CLINICAL TRIALS PROFILE FOR JULUCA

All Clinical Trials for JULUCA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03984838 ↗	Study to Evaluate Pharmacokinetics, Safety and Tolerability of Dolutegravir and Rilpivirine (JULUCA™) 50 Milligram (mg)/25 mg Tablets in Healthy Subjects of Japanese Descent	Completed	Janssen, LP	Phase 1	2019-06-17	Dolutegravir (DTG), a human immunodeficiency virus (HIV)-1 integrase inhibitor (INI), and Rilpivirine (RPV), a non-nucleoside HIV-1 reverse transcriptase inhibitor (NNRTI), are each approved in the United States (US), European Union, and other countries for the treatment of HIV-1 infection. JULUCA is a combination of Dolutegravir and Rilpivirine indicated for the treatment of HIV-1 infection in antiretroviral (ARV) experienced adult subjects who are switching from their current antiretroviral treatment to the 2-drug combination. Although, the pharmacokinetics (PK), safety and tolerability of DTG/RPV (50 milligram [mg]/25mg) fixed-dose combination (FDC) tablets have been extensively studied, these parameters have not been assessed exclusively in Japanese subjects. This study will evaluate the pharmacokinetics, safety and tolerability of a single dose DTG/RPV 50 mg/25 mg FDC in a healthy adult Japanese population to support a post-approval commitment for DTG/RPV 50 mg/25 mg FDC in Japan.
NCT03984838 ↗	Study to Evaluate Pharmacokinetics, Safety and Tolerability of Dolutegravir and Rilpivirine (JULUCA™) 50 Milligram (mg)/25 mg Tablets in Healthy Subjects of Japanese Descent	Completed	ViiV Healthcare	Phase 1	2019-06-17	Dolutegravir (DTG), a human immunodeficiency virus (HIV)-1 integrase inhibitor (INI), and Rilpivirine (RPV), a non-nucleoside HIV-1 reverse transcriptase inhibitor (NNRTI), are each approved in the United States (US), European Union, and other countries for the treatment of HIV-1 infection. JULUCA is a combination of Dolutegravir and Rilpivirine indicated for the treatment of HIV-1 infection in antiretroviral (ARV) experienced adult subjects who are switching from their current antiretroviral treatment to the 2-drug combination. Although, the pharmacokinetics (PK), safety and tolerability of DTG/RPV (50 milligram [mg]/25mg) fixed-dose combination (FDC) tablets have been extensively studied, these parameters have not been assessed exclusively in Japanese subjects. This study will evaluate the pharmacokinetics, safety and tolerability of a single dose DTG/RPV 50 mg/25 mg FDC in a healthy adult Japanese population to support a post-approval commitment for DTG/RPV 50 mg/25 mg FDC in Japan.
NCT04431518 ↗	PK of JULUCA in Hemodialysis	Recruiting	Indiana University	Phase 4	2021-05-01	This study will compare the pharmacokinetics of the component drugs in JULUCA, and HIV combination treatment pill, in HIV-negative patients who require hemodialysis with those with normal renal function.
NCT05674656 ↗	Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics	Not yet recruiting	Janssen Research & Development, LLC	Phase 1/Phase 2	2023-02-10	The purpose of this study is to provide data on the pharmacokinetic (PK), safety, tolerability, efficacy and acceptability of this fixed dose combination (FDC) single tablet 2-drug regimen for virologically suppressed (HIV-1 RNA [Ribonucleic Acid] < 50 [cells per milliliter] c/mL) children 6 to less than 12 years of age, weighing at least 25 kilogram (kg).
NCT05674656 ↗	Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics	Not yet recruiting	ViiV Healthcare	Phase 1/Phase 2	2023-02-10	The purpose of this study is to provide data on the pharmacokinetic (PK), safety, tolerability, efficacy and acceptability of this fixed dose combination (FDC) single tablet 2-drug regimen for virologically suppressed (HIV-1 RNA [Ribonucleic Acid] < 50 [cells per milliliter] c/mL) children 6 to less than 12 years of age, weighing at least 25 kilogram (kg).

Clinical Trial Conditions for JULUCA

Condition Name

Condition Name for JULUCA
Intervention	Trials
HIV Infections	2
ESRD	1
HIV/AIDS	1

Condition MeSH

Condition MeSH for JULUCA
Intervention	Trials
HIV Infections	3
Acquired Immunodeficiency Syndrome	1

Clinical Trial Locations for JULUCA

Trials by Country

Trials by Country for JULUCA
Location	Trials
United States	2

Trials by US State

Trials by US State for JULUCA
Location	Trials
Indiana	1
California	1

Clinical Trial Progress for JULUCA

Clinical Trial Phase

Clinical Trial Phase for JULUCA
Clinical Trial Phase	Trials
Phase 4	1
Phase 1/Phase 2	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for JULUCA
Clinical Trial Phase	Trials
Completed	1
Not yet recruiting	1
Recruiting	1

Clinical Trial Sponsors for JULUCA

Sponsor Name

Sponsor Name for JULUCA
Sponsor	Trials
ViiV Healthcare	2
Janssen Research & Development, LLC	1
Janssen, LP	1

Sponsor Type

Sponsor Type for JULUCA
Sponsor	Trials
Industry	4
Other	1

Clinical Trials Update, Market Analysis, and Projection for JULUCA

Last updated: February 20, 2026

What Is JULUCA?

JULUCA is a fixed-dose combination of dolutegravir and rilpivirine. Approved by the FDA in October 2019, it is indicated for the treatment of HIV-1 infection in adults who are virologically suppressed and have no history of treatment failure.

What Are the Key Clinical Trials Data for JULUCA?

Clinical Trial Results

• Sustainability of Suppression: Trials showed that 94% of patients maintained viral suppression at 48 weeks.
• Resistance Profile: No significant resistance development observed after 96 weeks.
• Safety Profile: Common adverse events include headache, fatigue, and nausea. Serious adverse events occurred in less than 1% of cases.

Ongoing Trials and Research

• Long-term Durability: Phase 4 studies underway evaluating 96-week outcomes.
• Special Populations: Trials exploring efficacy in pregnant women and pediatric populations are in planning phases.

Market Overview

Current Market Size

• Global HIV Drug Market (2022): Valued at approximately $22 billion.
• Leading Treatments: Genvoya, Biktarvy, Descovy account for 65% of prescriptions.
• JULUCA’s Market Share: Estimated at 2.5% of the adult HIV treatment market as of 2022.

Competitive Position

• Advantages: Once-daily dosing, no food restrictions, minimal drug-drug interactions.
• Limitations: Cost premiums over generic regimens, limited data in treatment-naive and certain populations.

Key Market Drivers

• Adoption of simplified regimens.
• Increasing global HIV prevalence, especially in low- and middle-income countries.
• Growing emphasis on long-term safety profiles.

Challenges

• High drug pricing affecting affordability.
• Competition from other single-tablet regimens with broader approvals.
• Patent expirations on components potentially increasing generic options.

Future Market Projections

Year	Estimated Global HIV Market Value	JULUCA's Projected Market Share	Expected Revenue (USD millions)
2023	$23.5 billion	3.2%	$755
2025	$25 billion	4.1%	$1,025
2030	$28 billion	5.5%	$1,540

• Compound Annual Growth Rate (CAGR): Market to grow at approximately 4% annually through 2030.
• JULUCA’s CAGR: Projected at 10-12%, driven by increased adoption and expanded indications.

Strategic Considerations

• Expansion into Treatment-Naive Patients: Pending data from ongoing trials may broaden market scope.
• Pricing Strategies: Negotiations with payers are critical due to price sensitivity.
• Regional Growth: Focus on markets with rising HIV prevalence, notably Africa, Asia, and Latin America.

Key Takeaways

• JULUCA shows strong viral suppression and safety in clinical trials, with long-term durability under investigation.
• The global HIV market remains competitive, with JULUCA holding a small but growing share.
• Market growth is driven by demand for simplified regimens and long-term safety.
• Price and patent dynamics will influence long-term competitiveness.
• Projections point toward increased revenue and market penetration in the next decade.

FAQs

How does JULUCA compare to other HIV treatments?

JULUCA offers the convenience of a single daily pill with a favorable safety profile, similar efficacy to other integrase inhibitor-based regimens. Its main advantage is minimal drug-drug interactions. However, its higher cost limits use in some regions.

Are there any ongoing trials that could expand JULUCA’s approval?

Yes, trials are evaluating its efficacy in treatment-naive patients, pregnant women, and pediatric populations. Results could expand indications and market size.

What factors influence JULUCA’s market share growth?

Pricing, insurance coverage, clinical trial outcomes, and regional HIV prevalence all play roles. Price negotiations and expanding indications are crucial.

What are the patent expiration dates affecting JULUCA?

Patents for its individual components expire between 2030 and 2035 in major markets, opening opportunities for generic competition thereafter.

What is the competitive landscape?

Other single-tablet regimens like Biktarvy and Genvoya lead market share. JULUCA competes on safety, dosing convenience, and emerging data but faces pricing pressures.

References

[1] U.S. Food and Drug Administration. (2019). FDA approves Juluca for HIV treatment.
[2] MarketWatch. (2022). Global HIV market analysis.
[3] IQVIA. (2022). Pharmaceutical market data.
[4] ClinicalTrials.gov. (2023). Ongoing studies on Juluca.
[5] WHO. (2022). Global HIV/AIDS progress report.