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Last Updated: March 30, 2025

CLINICAL TRIALS PROFILE FOR CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE


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All Clinical Trials for CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00219570 ↗ Dalacin-T Gel Post Approval Study Completed Acronet Phase 4 2005-01-01 To investigate, in a comparison vs. Acuatim cream (nadifloxacin cream), the efficacy and safety of Dalacin T Gel (clindamycin phosphate gel) as a therapeutic medication for acne vulgaris in acne vulgaris patients, including children ages 13 and up, in order to clarify the clinical positioning of Dalacin T Gel.
NCT00160394 ↗ Comparison of Duac® Gel And Differin® Gel in Mild to Moderate Acne Vulgaris Completed GlaxoSmithKline Phase 4 2004-12-01 Comparing the efficacy and safety of a gel formulation containing a combination of clindamycin phosphate (equivalent to 1% clindamycin) and benzoyl peroxide (5%) once daily with a gel containing 0.1% adapalene once daily in the treatment of acne vulgaris of mild to moderate severity.
NCT00160394 ↗ Comparison of Duac® Gel And Differin® Gel in Mild to Moderate Acne Vulgaris Completed Stiefel, a GSK Company Phase 4 2004-12-01 Comparing the efficacy and safety of a gel formulation containing a combination of clindamycin phosphate (equivalent to 1% clindamycin) and benzoyl peroxide (5%) once daily with a gel containing 0.1% adapalene once daily in the treatment of acne vulgaris of mild to moderate severity.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 3 of 3 entries

Clinical Trial Conditions for CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE

Condition Name

18320024681012141618Acne VulgarisBACTERIAL VAGINOSISAcne[disabled in preview]
Condition Name for CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE
Intervention Trials
Acne Vulgaris 18
BACTERIAL VAGINOSIS 3
Acne 2
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Condition MeSH

20320-20246810121416182022Acne VulgarisVaginosis, BacterialVaginal Diseases[disabled in preview]
Condition MeSH for CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE
Intervention Trials
Acne Vulgaris 20
Vaginosis, Bacterial 3
Vaginal Diseases 2
[disabled in preview] 0
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Clinical Trial Locations for CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE

Trials by Country

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Trials by Country for CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE
Location Trials
United States 90
India 19
China 10
Russian Federation 4
Puerto Rico 2
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Trials by US State

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Trials by US State for CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE
Location Trials
Pennsylvania 6
New York 6
Texas 5
Florida 5
California 5
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Clinical Trial Progress for CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE

Clinical Trial Phase

50.0%45.0%5.0%0-101234567891011Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE
Clinical Trial Phase Trials
Phase 4 10
Phase 3 9
Phase 2/Phase 3 1
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Clinical Trial Status

83.3%13.3%00510152025CompletedUnknown statusRecruiting[disabled in preview]
Clinical Trial Status for CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE
Clinical Trial Phase Trials
Completed 25
Unknown status 4
Recruiting 1
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Clinical Trial Sponsors for CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE

Sponsor Name

trials01122334455667GlaxoSmithKlineStiefel, a GSK CompanyDaré Bioscience, Inc.[disabled in preview]
Sponsor Name for CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE
Sponsor Trials
GlaxoSmithKline 6
Stiefel, a GSK Company 4
Daré Bioscience, Inc. 2
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Sponsor Type

68.6%31.4%005101520253035IndustryOther[disabled in preview]
Sponsor Type for CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE
Sponsor Trials
Industry 35
Other 16
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Clindamycin Phosphate in 0.9% Sodium Chloride: Clinical Trials, Market Analysis, and Projections

Introduction

Clindamycin phosphate, a potent antibiotic, has been a cornerstone in the treatment of various bacterial infections since its approval in 1972. This article delves into the current state of clinical trials, market analysis, and future projections for clindamycin phosphate in 0.9% sodium chloride.

Mechanism of Action and Therapeutic Uses

Clindamycin phosphate is a small molecule drug that targets the 50S subunit of bacterial ribosomes, inhibiting protein synthesis and leading to the death or growth inhibition of bacteria. It is indicated for the treatment of serious infections caused by susceptible strains of streptococci, pneumococci, and staphylococci, including skin and skin structure infections, lower respiratory tract infections, gynecological infections, intra-abdominal infections, septicemia, and bone and joint infections[3][4].

Clinical Trials and Regulatory Status

Clindamycin phosphate has undergone extensive clinical trials and has been approved globally for various therapeutic uses. It holds a fast-track regulatory status due to its potential to address unmet medical needs. The drug has successfully completed all necessary regulatory requirements and is widely used in clinical practice[4].

Recent Studies and Feasibility

A recent study by the FDA evaluated the feasibility of using in vitro permeation testing (IVPT) for Cleocin T® lotion, which contains clindamycin phosphate. The study found that both clindamycin phosphate and its active metabolite, clindamycin base, permeate across the skin, suggesting that IVPT could be a viable method for assessing the bioequivalence of topical formulations[1].

Market Analysis

Global Market Size and Growth

The global clindamycin phosphate injection market was valued at USD 451.67 million in 2023 and is projected to grow to USD 743.86 million by 2032, exhibiting a compound annual growth rate (CAGR) of 5.7% during the forecast period. This growth is driven by the increasing incidence of bacterial infections, particularly in immunocompromised patients, and the rising prevalence of skin and soft tissue infections[5].

Regional Insights

North America currently holds the largest share of the global clindamycin phosphate injection market, attributed to its sophisticated healthcare system and high rate of bacterial infections. The Asia Pacific region is expected to witness substantial growth due to expanding healthcare infrastructure and rising infection rates in countries like China, India, and Southeast Asian nations[5].

Key Drivers

  • Rising Antibiotic Resistance: The increasing prevalence of antibiotic-resistant bacteria is driving demand for effective treatments like clindamycin phosphate.
  • Expansion in Emerging Markets: Growing healthcare infrastructure in emerging markets is fueling market growth.
  • Development of Combination Therapies: Research into combination therapies involving clindamycin phosphate is on the rise to enhance efficacy and combat complex infections.
  • Shift Towards Homecare Settings: The trend towards outpatient and homecare settings for administering antibiotics is growing, supported by advancements in portable infusion technology[5].

Market Trends

Adoption of Combination Therapies

There is a growing trend towards the adoption of clindamycin-based combination therapies to enhance efficacy and combat antibiotic-resistant infections. This approach is particularly relevant in treating complex infections where single-agent therapies may not be sufficient[2][5].

Focus on Antibiotic Stewardship

The rising focus on antibiotic stewardship to combat resistance is another significant trend. This involves the judicious use of antibiotics to minimize the development of resistant bacterial strains, ensuring the long-term effectiveness of drugs like clindamycin phosphate[2].

Personalized Dermatological Treatments

There is an increasing shift towards personalized dermatological treatments, which includes the use of clindamycin phosphate in tailored therapeutic regimens. This approach aims to optimize treatment outcomes based on individual patient needs and infection profiles[2].

Projections and Future Outlook

Market Growth Projections

The clindamycin phosphate injection market is expected to continue its growth trajectory, driven by the factors mentioned above. By 2032, the market is projected to reach USD 743.86 million, with a CAGR of 5.7% during the forecast period[5].

Emerging Markets

Emerging markets, particularly in the Asia Pacific region, are expected to play a significant role in the future growth of the clindamycin phosphate market. The expanding healthcare infrastructure and increasing awareness of skin health and hygiene in these regions will drive demand for effective topical and injectable antibiotics[2][5].

Research and Development

Continuous investment in research and development is crucial for addressing emerging antibiotic resistance issues. Companies are focusing on innovating and improving product formulations, as well as developing new combination therapies to stay ahead in the market[5].

Key Takeaways

  • Clindamycin phosphate is a widely used antibiotic with a broad spectrum of therapeutic applications.
  • The drug has undergone extensive clinical trials and holds a fast-track regulatory status.
  • The global clindamycin phosphate injection market is projected to grow significantly, driven by rising antibiotic resistance and expanding healthcare infrastructure in emerging markets.
  • Key trends include the adoption of combination therapies, focus on antibiotic stewardship, and a shift towards personalized dermatological treatments.
  • Emerging markets, particularly in the Asia Pacific region, are expected to drive future market growth.

FAQs

What is the primary mechanism of action of clindamycin phosphate?

Clindamycin phosphate targets the 50S subunit of bacterial ribosomes, inhibiting protein synthesis and leading to the death or growth inhibition of bacteria[4].

What are the main indications for clindamycin phosphate in 0.9% sodium chloride?

Clindamycin phosphate in 0.9% sodium chloride is indicated for the treatment of serious infections caused by susceptible strains of streptococci, pneumococci, and staphylococci, including skin and skin structure infections, lower respiratory tract infections, and others[3].

What is the projected growth rate of the global clindamycin phosphate injection market?

The global clindamycin phosphate injection market is projected to grow at a CAGR of 5.7% from 2023 to 2032[5].

Which region is expected to witness substantial growth in the clindamycin phosphate market?

The Asia Pacific region is expected to witness substantial growth due to expanding healthcare infrastructure and rising infection rates in countries like China, India, and Southeast Asian nations[5].

What are the key drivers of the clindamycin phosphate market growth?

Key drivers include the rising incidence of bacterial infections, expansion in emerging markets, development of combination therapies, and a shift towards homecare settings[5].

Sources

  1. FDA Science Forum: Feasibility of In Vitro Permeation Testing for Cleocin T - FDA.
  2. The Business Research Company: Clindamycin Phosphate Topical Global Market Report 2025.
  3. FDA Label: CLINDAMYCIN IN 0.9% SODIUM CHLORIDE - accessdata.fda.gov.
  4. Patsnap Synapse: Clindamycin Phosphate Unveiled: A Detailed Overview of its Revolutionary R&D Breakthroughs, Mechanisms of Action, and Drug Target.
  5. Polaris Market Research: Clindamycin Phosphate Injection Market Growth Report, 2032.

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