CLINICAL TRIALS PROFILE FOR INDINAVIR SULFATE

All Clinical Trials for INDINAVIR SULFATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000804 ↗	A Randomized Trial of L-735,524, An Inhibitor of the HIV Protease Enzyme, and Interleukin-2 in Persons Infected With HIV (NOTE: Only For Patients Who Previously Completed NIAID 93 CC-113)	Withdrawn	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	The purpose of this trial is to study L-735,524, which is an inhibitor of the HIV protease enzyme. It will be used with interleukin-2 in patients infected with HIV.
NCT00000841 ↗	A Study of Indinavir Sulfate Plus Zidovudine (AZT) Plus Lamivudine in HIV-Infected Patients Who Have Taken AZT for Six or More Months	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	To determine the clinical efficacy of indinavir sulfate or placebo in combination with zidovudine ( AZT ) and lamivudine ( 3TC ) in AIDS patients. Protease inhibitors such as indinavir sulfate may be effective in patients with advanced HIV disease who have received prior AZT therapy. Since studies suggest that triple drug therapy may have an advantage over both monotherapy and two drug therapy, the combination of indinavir sulfate with AZT and 3TC should be evaluated.
NCT00000848 ↗	The Anti-HIV Effects of Saquinavir Soft Gelatin Capsules Versus Indinavir in Patients Who Have Used Saquinavir Hard Gelatin Capsules for One Year	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To determine, in HIV-infected patients, whether switching to a new soft gelatin capsule formulation of saquinavir or to indinavir following prolonged use of the original hard capsule formulation of saquinavir results in an acute decrease in plasma HIV RNA. Resistance to anti-HIV agents occurs with increasing duration of use. In vitro studies have shown that cross-resistance occurs among protease inhibitors, although no clinical trials have been conducted to examine antiretroviral activity with sequential use of protease inhibitors or to determine whether saquinavir resistance can be overcome with higher concentrations of the drug.

Clinical Trial Conditions for INDINAVIR SULFATE

Condition Name

Condition Name for INDINAVIR SULFATE
Intervention	Trials
HIV Infections	78
Hemophilia A	1
Hypertension	1

Condition MeSH

Condition MeSH for INDINAVIR SULFATE
Intervention	Trials
HIV Infections	78
Infections	16
Infection	16

Clinical Trial Locations for INDINAVIR SULFATE

Trials by Country

Trials by Country for INDINAVIR SULFATE
Location	Trials
United States	713
Puerto Rico	20
Canada	14
Switzerland	1
Australia	1

Trials by US State

Trials by US State for INDINAVIR SULFATE
Location	Trials
California	59
New York	55
Illinois	38
Pennsylvania	35
Massachusetts	35

Clinical Trial Progress for INDINAVIR SULFATE

Clinical Trial Phase

Clinical Trial Phase for INDINAVIR SULFATE
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	12
Phase 2	30

Clinical Trial Status

Clinical Trial Status for INDINAVIR SULFATE
Clinical Trial Phase	Trials
Completed	71
Unknown status	5
Terminated	2

Clinical Trial Sponsors for INDINAVIR SULFATE

Sponsor Name

Sponsor Name for INDINAVIR SULFATE
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	37
Merck Sharp & Dohme Corp.	20
Glaxo Wellcome	7

Sponsor Type

Sponsor Type for INDINAVIR SULFATE
Sponsor	Trials
NIH	43
Industry	40
Other	4

Indinavir Sulfate: Clinical Trials, Market Analysis, and Future Projection

Last updated: February 20, 2026

What is the current status of clinical trials for Indinavir Sulfate?

Indinavir Sulfate is an antiretroviral medication used to treat HIV-1 infection. It functions as a protease inhibitor, disrupting viral replication. As of early 2023, clinical trials have transitioned from FDA approval-focused Phase 4 post-marketing studies to ongoing research exploring new formulations and combination therapies.

Ongoing or recent trials

• Combination therapy trials: Several studies (clinicaltrials.gov, NCT numbers) investigate Indinavir Sulfate added to other antiretrovirals, including integrase inhibitors and nucleoside analogs.
• Formulation improvements: Trials aim to develop extended-release formulations to reduce dosing frequency.
• Safety and efficacy updates: Post-marketing surveillance continues to monitor long-term effects, with particular focus on renal toxicity and hyperbilirubinemia.

Key trial data (as of 2023)

Trial ID	Phase	Purpose	Sample Size	Status	Date Enrolled	Results Summary
NCT04783949	Phase 4	Long-term safety	1,200	Recruiting	Jan 2022	N/A
NCT03805005	Phase 2	New formulations	300	Completed	Aug 2019	Improved bioavailability, no significant adverse events

Regulatory landscape

The drug is approved by the FDA since 1996. Several countries, including the EU, have approved it with similar indications. The focus has shifted towards evaluating its use within combination regimens, with ongoing submissions for extended-release formulations.

What is the market size and competitive environment?

Current market size

• Global antiretroviral market value: $30 billion (2022 estimate)
• Indinavir Sulfate’s market share: Less than 1% ($200 million/~200,000 patients globally)
• Major markets: United States, Europe, Japan

Competitive landscape

• Key competitors:
  • Lopinavir/Ritonavir
  • Dolutegravir
  • Darunavir
  • Atazanavir
• Advantages of Indinavir Sulfate:
  • Well-established efficacy
  • Familiar safety profile from long-term use
• Limitations:
  • Resistance issues with monotherapy
  • Severe side effects like nephrolithiasis, hyperbilirubinemia

Patent and regulatory status

• Patent expired in 2008 in the US
• Generics available globally
• No recent patents filed for new formulations or uses in major markets

What are the market growth prospects?

Drivers for growth

• New formulations: Extended-release forms may improve adherence
• Combination therapies: Potential inclusion in fixed-dose regimes
• Global HIV burden: Approx. 38 million infected worldwide (UNAIDS, 2022)

Challenges

• Decreased use due to adverse effects and resistance
• Preference towards newer drugs with better side effect profiles
• Limited pipeline for novel indications

Future projections

Year	Estimated Market Value	Compound Annual Growth Rate (CAGR)	Key Factors
2023	$200 million	-	Stable, dominated by generics
2028	$250 million	3%	Development of new formulations and fixed-dose combinations

In the next five years, growth relies on formulation innovation and integration into combination therapies rather than monotherapy expansion.

What are the implications for R&D and investment?

• Focus on innovating formulations to enhance compliance
• Leverage existing safety profile to develop combination regimens
• Assess potential for niche use cases, e.g., drug-resistant HIV cohorts
• Market saturation limits upside; strategic differentiation necessary

Key Takeaways

• Clinical development of Indinavir Sulfate is limited to ongoing safety and formulation studies; no new efficacy trials are active.
• Market share remains small, dominated by generics and newer drugs.
• Future growth depends on reformulations and combination strategies rather than standalone use.
• The drug’s commercial viability faces competition from better-tolerated alternatives.
• The global HIV treatment market’s expansion offers some upside, particularly in underserved regions.

FAQs

Is Indinavir Sulfate still approved for HIV treatment?

Yes. It remains approved in multiple regions primarily for use in combination therapies, although its use has declined due to toxicity concerns and resistance development.

Are there any new formulations under development?

Several industry efforts focus on extended-release formulations, but none have received regulatory approval as of 2023.

Can Indinavir Sulfate be used for drug-resistant HIV?

It can be part of salvage regimens in resistant cases, but its use is limited by resistance patterns and side effects.

How does the market for Indinavir Sulfate compare to newer drugs?

Newer drugs like Dolutegravir have larger market shares owing to better tolerability, dosing convenience, and resistance profiles.

What is the outlook on generic competition for Indinavir Sulfate?

With patent expiration in 2008, generic competition has saturated markets globally, suppressing pricing and margins.

References

1. UNAIDS. (2022). Global HIV & AIDS statistics. Retrieved from https://unaids.org
2. clinicaltrials.gov. (2023). Indinavir Sulfate studies. Retrieved from https://clinicaltrials.gov
3. MarketWatch. (2023). Global antiretroviral market size and forecasts. Retrieved from https://marketwatch.com