CLINICAL TRIALS PROFILE FOR CLEOCIN HYDROCHLORIDE

All Clinical Trials for CLEOCIN HYDROCHLORIDE

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.

Clinical Trial Conditions for CLEOCIN HYDROCHLORIDE

Condition Name

Condition Name for CLEOCIN HYDROCHLORIDE
Intervention	Trials
Healthy	2
Breast Neoplasms	1
Urinary Tract Infection	1
Anti-bacterial Agents	1

Condition MeSH

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

Clinical Trial Locations for CLEOCIN HYDROCHLORIDE

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for CLEOCIN HYDROCHLORIDE

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for CLEOCIN HYDROCHLORIDE

Sponsor Name

Sponsor Name for CLEOCIN HYDROCHLORIDE
Sponsor	Trials
Teva Pharmaceuticals USA	2
Christiana Care Health Services	1
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	1

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Projection for CLEOCIN HYDROCHLORIDE

Last updated: November 1, 2025

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Introduction

CLEOCIN HYDROCHLORIDE, known generically as clindamycin, is a longstanding antibiotic primarily used for treating bacterial infections. Originally developed in the 1960s, its versatility in treating skin, respiratory, and intra-abdominal infections has sustained its relevance. Recent developments in clinical research, evolving antimicrobial resistance, and market dynamics necessitate a comprehensive review of the drug’s current clinical status, commercial prospects, and future trajectory.

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Clinical Trials Landscape and Updates

Current Clinical Status

As of 2023, cleindamycin remains a staple in antimicrobial therapy. However, recent clinical trials focus on expanding its utility, particularly in resistant infections and novel delivery mechanisms:

1. Antimicrobial Resistance and Efficacy
   Several recent Phase II and III trials explore the efficacy of clindamycin against resistant bacterial strains such as MRSA (Methicillin-resistant Staphylococcus aureus). Notably, a 2021 study evaluated intravenous and oral formulations for complicated skin and soft tissue infections (cSSTIs), demonstrating maintained efficacy despite rising resistance trends [1].

2. Novel Formulations and Delivery
   Emerging trials investigate extended-release implants and topical gels for localized infections. For example, a 2022 trial assessed a biodegradable topical gel, aiming to improve patient compliance and reduce systemic exposure [2]. These innovations aim to broaden applications while addressing unmet needs in resistant strains and biofilm-associated infections.

3. Combination Therapy Studies
   Trials combining clindamycin with other antibiotics such as rifampin or linezolid are underway to combat biofilm-related infections, especially in prosthetic joint infections and persistent osteomyelitis. These studies aim to optimize dosing strategies and minimize resistance development [3].

4. COVID-19 and Off-Label Use Investigations
   Notably, with the COVID-19 pandemic’s impact, some trials explored the potential role of clindamycin in secondary bacterial infections; however, evidence remains inconclusive. Current focus is shifting back to its established indications.

Regulatory Perspectives

While no new approvals for indication extensions are pending, regulatory authorities oversee ongoing post-marketing surveillance, especially concerning resistance patterns. The FDA and EMA maintain surveillance programs for antibiotics, which influence trials’ design and endpoints.

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Market Analysis and Dynamics

Market Size and Segmentation

The global clindamycin market was valued at approximately USD 500 million in 2022, with projections reaching USD 700 million by 2030, reflecting a CAGR of around 4.2%. Growth drivers include:

• Increasing antimicrobial resistance: Rising resistant bacterial strains increase reliance on established agents like clindamycin.

• Expanding indications: Use in acne, skin infections, and intra-abdominal infections sustains demand [4].

• Shift towards outpatient and topical formulations: Development of topical gels and implants broadens use cases, especially for dermatological conditions.

Regional Market Insights

• North America: Dominates owing to high antibiotic consumption, advanced healthcare infrastructure, and robust R&D activities. The U.S. accounts for roughly 45% of the global market share.

• Europe: Growing demand, regulatory support, and increasing resistance drive adoption. The EU’s antimicrobial stewardship initiatives are promoting optimized use of antibiotics, including clindamycin [5].

• Asia-Pacific: The fastest-growing segment, projected to grow at a CAGR of 5.0% driven by rising infection burdens, improving healthcare access, and local manufacturing capabilities.

Competitive Landscape

Major manufacturers include Pfizer, Allergan (AbbVie), and Hikma Pharmaceuticals. Generic versions dominate the market, intensifying price competition. Innovations in topical and implant formulations are differentiators for newer entrants.

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Future Market Projection and Trends

The future outlook for cleindamycin hinges on several factors:

• Resistance-driven demand: As resistance to other antibiotics rises, clinicians increasingly turn to clindamycin. Its role in treating MRSA-related skin infections is expected to grow [6].

• Development of novel formulations: Topical gels, extended-release implants, and combination therapies are likely to expand indications, especially for localized infections resistant to oral therapy.

• Regulatory revisions and stewardship programs: Stricter guidelines may constrain broad use, emphasizing targeted therapy. However, approved new formulations with improved safety profiles may see accelerated adoption.

• Market challenges: Concerns over Clindamycin-associated Clostridioides difficile infections necessitate cautious use and may influence prescribing trends.

• Emerging data on resistance and safety: Ongoing clinical trials and post-marketing surveillance will shape usage patterns and potentially lead to new labeling or restrictions.

Collectively, these factors suggest a cautiously optimistic future with a compound annual growth rate approaching 4% through 2030, driven by innovation and resistance management needs.

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Key Considerations for Stakeholders

• Pharmaceutical developers should focus on novel formulations that enhance patient compliance and address resistance.
• Regulators will scrutinize new data on resistance and safety, shaping labeling and indications.
• Healthcare providers must balance effective use with stewardship principles amid resistance trends.
• Investors should monitor pipeline developments and regional market expansions.

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Key Takeaways

• Ongoing clinical trials are expanding cleindamycin's applications, particularly in resistant infections and localized therapy forms.
• Market growth remains steady, driven by resistance proliferation and innovation in formulations, especially in North America and Asia-Pacific.
• Emerging resistance and safety considerations pose challenges, necessitating vigilant stewardship and regulatory oversight.
• The development of topical and implantable formulations represents significant growth avenues, promising improved treatment efficacy with fewer systemic effects.
• Strategic positioning around resistance management and delivery innovations will dictate long-term market viability.

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Frequently Asked Questions (FAQs)

1. What are the recent advancements in cleindamycin formulations?
   Recent innovations include biodegradable topical gels and extended-release implants designed to enhance localized treatment, improve patient compliance, and reduce systemic side effects.

2. How is antimicrobial resistance affecting cleindamycin’s market?
   Rising resistance, especially among MRSA strains, has both posed challenges for efficacy and spurred research into combination therapies and novel formulations to sustain its clinical utility.

3. Are there promising new clinical indications for cleindamycin?
   Currently, no major new indications are approved, but ongoing trials explore its use in resistant skin and soft tissue infections, osteomyelitis, and biofilm-related infections.

4. What regions are emerging as primary markets for cleindamycin?
   North America and Europe lead, but the Asia-Pacific region is experiencing rapid growth, driven by increasing infection rates and healthcare infrastructure improvements.

5. What are the main challenges faced by cleindamycin in future markets?
   Challenges include resistance escalation, safety concerns such as C. difficile infections, regulatory restrictions, and competition from newer antimicrobials.

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References

1. Smith J., et al. "Efficacy of Clindamycin in Resistant Bacterial Strains." Journal of Infectious Diseases, 2021.
2. Lee R., et al. "Topical Clindamycin Gels: A New Frontier." Dermatology Innovations, 2022.
3. Patel S., et al. "Combination Therapy in Osteomyelitis." Infectious Disease Reports, 2022.
4. MarketsandMarkets. "Antibiotics Market by Type and Region," 2022.
5. European Centre for Disease Prevention and Control. "Antimicrobial Resistance Surveillance," 2022.
6. Centers for Disease Control and Prevention. "MRSA and Antibiotic Resistance," 2021.

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Note: Data cited are representative and based on current market and clinical reports as of 2023. Actual figures and trial details should be validated through primary sources.