CLINICAL TRIALS PROFILE FOR RITONAVIR

505(b)(2) Clinical Trials for Ritonavir

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	NCT00196625 ↗	Salvage Therapy With Amprenavir, Lopinavir and Ritonavir in HIV-Infected Patients in Virological Failure.	Completed	French National Agency for Research on AIDS and Viral Hepatitis	Phase 2	2000-11-01	HIV infected patients are treated with highly active antiretroviral therapy (HAART). Side effects and the great number of pills reduces adherence to the treatment, and induces therapeutic failure. In order to maintain efficacy of HAART, new combination is evaluated. The aim of the study is to compare the antiviral efficacy of this salvage therapy combining lopinavir and amprenavir with 200 mg/d or 400 mg/d ritonavir, together with nucleoside reverse transcriptase inhibitors, over a 26-week period in HIV-infected patients in whom multiple antiretroviral regimens had failed.
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	NCT02244190 ↗	Bioequivalence of Two Different Oral Solutions Tipranavir Administered in Combination With Ritonavir to Healthy Volunteers	Completed	Boehringer Ingelheim	Phase 1	2008-04-01	To establish the bioequivalence of the new tipranavir oral solution formulation with the current tipranavir oral solution formulation following single-dose administration. In each case, 500 mg tipranavir was coadministered with 200 mg ritonavir.

All Clinical Trials for Ritonavir

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000822 ↗	A Phase I/II Double-Blind Controlled Trial to Determine the Safety and Immunogenicity of HIV-1 MN rgp160 Immuno AG Vaccine Therapy in HIV-Infected Individuals With Greater Than or Equal to 500/mm3 CD4+ T Cells and 200-400/mm3 CD4+ T Cells	Completed	Bristol-Myers Squibb	Phase 1	1969-12-31	To evaluate the safety and immunogenicity of HIV-1 MN rgp160 (Immuno-AG) in HIV-infected patients. To evaluate the immunogenicity of HIV-1 MN rgp160 immunogen by lymphocyte proliferation, specific antibody responses, and DTH reaction. To describe the durability of the immunogen in patients who respond to the first 7 injections when they are boosted every 8 weeks for an additional 6-12 months [AS PER AMENDMENT 11/12/96: stratum 1 patients only]. To describe the ability of the immunogen to induce a response after an additional 6-12 months of injections among patients who did not respond to the first 7 injections [AS PER AMENDMENT 11/12/96: stratum 1 patients only]. HIV-specific cellular immune responses appear to play an important role in HIV disease progression since both T helper and cytotoxic function against HIV decrease with disease progression.
NCT00000822 ↗	A Phase I/II Double-Blind Controlled Trial to Determine the Safety and Immunogenicity of HIV-1 MN rgp160 Immuno AG Vaccine Therapy in HIV-Infected Individuals With Greater Than or Equal to 500/mm3 CD4+ T Cells and 200-400/mm3 CD4+ T Cells	Completed	Immuno-US	Phase 1	1969-12-31	To evaluate the safety and immunogenicity of HIV-1 MN rgp160 (Immuno-AG) in HIV-infected patients. To evaluate the immunogenicity of HIV-1 MN rgp160 immunogen by lymphocyte proliferation, specific antibody responses, and DTH reaction. To describe the durability of the immunogen in patients who respond to the first 7 injections when they are boosted every 8 weeks for an additional 6-12 months [AS PER AMENDMENT 11/12/96: stratum 1 patients only]. To describe the ability of the immunogen to induce a response after an additional 6-12 months of injections among patients who did not respond to the first 7 injections [AS PER AMENDMENT 11/12/96: stratum 1 patients only]. HIV-specific cellular immune responses appear to play an important role in HIV disease progression since both T helper and cytotoxic function against HIV decrease with disease progression.
NCT00000822 ↗	A Phase I/II Double-Blind Controlled Trial to Determine the Safety and Immunogenicity of HIV-1 MN rgp160 Immuno AG Vaccine Therapy in HIV-Infected Individuals With Greater Than or Equal to 500/mm3 CD4+ T Cells and 200-400/mm3 CD4+ T Cells	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To evaluate the safety and immunogenicity of HIV-1 MN rgp160 (Immuno-AG) in HIV-infected patients. To evaluate the immunogenicity of HIV-1 MN rgp160 immunogen by lymphocyte proliferation, specific antibody responses, and DTH reaction. To describe the durability of the immunogen in patients who respond to the first 7 injections when they are boosted every 8 weeks for an additional 6-12 months [AS PER AMENDMENT 11/12/96: stratum 1 patients only]. To describe the ability of the immunogen to induce a response after an additional 6-12 months of injections among patients who did not respond to the first 7 injections [AS PER AMENDMENT 11/12/96: stratum 1 patients only]. HIV-specific cellular immune responses appear to play an important role in HIV disease progression since both T helper and cytotoxic function against HIV decrease with disease progression.

Clinical Trial Conditions for Ritonavir

Condition Name

Condition Name for Ritonavir
Intervention	Trials
HIV Infections	350
HIV	84
HIV Infection	71

Condition MeSH

Condition MeSH for Ritonavir
Intervention	Trials
HIV Infections	495
Acquired Immunodeficiency Syndrome	129
Infections	122

Clinical Trial Locations for Ritonavir

Trials by Country

Trials by Country for Ritonavir
Location	Trials
Canada	214
Spain	210
Brazil	93
China	89
Mexico	79

Trials by US State

Trials by US State for Ritonavir
Location	Trials
California	226
New York	189
Florida	172
Texas	159
Illinois	142

Clinical Trial Progress for Ritonavir

Clinical Trial Phase

Clinical Trial Phase for Ritonavir
Clinical Trial Phase	Trials
Phase 4	196
Phase 3	199
Phase 2/Phase 3	36

Clinical Trial Status

Clinical Trial Status for Ritonavir
Clinical Trial Phase	Trials
Completed	721
Terminated	75
Recruiting	66

Clinical Trial Sponsors for Ritonavir

Sponsor Name

Sponsor Name for Ritonavir
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	112
Abbott	71
Boehringer Ingelheim	70

Sponsor Type

Sponsor Type for Ritonavir
Sponsor	Trials
Other	887
Industry	703
NIH	182

Ritonavir: Clinical Trials, Market Analysis, and Projections

Introduction to Ritonavir

Ritonavir is a potent HIV protease inhibitor that has been widely used in the treatment of HIV-1 infection, often in combination with other antiretroviral agents. Recently, its use has been expanded to include the treatment of COVID-19, particularly when combined with nirmatrelvir.

Clinical Trials: COVID-19 Treatment

Efficacy in Mild to Moderate COVID-19

A significant phase 2/3 clinical trial evaluated the efficacy of nirmatrelvir/ritonavir (NMV/r) in high-risk, unvaccinated, nonhospitalized adults with mild to moderate COVID-19. The study, conducted across 21 countries, involved 2113 patients randomized to receive either NMV/r or a placebo. The results showed that NMV/r significantly reduced the time to sustained alleviation and resolution of COVID-19 symptoms, as well as the number of COVID-19-related medical visits. Notably, no patients treated with NMV/r died through Week 24, compared to 15 deaths in the placebo group[1].

Postacute Sequelae of SARS-CoV-2 Infection (PASC)

A randomized clinical trial, known as the STOP-PASC trial, investigated the efficacy of NMV/r in treating postacute sequelae of SARS-CoV-2 infection (PASC) in adults. The trial involved 155 participants with PASC symptoms lasting three months or more. Although the 15-day course of NMV/r was generally safe, it did not demonstrate a significant benefit in improving PASC symptoms such as fatigue, brain fog, and body aches. This study highlights the need for further research into the treatment of PASC[4].

Mechanism of Action

Ritonavir works by inhibiting the HIV protease enzyme, which is essential for the maturation of the HIV virus. In the context of COVID-19, ritonavir is used in combination with nirmatrelvir to inhibit the CYP3A4 enzyme, thereby slowing the metabolism of nirmatrelvir and increasing its therapeutic levels in the body[3].

Market Analysis

Global Market Size and Forecast

The global ritonavir market is expected to grow at a compound annual growth rate (CAGR) of 3 to 5 percent from 2024 to 2031. The market size is projected to increase significantly, driven by the demand for ritonavir in both HIV and COVID-19 treatments. The market is segmented by application (adults and children), product form (tablets, oral solution, and oral powder), and geographical regions (North America, Europe, Asia-Pacific, South America, and the Middle East and Africa)[5].

Key Market Players

The ritonavir market is dominated by several key players, including AbbVie, Hikma Pharmaceuticals, Cipla, Mylan, Hetero, Aurobindo Pharma, and Amneal Pharmaceuticals. These companies play a crucial role in the production and distribution of ritonavir, contributing to the market's growth and stability[5].

Regional Analysis

The global ritonavir market is geographically diverse, with significant contributions from North America, Europe, and the Asia-Pacific region. These regions are expected to continue driving the market growth due to increasing awareness and demand for antiviral treatments[5].

Market Trends and Drivers

Increasing Demand for Antiviral Treatments

The COVID-19 pandemic has significantly increased the demand for antiviral treatments, including ritonavir. This increased demand is expected to continue, driving the market growth in the forecast period.

Advancements in Pharmaceutical Technology

Advancements in pharmaceutical technology, such as improved formulations and delivery systems, are enhancing the efficacy and safety of ritonavir. These advancements are likely to attract more patients and healthcare providers, further boosting the market.

Regulatory Approvals

Regulatory approvals, such as the conditional marketing authorization in Europe for the use of ritonavir in combination with nirmatrelvir for COVID-19 treatment, are crucial for market expansion. Such approvals validate the safety and efficacy of the drug, increasing its adoption rate[3].

Market Restraints and Challenges

Competition from Alternative Treatments

The ritonavir market faces competition from other antiviral drugs and treatments, which can impact its market share. The availability of alternative treatments may reduce the demand for ritonavir, especially if these alternatives offer better efficacy or safety profiles.

Patent Expirations

The expiration of patents for ritonavir could lead to the entry of generic versions, which might reduce the market share of branded products. This could be a significant challenge for the key market players.

Regulatory Hurdles

Stringent regulatory requirements and the need for continuous clinical trials to prove efficacy and safety can be time-consuming and costly. These regulatory hurdles can slow down the market growth and limit the availability of ritonavir in certain regions.

Technological Trends

Improved Formulations

Research is ongoing to develop improved formulations of ritonavir, such as more stable and bioavailable forms. These advancements could enhance patient compliance and treatment outcomes.

Combination Therapies

The use of ritonavir in combination with other antivirals, like nirmatrelvir, is a significant technological trend. These combination therapies have shown promising results in treating COVID-19 and other viral infections[1].

Consumer Behavior Analysis

Patient Awareness and Education

Patient awareness and education about the benefits and risks of ritonavir are crucial for its adoption. Healthcare providers play a vital role in educating patients, which can influence consumer behavior and market demand.

Cost and Accessibility

The cost and accessibility of ritonavir are significant factors influencing consumer behavior. Affordable pricing and widespread availability can increase the drug's adoption rate, especially in developing regions.

SWOT Analysis

Strengths

• Established Efficacy: Ritonavir has a well-established efficacy in treating HIV and COVID-19.
• Wide Distribution: It is widely available across various regions.
• Strong Market Players: The presence of strong market players ensures consistent supply and innovation.

Weaknesses

• Competition: The market faces competition from other antiviral drugs.
• Regulatory Challenges: Stringent regulatory requirements can be a barrier.
• Patent Expirations: The expiration of patents could lead to generic competition.

Opportunities

• Growing Demand: Increasing demand for antiviral treatments due to the COVID-19 pandemic.
• Technological Advancements: Opportunities for improved formulations and combination therapies.
• Expanding Indications: Potential for use in treating other viral infections.

Threats

• Alternative Treatments: Competition from new and alternative treatments.
• Regulatory Hurdles: Continuous need for regulatory approvals and clinical trials.
• Economic Factors: Economic downturns could affect market growth.

Key Takeaways

• Ritonavir, in combination with nirmatrelvir, has shown significant efficacy in treating mild to moderate COVID-19.
• The drug did not demonstrate a significant benefit in improving postacute sequelae of SARS-CoV-2 infection (PASC) symptoms.
• The global ritonavir market is expected to grow at a CAGR of 3 to 5 percent from 2024 to 2031.
• Key market players include AbbVie, Hikma Pharmaceuticals, and Cipla.
• The market faces challenges such as competition from alternative treatments and regulatory hurdles.

FAQs

What is the primary use of ritonavir?

Ritonavir is primarily used as an HIV protease inhibitor in combination with other antiretroviral agents for the treatment of HIV-1 infection. It is also used in combination with nirmatrelvir for the treatment of mild to moderate COVID-19[3].

How does ritonavir work in COVID-19 treatment?

In COVID-19 treatment, ritonavir is used to inhibit the CYP3A4 enzyme, which slows the metabolism of nirmatrelvir, thereby increasing its therapeutic levels in the body[3].

What are the key findings of the STOP-PASC trial?

The STOP-PASC trial found that a 15-day course of nirmatrelvir/ritonavir was generally safe but did not demonstrate a significant benefit in improving PASC symptoms in a mostly vaccinated cohort[4].

Which regions are expected to dominate the global ritonavir market?

North America, Europe, and the Asia-Pacific region are expected to dominate the global ritonavir market due to increasing awareness and demand for antiviral treatments[5].

What are the major challenges facing the ritonavir market?

The major challenges include competition from alternative treatments, patent expirations, and regulatory hurdles[5].

Sources

1. Nirmatrelvir/ritonavir (NMV/r) significantly reduced times to sustained alleviation and resolution and the number of coronavirus-related medical visits. Clinical Infectious Diseases, 2024.
2. Global Ritonavir Market Report 2024 Edition. Cognitivemarketresearch.com.
3. Ritonavir: Uses, Interactions, Mechanism of Action. DrugBank Online.
4. Nirmatrelvir-Ritonavir and Symptoms in Adults With Postacute Sequelae of SARS-CoV-2 Infection. JAMA Internal Medicine, 2024.
5. Global Ritonavir Market Size And Forcast. Market Research Intellect.