	WHO recommends efavirenz-based first-line therapy	Major role in HIV/AIDS control programs
Asia	Varies	Regulatory approval depends on local authorities	Market expansion through generics

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Key Challenges Impacting Sustiva Market

• Safety Concerns: Neuropsychiatric adverse events influence clinician prescribing behaviors.
• Market Competition: Growing preference for integrase inhibitors, especially in developed markets.
• Regulatory and Policy Shifts: Global moves towards newer therapies may reduce efavirenz’s role.
• Patent and Patent Expiry: Accelerates generic competition, impacting pricing and profitability.

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Opportunities for Growth and Innovation

• Formulation Improvements: Development of Extended-Release formulations to improve adherence.
• Combination Therapies: Fixed-dose combinations with newer agents to enhance tolerability.
• Expanded Use Cases: Exploring efavirenz as part of pre-exposure prophylaxis (PrEP) in specific populations.
• Geographical Expansion: Increasing access in low- and middle-income countries with generic formulations.

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Conclusion

While efavirenz (Sustiva) continues to hold a significant position within the HIV therapeutic landscape, its future growth is increasingly challenged by safety profiles and competition from newer agents. Clinical trials are focusing on optimizing formulations and expanding utility, providing opportunities to maintain market relevance. Strategic considerations should include leveraging its cost-effectiveness, addressing tolerability issues, and exploring combination therapies to extend its lifecycle.

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Key Takeaways

• Sustiva’s market remains substantial but faces headwinds from advances in HIV treatment.
• Ongoing clinical trials target improving tolerability and expanding indications.
• The global efavirenz market is projected to grow modestly (~2.5% CAGR) through 2030.
• Patent expirations and generic entry continue to drive price reductions.
• Strategic focus should incorporate formulation optimization, new combination therapies, and geographic expansion.

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FAQs

1. What are the main clinical developments for efavirenz in recent years?
Recent studies have concentrated on improving formulation tolerability, assessing long-term safety, and exploring new combination therapies. Some trials are evaluating sustained-release formulations to enhance adherence, while regulatory updates emphasize managing neuropsychiatric adverse events.

2. How does efavirenz compare to newer antiretroviral agents?
Efavirenz offers a proven efficacy profile and cost advantage but is generally less well-tolerated than integrase inhibitors like dolutegravir and bictegravir. Safety concerns, particularly neuropsychiatric effects, have shifted prescribing trends toward newer agents with better tolerability.

3. What is the impact of generic competition on Sustiva’s market?
Post-patent expiry in 2018, generics now dominate sales, reducing prices by up to half. This has increased access in low- and middle-income countries but has compressed profit margins for branded formulations.

4. Are there new indications or formulations being explored for efavirenz?
Yes, ongoing trials investigate extended-release formulations aimed at improving adherence, and some exploratory studies assess efavirenz’s role in PrEP, though these are not yet approved for such uses.

5. What policy factors influence efavirenz’s future market?
Treatment guidelines (e.g., WHO, CDC), safety profile concerns, and regulatory approvals are primary drivers. A global shift favors integrase inhibitors, though efavirenz remains relevant in settings with limited resources.

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References

[1] Johnson, L. et al. (2022). Long-term safety and tolerability of efavirenz: A 10-year cohort study. J Acquir Immune Defic Syndr.
[2] WHO. (2021). Consolidated guidelines on HIV prevention, testing, treatment, service delivery and monitoring.
[3] GlobalData. (2023). HIV antiretroviral drugs market analysis and forecast.
[4] U.S. Food & Drug Administration. (2021). Efavirenz prescribing information.
[5] EMA. (2022). Summary of product characteristics for efavirenz.