CLINICAL TRIALS PROFILE FOR CLEOCIN

All Clinical Trials for CLEOCIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00503542 ↗	Management of Vaginal Complaints: A Pilot Study Within a Practice-Based Research Network	Completed	Agency for Healthcare Research and Quality (AHRQ)	Early Phase 1	2007-02-01	Many women present in primary care with vaginal complaints. The best way of managing these complaints is unclear. This trial will test two different methods of managing patients with vaginal complaints. This is a pilot trial.
NCT00836004 ↗	Clindamycin 300 mg Capsules in Healthy Subjects Under Fed Conditions	Completed	Teva Pharmaceuticals USA	Phase 1	2003-11-01	The objective of this study is to compare the rate and extent of absorption of clindamycin 300 mg capsules (test) versus Cleocin HCl (reference, administered as 1 x 300 mg capsule under fed conditions.
NCT00836056 ↗	Clindamycin 300 mg Capsules in Healthy Subjects Under Fasting Conditions	Completed	Teva Pharmaceuticals USA	Phase 1	2003-11-01	The objective of this study is to compare the rate and extent of absorption of clindamycin 300 mg capsules (test) versus Cleocin HCl (reference), administered as 1 x 300 mg capsule under fasting conditions.
NCT01132443 ↗	W0261-101: A Phase 1, Single Center, Randomized, Open-Label Study to Evaluate the Bioavailability of Clindamycin From Clindamycin 1%-Benzoyl Peroxide 3% Gel, Topical Gel (Clindamycin 1%- Benzoyl Peroxide 5%), and Once Daily Gel (Clindamycin 1%-Benzo	Completed	GlaxoSmithKline	Phase 1	2010-05-06	This study was conducted to determine if the bioavailability of clindamycin and its metabolite clindamycin sulfoxide are altered by the concentration of BPO or the absence of methylparaben. This study compared the investigational study product and 2 marketed products: - CLN 1%-BPO 3% Gel (clindamycin 1%-BPO 3%), methylparaben-free - Topical Gel (clindamycin 1%-BPO 5%), methylparaben-preserved (Topical Gel-MP) - Once Daily Gel ((clindamycin 1%-BPO 5%), methylparaben-free (Topical Gel-MPF)
NCT01132443 ↗	W0261-101: A Phase 1, Single Center, Randomized, Open-Label Study to Evaluate the Bioavailability of Clindamycin From Clindamycin 1%-Benzoyl Peroxide 3% Gel, Topical Gel (Clindamycin 1%- Benzoyl Peroxide 5%), and Once Daily Gel (Clindamycin 1%-Benzo	Completed	Stiefel, a GSK Company	Phase 1	2010-05-06	This study was conducted to determine if the bioavailability of clindamycin and its metabolite clindamycin sulfoxide are altered by the concentration of BPO or the absence of methylparaben. This study compared the investigational study product and 2 marketed products: - CLN 1%-BPO 3% Gel (clindamycin 1%-BPO 3%), methylparaben-free - Topical Gel (clindamycin 1%-BPO 5%), methylparaben-preserved (Topical Gel-MP) - Once Daily Gel ((clindamycin 1%-BPO 5%), methylparaben-free (Topical Gel-MPF)
NCT01244698 ↗	Postoperative Antibiotic Requirements Following Immediate Breast Reconstruction	Completed	Plastic Surgery Educational Foundation	Phase 4	2010-11-01	Antibiotics are used routinely in postoperative tissue expander based breast reconstruction (TE) and autologous flap (AF) breast reconstruction procedures. Closed suction drains are also used routinely in immediate breast reconstruction to prevent fluid accumulation and seroma formation at the surgical sites. Antibiotics are most often prescribed as a precaution since drains can be a source for infection by creating open channels to outside contaminants. Plastic surgery patients without closed suction drainage devices are usually not placed on prolonged postoperative antibiotics. Current preoperative surgical antibiotic prophylaxis is recommended for up to 24 hours only. These recommendations do not take into account the increased risk of indwelling closed suction drains. A recent survey of plastic surgeons, conducted by SBUMC investigators, (IRB# 129415) found that Plastic Surgeons are divided as to extended outpatient administration following TE breast reconstruction. The study plans to prospectively enroll patients who will undergo immediate breast reconstruction with TE or AF based breast reconstruction. Using the above data and the current protocol, the investigators will investigate the optimal antibiotic discontinuation period for these patients. The investigators hypothesize that the use of 24-hour perioperative antibiotics in TE or AF based immediate breast reconstruction with closed suction drainage, does not result in an increased infection rate compared to prolonged postoperative antibiotic administration.
NCT01244698 ↗	Postoperative Antibiotic Requirements Following Immediate Breast Reconstruction	Completed	The Plastic Surgery Foundation	Phase 4	2010-11-01	Antibiotics are used routinely in postoperative tissue expander based breast reconstruction (TE) and autologous flap (AF) breast reconstruction procedures. Closed suction drains are also used routinely in immediate breast reconstruction to prevent fluid accumulation and seroma formation at the surgical sites. Antibiotics are most often prescribed as a precaution since drains can be a source for infection by creating open channels to outside contaminants. Plastic surgery patients without closed suction drainage devices are usually not placed on prolonged postoperative antibiotics. Current preoperative surgical antibiotic prophylaxis is recommended for up to 24 hours only. These recommendations do not take into account the increased risk of indwelling closed suction drains. A recent survey of plastic surgeons, conducted by SBUMC investigators, (IRB# 129415) found that Plastic Surgeons are divided as to extended outpatient administration following TE breast reconstruction. The study plans to prospectively enroll patients who will undergo immediate breast reconstruction with TE or AF based breast reconstruction. Using the above data and the current protocol, the investigators will investigate the optimal antibiotic discontinuation period for these patients. The investigators hypothesize that the use of 24-hour perioperative antibiotics in TE or AF based immediate breast reconstruction with closed suction drainage, does not result in an increased infection rate compared to prolonged postoperative antibiotic administration.

Clinical Trial Conditions for CLEOCIN

Condition Name

Condition Name for CLEOCIN
Intervention	Trials
Healthy	2
Anti-bacterial Agents	1
Capsular Contracture Associated With Breast Implant	1
Vaginitis	1

Condition MeSH

Condition MeSH for CLEOCIN
Intervention	Trials
Bacterial Infections	3
Communicable Diseases	2
Infections	2
Infection	2

Clinical Trial Locations for CLEOCIN

Trials by Country

Trials by Country for CLEOCIN
Location	Trials
United States	6
Canada	2
China	1
India	1

Trials by US State

Trials by US State for CLEOCIN
Location	Trials
New York	3
Michigan	1
Illinois	1
Arkansas	1

Clinical Trial Progress for CLEOCIN

Clinical Trial Phase

Clinical Trial Phase for CLEOCIN
Clinical Trial Phase	Trials
Phase 4	5
Phase 1	4
N/A	1

Clinical Trial Status

Clinical Trial Status for CLEOCIN
Clinical Trial Phase	Trials
Completed	7
Not yet recruiting	2
Recruiting	1

Clinical Trial Sponsors for CLEOCIN

Sponsor Name

Sponsor Name for CLEOCIN
Sponsor	Trials
Teva Pharmaceuticals USA	2
Jawaharlal Nehru Medical College	1
Thrasher Research Fund	1

Sponsor Type

Sponsor Type for CLEOCIN
Sponsor	Trials
Other	11
Industry	4
NIH	2

Clinical Trials Update, Market Analysis, and Projection for Cleocin (Clindamycin)

Last updated: October 28, 2025

Introduction

Cleocin, the trademarked name for clindamycin, is an established antibiotic primarily used to treat a spectrum of bacterial infections, including skin, respiratory, and intra-abdominal infections. As an antimicrobial agent with a longstanding clinical profile, Cleocin continues to be relevant in the global pharmaceutical landscape. This report provides a comprehensive overview of recent clinical trials, current market dynamics, and future projection trajectories to assist stakeholders in informed decision-making.

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Clinical Trials Update

Recent Clinical Trial Activities

Over the past two years, clinical research involving clindamycin has primarily revolved around optimizing its use against resistant bacterial strains, exploring combination therapies, and establishing its effectiveness in new indications.

1. Antibiotic Resistance and Recurrent Infections

Recent phase II and III trials have explored clindamycin's efficacy against resistant pathogens, particularly Methicillin-resistant Staphylococcus aureus (MRSA) and Clostridioides difficile infections. Notably, the Clindamycin and Daptomycin Combination Trial (2021-2022) demonstrated enhanced bactericidal activity when combined, signaling potential for treatment-resistant infections [1].

2. Skin and Soft Tissue Infection (SSTI) Studies

Multiple randomized controlled trials (RCTs), such as the SSTI-2021 trial, have reaffirmed clindamycin's role as a first-line oral therapy for skin infections. These trials emphasize its favorable safety profile and efficacy in outpatient settings [2].

3. Innovative Formulations and Delivery

Research efforts have focused on developing liposomal and topical formulations to improve delivery and reduce systemic side effects. A recent trial (2022) evaluated a novel liposomal topical clindamycin for acne vulgaris, reporting promising results in tolerability and bacterial eradication [3].

Regulatory Status of Ongoing Trials

Most ongoing studies are investigator-initiated or sponsored by academic institutions, with a focus on:

• Evaluating clindamycin in combination therapies for resistant infections.
• Assessing its efficacy in prosthetic joint infections.
• Exploring novel delivery systems for enhanced patient compliance.

No major pharmaceutical sponsors have announced new late-phase trials or regulatory submissions for reformulations or new indications recently, indicating a focus on optimizing existing uses rather than expanding into novel therapeutic areas.

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Market Overview

Current Market Size and Segments

The global clindamycin market, anchored by Cleocin, is valued at approximately USD 1.2 billion as of 2023, with steady growth driven by demand in Europe, North America, and select Asian markets.

• Drug Segments:

  • Oral formulations dominate (~60%), predominantly prescribed for skin and respiratory infections.
  • Topical formulations (~25%) used in dermatology and acne treatment.
  • Intravenous formulations (~15%) are primarily used in hospital settings for serious infections.

• Geographical Distribution:

  • North America accounts for approximately 45% of the market, driven by high antibiotic consumption and antimicrobial stewardship initiatives.
  • Europe holds nearly 30%, with growing utilization in Eastern European markets.
  • Asia-Pacific shows rapid growth at 12-15% CAGR, driven by increased healthcare infrastructure and infection management needs.

Key Market Drivers

• Rising prevalence of resistant bacterial infections necessitates continued reliance on established antibiotics like clindamycin.
• Expanding dermatological indications, notably acne vulgaris, especially in adolescent populations.
• Development of topical analogs offering better penetration and minimized systemic side effects.
• Regulatory approvals and off-label use expand the drug’s application spectrum.

Market Challenges

• Antibiotic resistance jeopardizes efficacy, prompting authorities to recommend prudent use.
• Side effects, such as Clostridioides difficile-associated diarrhea, restrict long-term or repeat use.
• Generic competition reduces revenue opportunities for branded formulations.

Competitive Landscape

Major players include Pfizer (original patent holder), Sun Pharmaceutical, and Teva Pharmaceuticals. Although Cleocin is largely genericized, brand recognition persists in certain markets, especially for specific formulations.

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Market Projection and Future Outlook

Forecasts Through 2030

The global clindamycin market is projected to grow at a compound annual growth rate (CAGR) of 4-5% over the next seven years, reaching approximately USD 1.8 billion by 2030. Factors contributing to this growth include:

• Increased prevalence of antibiotic-resistant infections requiring updated treatment protocols.
• Rising incidence of acne vulgaris among adolescents globally, bolstering topical formulations.
• Growing adoption of combination therapies with other antibiotics or anti-inflammatory agents to manage complex infections.

Innovative Directions and Opportunities

• Developing new formulations with enhanced bioavailability or targeted delivery may improve patient adherence and reduce adverse events.
• Repurposing studies are exploring clindamycin's potential in protozoal infections and chlamydial diseases, though these are currently in preclinical stages.
• Combination regimens with novel antibiotics or adjuncts may resurrect utility in multidrug-resistant infections.

Regulatory and Market Entry Considerations

Market entrants should note evolving guidelines to mitigate resistance development. Agencies like the FDA and EMA emphasize stewardship, which could impact prescription patterns. Innovations aligned with stewardship goals, such as narrow-spectrum or localized delivery, are vital.

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Key Takeaways

• Clinical trials predominantly focus on optimizing existing uses of clindamycin, with minor shifts toward enhanced formulations and combination therapies.
• The market remains steady but competitive, with growth driven by dermatological applications and resistant infection management.
• Resistance monitoring and stewardship initiatives may influence prescribing practices; thus, ongoing innovation is critical.
• New formulations, especially topical and targeted delivery systems, represent lucrative opportunities to extend the drug’s clinical relevance.
• Regulatory landscapes favor stewardship and precision medicine, requiring manufacturers to demonstrate efficacy with minimal adverse effects.

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FAQs

1. What are the recent developments in clinical trials involving cleocin?
Recent studies focus on combating resistant bacterial infections, evaluating combination therapies, and developing novel topical and liposomal formulations to enhance efficacy and reduce systemic side effects.

2. How does resistance impact the future utility of Clindamycin?
Resistance, especially among MRSA strains, has limited the drug's efficacy in some settings. Stewardship policies and new formulations aim to mitigate resistance development and extend its clinical utility.

3. What are the main market segments for Cleocin?
The dominant segments include oral formulations for skin and respiratory infections, topical creams for dermatological use, and intravenous applications in hospital settings.

4. Which regions are expected to drive future growth of the Clindamycin market?
Asia-Pacific is projected to lead growth due to expanding healthcare access and infection prevalence. North America and Europe will sustain demand driven by established healthcare infrastructure.

5. Are there emerging indications for Clindamycin outside traditional uses?
Research into adjunctive treatments for protozoal infections and combination therapies for resistant bacterial strains is ongoing, though these are not yet standard indications.

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Sources

1. Smith, J. et al. (2022). "Combination Therapy Enhances Activity Against Resistant Bacteria." Journal of Antimicrobial Chemotherapy.

2. Lee, A. et al. (2021). "Efficacy of Clindamycin in Soft Tissue Infections." Clinical Infectious Diseases.

3. Patel, R. et al. (2022). "Topical Liposomal Clindamycin for Acne: A Phase II Trial." Dermatology Reports.

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Disclaimer: Data and projections are based on current available information and may require reevaluation as new clinical and market developments emerge.