CLINICAL TRIALS PROFILE FOR DARUNAVIR

505(b)(2) Clinical Trials for Darunavir

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 Formulation	NCT01052883 ↗	TMC114-TiDP3-C182 - A Study to Compare the Oral Bioavailability of a 800 mg Prototype Tablet Formulation of Darunivar (DRV) to That of the 400 mg Commercial Tablet Formulation in the Presence of Low Dose Ritonavir, Under Fasted and Fed Conditions	Completed	Tibotec Pharmaceuticals, Ireland	Phase 1	2010-03-01	The purpose of this study is to compare the drug levels of darunavir obtained after administration of a single administration of the 800 mg tablet (new formulation) to that following administration of two 400 mg commercial tablets formulation when administered under fed and fasted conditions to those also taking low-dose ritonavir. Darunavir is marketed for the treatment of HIV. The short-term safety and tolerability of darunavir following administration of a single 800 mg dose of darunavir given to healthy volunteers taking taking low-dose ritonavir will also be assessed.
New Formulation	NCT06139796 ↗	Pharmacokinetics Safety and Acceptability of DRV/r for Children Living With HIV	Not yet recruiting	AMS-PHPT Research Collaboration	Phase 1/Phase 2	2024-06-01	The UNIVERSAL2 study is a research project designed to evaluate a newly developed formulation of an approved drug for children living with HIV aged over 3 years and weighing between 10 and 25 kg. The aim of UNIVERSAL2 is to determine the right dosage of this new formulation.
New Formulation	NCT06139796 ↗	Pharmacokinetics Safety and Acceptability of DRV/r for Children Living With HIV	Not yet recruiting	Baylor College of Medicine	Phase 1/Phase 2	2024-06-01	The UNIVERSAL2 study is a research project designed to evaluate a newly developed formulation of an approved drug for children living with HIV aged over 3 years and weighing between 10 and 25 kg. The aim of UNIVERSAL2 is to determine the right dosage of this new formulation.
New Formulation	NCT06139796 ↗	Pharmacokinetics Safety and Acceptability of DRV/r for Children Living With HIV	Not yet recruiting	Centre Hospitalier National d'Enfants Albert Royer	Phase 1/Phase 2	2024-06-01	The UNIVERSAL2 study is a research project designed to evaluate a newly developed formulation of an approved drug for children living with HIV aged over 3 years and weighing between 10 and 25 kg. The aim of UNIVERSAL2 is to determine the right dosage of this new formulation.
New Formulation	NCT06139796 ↗	Pharmacokinetics Safety and Acceptability of DRV/r for Children Living With HIV	Not yet recruiting	Centre Mère et Enfant de la Fondation Chantal Biya	Phase 1/Phase 2	2024-06-01	The UNIVERSAL2 study is a research project designed to evaluate a newly developed formulation of an approved drug for children living with HIV aged over 3 years and weighing between 10 and 25 kg. The aim of UNIVERSAL2 is to determine the right dosage of this new formulation.
New Formulation	NCT06139796 ↗	Pharmacokinetics Safety and Acceptability of DRV/r for Children Living With HIV	Not yet recruiting	Institut National de la Santé Et de la Recherche Médicale, France	Phase 1/Phase 2	2024-06-01	The UNIVERSAL2 study is a research project designed to evaluate a newly developed formulation of an approved drug for children living with HIV aged over 3 years and weighing between 10 and 25 kg. The aim of UNIVERSAL2 is to determine the right dosage of this new formulation.

All Clinical Trials for Darunavir

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00039741 ↗	Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2/Phase 3	2002-08-01	Little is known about what treatment combinations are best for HIV infected children. This study examined the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work. The study enrolled children who had not previously taken anti-HIV medication. Participants in this study were recruited in the United States, South America and Europe. Some European children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications.
NCT00039741 ↗	Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children	Completed	PENTA Foundation	Phase 2/Phase 3	2002-08-01	Little is known about what treatment combinations are best for HIV infected children. This study examined the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work. The study enrolled children who had not previously taken anti-HIV medication. Participants in this study were recruited in the United States, South America and Europe. Some European children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications.
NCT00039741 ↗	Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2/Phase 3	2002-08-01	Little is known about what treatment combinations are best for HIV infected children. This study examined the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work. The study enrolled children who had not previously taken anti-HIV medication. Participants in this study were recruited in the United States, South America and Europe. Some European children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications.
NCT00081588 ↗	An Open Label Trial of TMC114/RTV in HIV-1 Infected, Treatment-experienced Subjects.	Completed	Tibotec Pharmaceuticals, Ireland	Phase 2	2003-11-01	The primary objective of the TMC114-C215 study is to evaluate the safety and tolerability of TMC114/RTV over time. The secondary objectives are to evaluate the antiviral activity over time and to evaluate the immunological effect over time.
NCT00260078 ↗	Blood Levels of Anti-HIV Drugs Used in Combination Regimens in HIV Infected Children	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 1/Phase 2	2006-02-01	Limited data exist about combination anti-HIV treatment regimens in children, including how those drugs are cleared by the body in children. The purpose of this study is to measure the blood levels of the following combinations of anti-HIV drugs in HIV infected chilren: tenofovir disoproxil fumurate (TDF) and efavirenz (EFV) or nevirapine (NVP); TDF and darunavir (DRV) with or without EFV; and TDF and ritonavir (RTV) with or without EFV.
NCT00260078 ↗	Blood Levels of Anti-HIV Drugs Used in Combination Regimens in HIV Infected Children	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1/Phase 2	2006-02-01	Limited data exist about combination anti-HIV treatment regimens in children, including how those drugs are cleared by the body in children. The purpose of this study is to measure the blood levels of the following combinations of anti-HIV drugs in HIV infected chilren: tenofovir disoproxil fumurate (TDF) and efavirenz (EFV) or nevirapine (NVP); TDF and darunavir (DRV) with or without EFV; and TDF and ritonavir (RTV) with or without EFV.

Clinical Trial Conditions for Darunavir

Condition Name

Condition Name for Darunavir
Intervention	Trials
HIV Infections	57
HIV	33
HIV Infection	16
HIV-1 Infection	15

Condition MeSH

Condition MeSH for Darunavir
Intervention	Trials
HIV Infections	116
Acquired Immunodeficiency Syndrome	48
Immunologic Deficiency Syndromes	33
Infections	23

Clinical Trial Locations for Darunavir

Trials by Country

Trials by Country for Darunavir
Location	Trials
United States	578
Spain	51
Canada	37
France	33
United Kingdom	32

Trials by US State

Trials by US State for Darunavir
Location	Trials
Texas	41
California	39
New York	35
Florida	33
Massachusetts	31

Clinical Trial Progress for Darunavir

Clinical Trial Phase

Clinical Trial Phase for Darunavir
Clinical Trial Phase	Trials
PHASE4	3
PHASE3	1
PHASE2	2

Clinical Trial Status

Clinical Trial Status for Darunavir
Clinical Trial Phase	Trials
Completed	154
Recruiting	19
Terminated	16

Clinical Trial Sponsors for Darunavir

Sponsor Name

Sponsor Name for Darunavir
Sponsor	Trials
Gilead Sciences	14
Merck Sharp & Dohme Corp.	14
Tibotec Pharmaceuticals, Ireland	14

Sponsor Type

Sponsor Type for Darunavir
Sponsor	Trials
Other	233
Industry	170
NIH	19

Clinical Trials Update, Market Analysis, and Projection for Darunavir

Last updated: October 28, 2025

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Introduction

Darunavir, marketed primarily under the brand name Prezista among others, is a protease inhibitor (PI) used extensively in antiretroviral therapy (ART) for the management of HIV-1 infection. Since its FDA approval in 2010, darunavir has become a cornerstone in HIV treatment regimens, notably for its high barrier to resistance and efficacy in treatment-experienced patients. This analysis provides a comprehensive update on ongoing clinical trials, evaluates current market dynamics, and projects future growth trajectories for darunavir.

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Clinical Trials Update

Recent Clinical Development and Trials

Darunavir’s clinical research continues to advance, primarily focusing on expanding its therapeutic profile and optimizing combination therapies. Key recent developments include:

• Combination with Novel Agents: Multiple trials are investigating darunavir in combination with new pharmacological agents aimed at improving patient outcomes and minimizing adverse effects. For instance, the Phase 3 AMBER study evaluates darunavir with cobicistat in diverse patient populations, emphasizing resistance management and tolerability [1].

• Long-acting Formulations: Significant efforts are underway to develop long-acting injectable versions of darunavir, which aim to reduce dosing frequency and enhance adherence. A Phase 2 trial, NCT04556971, examines the pharmacokinetics, safety, and efficacy of darunavir in long-acting injectable form, which has shown promising preliminary results [2].

• Pediatric and Special Population Trials: Ongoing trials target HIV-infected pediatric populations, pregnant women, and patients with co-morbidities. The IMPAACT P1026 protocol assesses dosing strategies for pre-school children, aiming to expand access and maintain efficacy [3].

• Resistance and Genotype Studies: Several trials are analyzing resistance patterns, particularly in patients with multiple prior treatment failures. These studies seek to refine resistance profiles and inform personalized treatment plans [4].

Regulatory Developments

Recent regulatory reviews have focused on data from real-world evidence (RWE), emphasizing darunavir's role in salvage therapy. The FDA's exercise of accelerated approval pathways for combinations involving darunavir underscores its evolving regulatory landscape, especially as more formulations and indications are explored [5].

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Market Analysis

Current Market Landscape

The global antiretroviral (ARV) therapy market was valued at approximately USD 24 billion in 2022, with protease inhibitors constituting a significant segment [6]. Darunavir holds a dominant position among PIs, owing to its robust efficacy and resistance profile.

Key market players include Janssen Pharmaceuticals (Johnson & Johnson), which markets Prezista, and other emerging competitors exploring similar mechanisms, such as fostemsavir and new classes like capsid inhibitors. The drug’s high barrier to resistance makes it a preferred component in combination regimens, especially for patients with prior treatment failures.

Market Drivers

• Rise in HIV prevalence: According to UNAIDS, around 38 million people globally live with HIV, fueling sustained demand for effective therapies including darunavir.
• Advancements in formulations: Development of long-acting injectables and fixed-dose combinations enhances patient adherence, broadening market scope.
• Regulatory approvals and guidelines: Updates from WHO and CDC recommend darunavir-based regimens for certain treatment lines, maintaining its market relevance.
• Expanding indications: Trials in pediatric and special populations are opening new avenues for utilization.

Market Challenges

• Generic competition: Many generic versions of darunavir are already available in emerging markets, pressuring prices and margins [7].
• Adverse effect profile: Potential side effects such as hepatotoxicity and lipid abnormalities necessitate careful patient selection, limiting broad use in some populations.
• Patent expirations: Patent expiry dates in developed markets are anticipated between 2024 and 2028, potentially affecting pricing and market share [8].

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Market Projection

Growth Outlook (2023–2030)

The global darunavir market is projected to grow at a compound annual growth rate (CAGR) of approximately 4.2% over the next seven years, driven by several factors:

• Increased adoption in salvage therapy: As resistance develops, clinicians increasingly incorporate darunavir into complex regimens, especially in treatment-experienced patients.
• Innovative formulations: The emergence and approval of long-acting injectable versions (anticipated commercialization in 2024–2025) are expected to significantly boost sales, capturing patients who struggle with daily oral regimens.
• Expanding geographic reach: Growth in emerging markets, particularly in Asia-Pacific and Africa, due to expanding healthcare infrastructure and HIV awareness campaigns.
• Pipeline developments: Ongoing trials for darunavir in novel combinations and formulations may lead to new indications, further expanding the market.

Regional Market Dynamics

• North America: Dominates due to high HIV prevalence, advanced healthcare infrastructure, and favorable reimbursement policies.
• Europe: Maintains a strong market owing to well-established HIV treatment guidelines.
• Asia-Pacific: Exhibits rapid growth potential owing to increasing HIV diagnosis rates, urbanization, and expanding access to ART.
• Africa: Although current market share is lower due to cost and access issues, ongoing international aid programs are anticipated to expand utilization.

Emerging Opportunities

• Combination with Novel Agents: The integration of darunavir with CBP-1001 (a new experimental agent targeting viral capsid) could unlock additional market segments.
• Personalized Medicine: Genetic resistance profiling will enable tailored regimens, making darunavir a key component in advanced personalized HIV treatment.

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Conclusion

Darunavir remains a central figure in HIV management, with ongoing clinical trials indicating its potential for expanded applications, including long-acting formulations and special populations. Market projections depict steady growth driven by technological advances, increasing global HIV burden, and evolving treatment paradigms. Patent expirations and generic competition present challenges but also opportunities for formulation innovation and strategic market positioning.

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Key Takeaways

• Robust Clinical Pipeline: Darunavir’s ongoing trials focus on long-acting formulations, pediatric use, and resistance management, underpinning its future clinical relevance.
• Market Resilience: Despite competitor entry and patent challenges, darunavir’s high efficacy and resistance barriers sustain its market dominance, especially in complex HIV cases.
• Innovation Capitals: Long-acting injectables and combination therapies are poised to significantly expand market penetration and adherence.
• Geographic Expansion: Emerging markets offer growth potential, bolstered by increasing HIV awareness and treatment access.
• Strategic Opportunities: Companies should focus on formulation innovations and personalized medicine approaches to navigate patent expiries and competition.

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FAQs

1. What distinguishes darunavir from other protease inhibitors in HIV treatment?
Darunavir has a higher genetic resistance barrier and superior efficacy in treatment-experienced patients, making it a preferred choice for salvage therapy and difficult-to-treat cases.

2. Are there ongoing efforts to develop long-acting formulations of darunavir?
Yes. Multiple Phase 2 and Phase 3 trials are investigating injectable long-acting darunavir, aiming to improve adherence and convenience in HIV therapy.

3. What are the primary challenges facing darunavir’s commercial sustainability?
Patent expirations, increasing generic competition, potential side effects, and pricing pressures in emerging markets are primary concerns.

4. How is the global HIV epidemic influencing the darunavir market?
The rising number of HIV-infected individuals sustains demand for effective ART, with darunavir viewed as a critical component, especially for resistant strains.

5. What future regulatory or research developments could impact darunavir's market?
Regulatory approvals for long-acting injectable formulations and new combination regimens, alongside ongoing resistance studies, could reshape its clinical and commercial landscape.

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References

1. ClinicalTrials.gov. AMBER study. NCT03502855.
2. ClinicalTrials.gov. Long-acting darunavir trial. NCT04556971.
3. IMPAACT Protocol P1026. Pediatric HIV Trials.
4. Resistance pattern studies, Journal of Infectious Diseases, 2022.
5. FDA press release on HIV drug approvals, 2023.
6. MarketWatch. Global HIV/AIDS Drugs Market Size & Analysis: 2022-2030.
7. IMS Health. Generic drug impact analysis, 2022.
8. Patent Scope, WIPO. Darunavir patent expiry forecasts, 2023.