You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 28, 2025

CLINICAL TRIALS PROFILE FOR QUININE SULFATE


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for QUININE SULFATE

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00779259 ↗ Drug - Drug Interaction Study Between Quinine Sulfate and Theophylline Completed Mutual Pharmaceutical Company, Inc. Phase 1 2007-08-01 In a prior in vitro study using human hepatocytes quinine was shown to induce the activity of Cytochrome p450 CYP 1A2. The present study will evaluate the extent to which quinine sulfate-related induction of this enzyme effects the pharmacokinetics of theophylline, a sensitive probe drug for the activity of CYP 1A2. It will also evaluate the effect of single-dose theophylline on the pharmacokinetics of steady-state quinine sulfate.
NCT00726414 ↗ A Relative Bioavailability Study of Quinine Sulfate Capsules 324mg Completed Mutual Pharmaceutical Company, Inc. Phase 1 2005-12-01 The purpose of this study is to evaluate and compare the relative bioavailability of Quinine Sulfate capsules following a single, oral dose in healthy volunteers under fasting and fed conditions.
NCT00726895 ↗ A Dose Proportionality Study of Quinine Sulfate Capsules Under Fasting Conditions Completed Mutual Pharmaceutical Company, Inc. Phase 1 2004-05-01 The purpose of this study is to evaluate and compare the dose proportionality of 324 mg Quinine Sulfate capsules following a single oral dose (1 x 324 mg capsules versus 2 x 324 mg capsules) in healthy adult volunteers when administered under fasting conditions.
NCT00727272 ↗ A Relative Bioavailability Study of Quinine Sulfate Capsules Under Fasting and Fed Conditions Completed Mutual Pharmaceutical Company, Inc. Phase 1 2004-02-01 The purpose of this study is to evaluate and compare the relative bioavailability of Quinine Sulfate 324 mg capsules, manufactured by the Mutual Pharmaceutical Company, to Quinine Sulphate 300 mg tablets, manufactured by the Government Pharmaceutical Organization, Bangkok Metropolis, Thailand, after single oral dose administration under fasting conditions. An additional purpose of this study is to evaluate the effect of food on the Mutual Pharmaceutical Company product.
NCT00000706 ↗ Influence of Probenecid and Quinine on the Pharmacokinetics of Azidothymidine Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A 1969-12-31 Part I studies the effect of quinine on how zidovudine (AZT) is used by the body and eliminated through the kidneys in HIV infected patients. Part II studies the effect of probenecid and quinine on the same aspects. Because AZT leaves the bloodstream quickly, patients must take the drug frequently to keep adequate amounts in their bodies. Probenecid and quinine may slow down the rate at which AZT leaves the body. Therefore, taking these drugs along with AZT may reduce the amount of AZT needed for treatment.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 5 of 5 entries

Clinical Trial Conditions for QUININE SULFATE

Condition Name

82110012345678HealthyAmyotrophic Lateral SclerosisHemorrhoidsHemorrhoids, Internal[disabled in preview]
Condition Name for QUININE SULFATE
Intervention Trials
Healthy 8
Amyotrophic Lateral Sclerosis 2
Hemorrhoids 1
Hemorrhoids, Internal 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

22220-0.200.20.40.60.811.21.41.61.822.2Muscle CrampMotor Neuron DiseaseHemorrhoidsAmyotrophic Lateral Sclerosis[disabled in preview]
Condition MeSH for QUININE SULFATE
Intervention Trials
Muscle Cramp 2
Motor Neuron Disease 2
Hemorrhoids 2
Amyotrophic Lateral Sclerosis 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for QUININE SULFATE

Trials by Country

+
Trials by Country for QUININE SULFATE
Location Trials
United States 8
Portugal 2
Indonesia 2
Switzerland 1
Canada 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

+
Trials by US State for QUININE SULFATE
Location Trials
North Dakota 2
Maryland 1
New York 1
Pennsylvania 1
Florida 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for QUININE SULFATE

Clinical Trial Phase

5.9%5.9%11.8%76.5%002468101214Phase 2/Phase 3Phase 2Phase 1/Phase 2[disabled in preview]
Clinical Trial Phase for QUININE SULFATE
Clinical Trial Phase Trials
Phase 2/Phase 3 1
Phase 2 1
Phase 1/Phase 2 2
[disabled in preview] 13
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

76.5%11.8%5.9%5.9%002468101214CompletedTerminatedNot yet recruiting[disabled in preview]
Clinical Trial Status for QUININE SULFATE
Clinical Trial Phase Trials
Completed 13
Terminated 2
Not yet recruiting 1
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for QUININE SULFATE

Sponsor Name

trials0123456789Mutual Pharmaceutical Company, Inc.Universidade do PortoALS Association[disabled in preview]
Sponsor Name for QUININE SULFATE
Sponsor Trials
Mutual Pharmaceutical Company, Inc. 9
Universidade do Porto 2
ALS Association 1
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

45.5%45.5%012345678910OtherIndustryU.S. Fed[disabled in preview]
Sponsor Type for QUININE SULFATE
Sponsor Trials
Other 10
Industry 10
U.S. Fed 1
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Quinine Sulfate: Clinical Trials, Market Analysis, and Projections

Introduction to Quinine Sulfate

Quinine sulfate, derived from the bark of the cinchona tree, has been a cornerstone in the treatment of malaria for centuries. Its use extends beyond malaria, including applications in muscle relaxants and other therapeutic areas. Here, we delve into the current state of clinical trials, market analysis, and future projections for quinine sulfate.

Clinical Trials and Medical Uses

Malaria Treatment

Quinine sulfate is primarily used to treat uncomplicated Plasmodium falciparum malaria. It is the first and only formulation of quinine sulfate approved by the U.S. Food and Drug Administration (FDA) for this purpose, and it has been designated as an orphan drug[1].

Other Medical Uses

Apart from malaria, quinine sulfate has been used to treat nocturnal leg cramps, particularly in older patients. It works by decreasing the excitability of the motor end-plate and increasing the muscle refractory period[5].

Clinical Trials

Quinine has been investigated in various clinical trials beyond its traditional use. For example, it was studied for its efficacy in preventing SARS-CoV-2 infection, although the trial was terminated. It is also planned to be evaluated for preventing sinusitis after endoscopic sinus surgery[4].

Market Analysis

Current Market Size and Growth

The global quinine sulfate market has experienced significant growth, driven by factors such as increasing malaria prevalence, demand for anti-malarial treatments, and rising healthcare expenditure in developing nations. The market size was estimated to be $2.23 billion in 2023 and is projected to grow to $2.41 billion in 2024 at a compound annual growth rate (CAGR) of 8.3%[3].

Forecasted Growth

The market is anticipated to continue its robust growth, reaching $3.33 billion by 2028 at a CAGR of 8.4%. Key drivers include a heightened focus on treating tropical diseases, increased healthcare spending, rising demand for muscle relaxant medications, and a growing population in malaria-prone regions[3].

Regional and Application-Based Segmentation

The quinine sulfate market is segmented based on geography and application. The primary applications include:

  • Malaria: The most significant use, driven by the need for effective anti-malarial treatments.
  • Problematic Leg Cramps: Quinine sulfate is widely used to treat nocturnal leg cramps, especially in older patients.
  • Other Applications: Including its use in tonic water and as a chiral moiety in various chemical reactions[5].

Market Drivers and Trends

Increasing Demand for Anti-Malarial Treatments

The rise in malaria cases, particularly in tropical regions, has significantly driven the demand for quinine sulfate. This trend is expected to continue as global efforts to eradicate malaria intensify[3].

Growing Interest in Natural and Organic Products

The increasing interest in natural and organic products is another key driver. Quinine sulfate, being a plant-based alternative, aligns with consumer preferences for traditional herbal remedies and natural ingredients[2].

Technological Integration and Regulatory Emphasis

Technological advancements in pharmaceutical production and a growing regulatory emphasis on drug safety are also contributing to the market's growth. These factors ensure higher quality and safer products, which in turn boost consumer confidence and market demand[2].

Healthcare Expenditure in Developing Nations

Increased healthcare spending in developing countries is a significant factor, as these regions often have the highest incidence of malaria and other tropical diseases. This increased expenditure supports the expansion of the quinine sulfate market[3].

Key Players in the Market

The global quinine sulfate market is competitive, with several key players:

  • Actavis
  • Wockhardt
  • Shreeji Pharma International
  • A. B. Enterprises
  • Caraco Pharmaceutical Laboratories
  • Aecochem Corp
  • Hangzhou Dayang Co. Ltd.
  • Haihang Industry Co. Ltd.
  • Trademax Pharmaceuticals & Chemicals
  • IS Chemical Technology Ltd.[5].

These companies are involved in various strategies such as market share expansion, product innovation, and strategic partnerships to maintain their competitive edge.

Adverse Effects and Safety Considerations

Quinine sulfate is associated with several adverse effects, including a cluster of symptoms known as "cinchonism." Mild cinchonism symptoms include headache, sweating, ringing in the ears, dizziness, and nausea. More severe side effects can occur, and the drug is contraindicated in patients with certain conditions such as prolonged QT interval, G6-PD deficiency, and known hypersensitivity to quinine[1].

Conclusion

Quinine sulfate remains a vital medication in the fight against malaria and other conditions. The market for quinine sulfate is poised for significant growth, driven by increasing demand for anti-malarial treatments, growing healthcare expenditure, and a rising interest in natural and organic products.

Key Takeaways

  • Clinical Trials: Quinine sulfate is being explored for new uses beyond malaria treatment.
  • Market Growth: The market is expected to grow from $2.23 billion in 2023 to $3.33 billion by 2028.
  • Drivers: Increasing malaria prevalence, demand for anti-malarial treatments, and growing healthcare expenditure in developing nations.
  • Key Players: Several major pharmaceutical companies are active in the market.
  • Safety Considerations: Quinine sulfate has associated adverse effects and contraindications that must be carefully managed.

FAQs

What is the primary use of quinine sulfate?

Quinine sulfate is primarily used to treat uncomplicated Plasmodium falciparum malaria.

What are the common adverse effects of quinine sulfate?

Common adverse effects include symptoms of cinchonism such as headache, sweating, ringing in the ears, dizziness, and nausea.

Which companies are key players in the quinine sulfate market?

Key players include Actavis, Wockhardt, Shreeji Pharma International, and several others.

What is the projected growth rate of the quinine sulfate market?

The market is expected to grow at a CAGR of 8.4% from 2023 to 2028.

Is quinine sulfate used for any other medical conditions besides malaria?

Yes, it is also used to treat nocturnal leg cramps, particularly in older patients.

Sources

  1. Mutual Pharmaceutical Company/AR Scientific Launches QUALAQUIN(TM) (Quinine Sulfate Capsules USP, 324 mg) - PR Newswire.
  2. Quinine Sulfate Market Size, Regional Overview, Competitive Landscape, Business Growth, Share Analysis And Forecast To 2033 - The Business Research Company.
  3. Comprehensive Study On The Global Quinine Sulfate Market Trends And Market Opportunities 2024-2033 - EIN Presswire.
  4. Quinine: Uses, Interactions, Mechanism of Action | DrugBank Online - DrugBank.
  5. Quinine Sulphate Market Size, Share, Opportunities & Forecast - Verified Market Research.

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.