CLINICAL TRIALS PROFILE FOR CLINDAMYCIN HYDROCHLORIDE

505(b)(2) Clinical Trials for clindamycin hydrochloride

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 Dosage	NCT02058628 ↗	Comparison of the Efficacy and Safety of Clindamycin + Benzoyl Peroxide Formulation With Azelaic Acid Formulation in the Treatment of Acne Vulgaris	Completed	GlaxoSmithKline	Phase 4	2014-02-21	This is a randomized, comparator-controlled, single-blind, parallel-group study. The current study proposes to compare a fixed-dose combination product containing 3% benzoyl peroxide (BPO) and 1% clindamycin against a cream containing 20% azelaic acid for the treatment of facial acne vulgaris. The results of the study will enable a better assessment of the safety and efficacy of the new dose regime (BPO 3% + clindamycin 1%) in comparison to a well established treatment. Based on the data more evidence based recommendations will be possible to improve the treatment of subjects with acne vulgaris. A total of 220 subjects will be enrolled and will have 5 study visits (Day 1, Weeks 2, 4, 8 and 12). The duration of the study will be over 12 weeks.
New Formulation	NCT03615768 ↗	A Study to Evaluate the Efficacy and Safety of Adapalene-Clindamycin Combination Gel in the Treatment of Acne Vulgaris	Completed	Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Limited	Phase 3	2018-08-14	This is a study to see if Adapalene-Clindamycin Combination Gel is effective and safe in the treatment of acne vulgaris, compared to adapalene gel alone and clindamycin gel alone. Adapalene and clindamycin have been reported to have a better effect in acne treatment when used together. This new formulation is also easier to use as it combines two products into a single gel and only needs to be used once a day.
New Formulation	NCT03615768 ↗	A Study to Evaluate the Efficacy and Safety of Adapalene-Clindamycin Combination Gel in the Treatment of Acne Vulgaris	Completed	Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.	Phase 3	2018-08-14	This is a study to see if Adapalene-Clindamycin Combination Gel is effective and safe in the treatment of acne vulgaris, compared to adapalene gel alone and clindamycin gel alone. Adapalene and clindamycin have been reported to have a better effect in acne treatment when used together. This new formulation is also easier to use as it combines two products into a single gel and only needs to be used once a day.
New Formulation	NCT03615768 ↗	A Study to Evaluate the Efficacy and Safety of Adapalene-Clindamycin Combination Gel in the Treatment of Acne Vulgaris	Completed	Lee's Pharmaceutical Limited	Phase 3	2018-08-14	This is a study to see if Adapalene-Clindamycin Combination Gel is effective and safe in the treatment of acne vulgaris, compared to adapalene gel alone and clindamycin gel alone. Adapalene and clindamycin have been reported to have a better effect in acne treatment when used together. This new formulation is also easier to use as it combines two products into a single gel and only needs to be used once a day.

All Clinical Trials for clindamycin hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000640 ↗	A Phase III Comparative Study of Dapsone / Trimethoprim and Clindamycin / Primaquine Versus Sulfamethoxazole / Trimethoprim in the Treatment of Mild-to-Moderate PCP in Patients With AIDS	Completed	Glaxo Wellcome	Phase 3	1969-12-31	To evaluate the effectiveness of two oral treatments for mild to moderate Pneumocystis carinii pneumonia (PCP): dapsone/trimethoprim or clindamycin/primaquine as compared to a standard treatment program of sulfamethoxazole/trimethoprim (SMX/TMP) to assess the tolerance of these two alternative treatments as compared to the standard treatment of SMX/TMP. Per 09/09/92 amendment, to assess the efficacy and tolerance of these two alternative treatments in patients who are intolerant to SMX/TMP. The type of treatment being studied has the advantages of wide applicability throughout the world (including developing countries) and low cost. An oral treatment is more accessible to patients than drugs given by injection or by inhalation.
NCT00000640 ↗	A Phase III Comparative Study of Dapsone / Trimethoprim and Clindamycin / Primaquine Versus Sulfamethoxazole / Trimethoprim in the Treatment of Mild-to-Moderate PCP in Patients With AIDS	Completed	Jacobus Pharmaceutical	Phase 3	1969-12-31	To evaluate the effectiveness of two oral treatments for mild to moderate Pneumocystis carinii pneumonia (PCP): dapsone/trimethoprim or clindamycin/primaquine as compared to a standard treatment program of sulfamethoxazole/trimethoprim (SMX/TMP) to assess the tolerance of these two alternative treatments as compared to the standard treatment of SMX/TMP. Per 09/09/92 amendment, to assess the efficacy and tolerance of these two alternative treatments in patients who are intolerant to SMX/TMP. The type of treatment being studied has the advantages of wide applicability throughout the world (including developing countries) and low cost. An oral treatment is more accessible to patients than drugs given by injection or by inhalation.
NCT00000640 ↗	A Phase III Comparative Study of Dapsone / Trimethoprim and Clindamycin / Primaquine Versus Sulfamethoxazole / Trimethoprim in the Treatment of Mild-to-Moderate PCP in Patients With AIDS	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	To evaluate the effectiveness of two oral treatments for mild to moderate Pneumocystis carinii pneumonia (PCP): dapsone/trimethoprim or clindamycin/primaquine as compared to a standard treatment program of sulfamethoxazole/trimethoprim (SMX/TMP) to assess the tolerance of these two alternative treatments as compared to the standard treatment of SMX/TMP. Per 09/09/92 amendment, to assess the efficacy and tolerance of these two alternative treatments in patients who are intolerant to SMX/TMP. The type of treatment being studied has the advantages of wide applicability throughout the world (including developing countries) and low cost. An oral treatment is more accessible to patients than drugs given by injection or by inhalation.
NCT00000666 ↗	A Randomized Prospective Study of Pyrimethamine Therapy for Prevention of Toxoplasmic Encephalitis in HIV-Infected Individuals With Serologic Evidence of Latent Toxoplasma Gondii Infection	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To evaluate pyrimethamine as a prophylactic agent against toxoplasmic encephalitis in individuals who are coinfected with HIV and latent Toxoplasma gondii. Toxoplasmic encephalitis is a major cause of illness and death in AIDS patients. Standard treatment for toxoplasmic encephalitis is to combine pyrimethamine and sulfadiazine. Continuous treatment is necessary to prevent recurrence of the disease, but constant use of pyrimethamine/sulfadiazine is associated with toxicity. Clindamycin has been shown to be effective in treatment of toxoplasmic encephalitis in animal studies. This study evaluates pyrimethamine as a preventive treatment against toxoplasmic encephalitis (per 3/26/91 amendment, clindamycin arm was discontinued).
NCT00000674 ↗	A Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS	Completed	Glaxo Wellcome	N/A	1969-12-31	To collect information on the effectiveness and toxicity of clindamycin plus pyrimethamine and leucovorin calcium for the treatment of acute toxoplasmic encephalitis in adult patients with AIDS. Toxoplasmic encephalitis (encephalitis caused by Toxoplasma gondii) is the most frequent cause of focal central nervous system infection in patients with AIDS. If untreated, the encephalitis is fatal. At present, it is standard practice to give a combination of pyrimethamine and sulfadiazine to treat toxoplasmic encephalitis. The high frequency of sulfonamide-induced toxicity in AIDS patients often makes completion of a full course of therapy difficult. There is some information that high doses of parenteral (such as by injection) clindamycin used with pyrimethamine may be as effective as pyrimethamine plus sulfadiazine in the management of the acute phase of toxoplasmic encephalitis in patients with AIDS. Administration of parenteral clindamycin for prolonged periods of time, however, is costly, requires hospitalization, and is inconvenient for the patient. There is some indication that treatment of AIDS patients with acute toxoplasmic encephalitis with oral clindamycin may be effective. Leucovorin calcium is useful in preventing pyrimethamine-associated bone marrow toxicity.
NCT00000674 ↗	A Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS	Completed	Upjohn	N/A	1969-12-31	To collect information on the effectiveness and toxicity of clindamycin plus pyrimethamine and leucovorin calcium for the treatment of acute toxoplasmic encephalitis in adult patients with AIDS. Toxoplasmic encephalitis (encephalitis caused by Toxoplasma gondii) is the most frequent cause of focal central nervous system infection in patients with AIDS. If untreated, the encephalitis is fatal. At present, it is standard practice to give a combination of pyrimethamine and sulfadiazine to treat toxoplasmic encephalitis. The high frequency of sulfonamide-induced toxicity in AIDS patients often makes completion of a full course of therapy difficult. There is some information that high doses of parenteral (such as by injection) clindamycin used with pyrimethamine may be as effective as pyrimethamine plus sulfadiazine in the management of the acute phase of toxoplasmic encephalitis in patients with AIDS. Administration of parenteral clindamycin for prolonged periods of time, however, is costly, requires hospitalization, and is inconvenient for the patient. There is some indication that treatment of AIDS patients with acute toxoplasmic encephalitis with oral clindamycin may be effective. Leucovorin calcium is useful in preventing pyrimethamine-associated bone marrow toxicity.

Clinical Trial Conditions for clindamycin hydrochloride

Condition Name

Condition Name for clindamycin hydrochloride
Intervention	Trials
Acne Vulgaris	55
Malaria	10
Bacterial Vaginosis	10
Surgical Site Infection	6

Condition MeSH

Condition MeSH for clindamycin hydrochloride
Intervention	Trials
Acne Vulgaris	59
Infections	36
Infection	32
Communicable Diseases	30

Clinical Trial Locations for clindamycin hydrochloride

Trials by Country

Trials by Country for clindamycin hydrochloride
Location	Trials
United States	346
Canada	27
India	25
Germany	15
China	13

Trials by US State

Trials by US State for clindamycin hydrochloride
Location	Trials
California	30
New York	23
Pennsylvania	18
Texas	18
Florida	17

Clinical Trial Progress for clindamycin hydrochloride

Clinical Trial Phase

Clinical Trial Phase for clindamycin hydrochloride
Clinical Trial Phase	Trials
PHASE4	6
PHASE3	1
PHASE1	2

Clinical Trial Status

Clinical Trial Status for clindamycin hydrochloride
Clinical Trial Phase	Trials
Completed	136
Recruiting	33
Unknown status	32

Clinical Trial Sponsors for clindamycin hydrochloride

Sponsor Name

Sponsor Name for clindamycin hydrochloride
Sponsor	Trials
GlaxoSmithKline	23
Stiefel, a GSK Company	14
National Institute of Allergy and Infectious Diseases (NIAID)	7

Sponsor Type

Sponsor Type for clindamycin hydrochloride
Sponsor	Trials
Other	347
Industry	129
NIH	12

Clindamycin Hydrochloride: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

Introduction

Clindamycin Hydrochloride is a well-established antibiotic primarily employed in combating bacterial infections. Its mechanism involves inhibiting protein synthesis by binding to the 50S ribosomal subunit, rendering it effective against a broad spectrum of anaerobic bacteria and some protozoa. Despite its longstanding clinical utility, recent developments, including novel formulations and targeted applications, alongside evolving antimicrobial resistance (AMR), are shaping its market landscape. This analysis synthesizes current clinical trial data, examines market dynamics, and projects future trends for Clindamycin Hydrochloride.

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Clinical Trials Landscape for Clindamycin Hydrochloride

Current Status of Clinical Trials

The clinical research activity surrounding Clindamycin Hydrochloride has primarily focused on optimizing its delivery, combating resistance, and expanding its therapeutic indications.

• Formulation Innovation: A significant number of ongoing trials explore new formulations, including topical gels, vaginal films, and long-acting injectables. These efforts aim to improve patient compliance, reduce dosing frequency, and minimize adverse effects.

• Synergistic Therapeutics: Trials evaluate combinatory therapies, pairing Clindamycin with other antimicrobials or anti-inflammatory agents to enhance efficacy against resistant strains, especially in dermatological and gynecological infections.

• Resistance and Stewardship: Several ongoing studies assess the prevalence of Clindamycin-resistant bacteria and test stewardship protocols to optimize its utilization and mitigate resistance development. For instance, the CDC and other agencies sponsor trials examining resistance mechanisms, including MLS_B phenotype resistance.

Key Clinical Trial Outcomes

While large-scale Phase III trials specifically targeting new indications are limited, existing data confirm Clindamycin Hydrochloride’s efficacy and safety in the treatment of:

• Skin and Soft Tissue Infections (SSTIs): Trials demonstrate favorable outcomes in abscesses, cellulitis, and furunculosis, with comparable efficacy to other antibiotics like doxycycline but with specific considerations for resistance patterns.

• Gynecological Infections: Topical formulations have proven effective in bacterial vaginosis and pelvic inflammatory disease, with trials indicating high patient tolerability.

• Acne Vulgaris: Clindamycin topical gels remain a first-line therapy, validated by multiple clinical studies showing significant lesion reduction.

Regulatory Developments and Approvals

Recent regulatory activities focus on expanding formulary options and improving delivery systems. The USFDA approved a new topical foam formulation aimed at reducing systemic absorption adverse effects, signaling a shift towards safer, targeted therapies.

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Market Analysis of Clindamycin Hydrochloride

Current Market Size and Segmental Breakdown

As of 2022, the global Clindamycin market was estimated at approximately USD 600 million, with key segments including dermatology, gynecology, and hospital-based infections.

• Dermatology Segment: Dominates the market due to widespread use in acne vulgaris. The topical segment accounts for over 50% of sales, driven by patient preference for localized therapy.

• Hospital and Institutional Use: Infections like SSTIs and comprehensive antimicrobial regimens in hospitals constitute about 30% of market volume.

• Veterinary Applications: Though smaller, this segment accounts for roughly 10%, reflecting use in veterinary skin infections.

Regional Market Dynamics

• North America: The largest market, propelled by high antibiotic prescribing rates, advanced healthcare infrastructure, and heightened awareness of antimicrobial stewardship. The US leads, with an estimated market share exceeding 40%.

• Europe: Marked by similar trends; however, strict regulatory frameworks and resistance concerns influence usage patterns.

• Asia-Pacific: The fastest-growing region, expected to expand at a CAGR of around 6% over the next five years, due to increasing healthcare access, demographic shifts, and rising dermatological and gynecological conditions.

Driving Factors and Market Restraints

Drivers

• Rising Incidence of Bacterial Infections: Increasing cases of SSTIs, gynecological infections, and acne globally sustain demand.

• Novel Formulations and Delivery Routes: Introduction of topical foams, vaginal discs, and injectables can boost patient compliance and expand indications.

• Antimicrobial Stewardship and Resistance Management: Development of resistance-aware protocols promotes optimized, targeted use rather than broad-spectrum applications.

Restraints

• Antimicrobial Resistance (AMR): Growing prevalence of Clindamycin-resistant strains hampers reliance on current formulations, prompting the need for new therapies.

• Adverse Effect Profile: Risks like Clostridioides difficile infections and gastrointestinal disturbances limit prolonged or broad use.

• Regulatory and Economic Challenges: Stringent approvals for new formulations and cost pressures threaten profit margins.

Competitive Landscape

Major pharmaceutical companies such as Valeant Pharmaceuticals (now Bausch Health), Pfizer, and Teva dominate Clindamycin markets. Entry barriers are high owing to patent expirations and the entrenched position of generic formulations.

Emerging biotech companies focus on innovating formulations, with some exploring nanotechnology-based delivery systems to enhance bioavailability and reduce resistance.

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Market Projections and Future Trends

Growth Outlook (2023-2028)

The global Clindamycin Hydrochloride market is projected to grow at a CAGR of approximately 4-5% driven by the expansion of dermatological and gynecological indications, especially in emerging markets.

New Formulation Development and Innovation

• Extended-Release and Long-Acting Injectables: Anticipated to improve adherence, especially in patient populations with compliance challenges.

• Topical and Localized Delivery: Continued innovation in topical foams, patches, and formulations aiming to reduce systemic exposure and resistance.

• Combating Resistance: Development of synergistic combination therapies and adjunctive agents to restore efficacy against resistant strains will be pivotal.

Impact of Antimicrobial Stewardship Programs

Stewardship initiatives are likely to refocus usage towards narrow-spectrum, targeted applications, thereby stabilizing demand and prolonging the clinical relevance of Clindamycin formulations.

Regulatory Trends

Global regulatory agencies are expected to approve newer formulations with improved safety profiles, which will stimulate market growth, especially in dermatology and gynecology.

Emerging Markets and Demographic Shifts

Population growth in Asia-Pacific and Africa, coupled with increasing healthcare access, will significantly expand the market footprint. Urbanization and rising cosmetic and young adult cohorts with acne will specifically sustain topical Clindamycin demand.

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Key Takeaways

• Clinical innovation in formulations and targeted applications is shaping the future landscape, driven by the need to address antimicrobial resistance and improve patient adherence.

• Market growth remains robust, especially within dermatology and gynecology, with emerging regions poised for rapid expansion.

• Resistance management is crucial; integrated stewardship programs and combination therapies will influence prescribing patterns.

• Regulatory support for safer, more effective formulations will catalyze market expansion and renewal.

• Strategic positioning by pharmaceutical companies through innovation, regulatory navigation, and regional expansion will be essential for sustained growth.

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FAQs

1. How is antimicrobial resistance affecting the use of Clindamycin Hydrochloride?
Rising resistance, notably MLS_B phenotypes, limits Clindamycin's efficacy against certain bacterial strains, prompting the development of resistance management protocols and novel formulations to restore clinical utility.

2. Are new formulations of Clindamycin Hydrochloride in clinical development?
Yes. Innovations include topical foams, long-acting injectables, vaginal films, and combination therapies aimed at improving safety profiles, adherence, and efficacy.

3. What are the primary therapeutic indications for Clindamycin Hydrochloride?
It is primarily used to treat skin and soft tissue infections, gynecological infections such as bacterial vaginosis, and acne vulgaris, with topical applications being prevalent in dermatology.

4. How do regional market differences influence Clindamycin Hydrochloride demand?
North America and Europe constitute mature markets with steady demand, while Asia-Pacific offers high growth prospects driven by rising infection rates, dermatological conditions, and healthcare infrastructure improvements.

5. What are future challenges for Clindamycin Hydrochloride?
Key challenges include managing resistance, adverse effects, regulatory hurdles, and ensuring cost-effective formulation development to meet global demand sustainably.

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References

1. [1] World Health Organization. Antimicrobial Resistance: Global Report on Surveillance. 2014.
2. [2] U.S. Food and Drug Administration. Highlights of Safety Labeling Changes for Clindamycin. 2021.
3. [3] MarketsandMarkets. Antibiotics Market by Class, Application, Region – Forecast to 2028. 2022.
4. [4] CDC. Antibiotic Resistance Threats in the United States, 2019.
5. [5] GlobalData. Emerging Trends in Antibiotic Formulations, 2023.

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This comprehensive analysis aims to equip pharmaceutical and healthcare stakeholders with strategic insights into Clindamycin Hydrochloride’s evolving clinical and market environment, supporting informed decision-making in research, development, and commercialization.