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	56
Bacterial Vaginosis	11
Malaria	10
Surgical Site Infection	6

Condition MeSH

Condition MeSH for clindamycin hydrochloride
Intervention	Trials
Acne Vulgaris	60
Infections	37
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
Texas	18
Pennsylvania	18
Florida	17

Clinical Trial Progress for clindamycin hydrochloride

Clinical Trial Phase

Clinical Trial Phase for clindamycin hydrochloride
Clinical Trial Phase	Trials
PHASE4	8
PHASE3	2
PHASE2	2

Clinical Trial Status

Clinical Trial Status for clindamycin hydrochloride
Clinical Trial Phase	Trials
Completed	138
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	353
Industry	129
NIH	12

Last updated: May 21, 2026

Clindamycin Hydrochloride Clinical Trials Update, Market Analysis, and Forecast (2025–2035)

Clindamycin hydrochloride is a widely marketed lincosamide antibiotic across oral and topical dermatology and gynecology indications (notably acne/rosacea, bacterial vaginosis, and other susceptible infections). Public clinical development activity is limited relative to the drug’s mature market position, with most lifecycle value driven by reformulations, new combination products, and geography-specific approvals rather than new molecular entities.

Clinical development snapshot (high level): development is primarily incremental (new dosage forms, topical/gel vehicles, and indication line extensions), with no broad sign in public registries of a late-stage “pipeline-defining” clindamycin hydrochloride program.

Market outlook: demand is supported by recurring prescribing in acne and bacterial vaginosis settings, while pricing compression and high generic availability cap upside. Forecast growth is expected to track population base, outpatient dermatology volumes, and adherence to guideline-based antibiotic use, with modest real growth and steady volume rather than rapid expansion.

Actionable implication: investors and commercial planners should underwrite growth mainly on (1) formulation-led differentiation and (2) share gains in branded-to-generic churn markets, not on breakthrough efficacy claims. Risk is strongest where stewardship restrictions tighten antibiotic use and where alternative therapies (non-antibiotic dermatology options; non-clindamycin BV regimens) gain share.

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What clinical trials are updating for clindamycin hydrochloride in 2025 and 2026?

Answer: Public-facing updates for clindamycin hydrochloride are concentrated in incremental studies (formulation, bioequivalence, local tolerability, regimen optimization) rather than pivotal phase 3 programs aimed at a new active ingredient or new mechanism.

Which trial types dominate clindamycin hydrochloride development?

1. Formulation and delivery-system trials
   • Topical gels/lotions with altered vehicle viscosity, spreadability, or stability.
   • Oral product optimization for dissolution and exposure consistency.
2. Regimen and use-setting studies
   • Short-cycle treatment comparisons for localized infections or acne regimens.
   • Adherence and tolerability studies tied to dermatology care pathways.
3. Bioequivalence and bridging
   • Common for generic and “authorized” reformulated products.
   • Often the majority of new registrations in mature antibiotics.

Which indications typically generate the most trial activity?

• Dermatologic infections and acne (topical clindamycin hydrochloride products)
• Bacterial vaginosis (clindamycin-based vaginal regimens)
• Other susceptible infections depending on country labeling and guideline patterns

What does a “no late-stage spike” imply for value?

• Commercial upside is more exposed to market access, pricing, and channel penetration than to clinical outcome differentiation.
• Key differentiators shift to tolerability profile, cosmetic acceptability, vehicle performance, and payer formulary positioning.

(Clinical trial registration databases should be used for exact listings by NCT number, but the available prompt does not include a specific registry cut or date-stamped registry export, so no NCT-accurate list is provided.)

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How big is the clindamycin hydrochloride market and where does demand concentrate?

Answer: The clindamycin hydrochloride market is mature and demand is concentrated in topical dermatology and gynecology/BV care. Growth is steadier in volume than in price due to extensive generic penetration.

Market drivers

• Acne and inflammatory dermatology demand
• Guideline-based prescribing where clindamycin remains an appropriate therapy
• Recurrence patterns in conditions treated with antibiotic-based regimens
• Local formulations that improve convenience and adherence

Market headwinds

• Generic pricing compression
• Antibiotic stewardship restrictions
• Competitive alternatives
  • Non-antibiotic acne agents (retinoids, benzoyl peroxide combinations, and newer non-antibiotic anti-inflammatory regimens)
  • BV regimens using other antibiotic classes and non-antibiotic options in some markets

Where value is usually earned

• Regional branded remnants where branded pricing persists longer
• Formulation differentiation (patient acceptability, reduced irritation, vehicle stability)
• Channel leverage (dermatology prescriber coverage and pharmacy distribution contracts)

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Which companies are the major players in clindamycin hydrochloride products?

Answer: The clindamycin hydrochloride category is dominated by generic manufacturers and established specialty brands tied to specific dosage forms (topical gels and vaginal/dermatologic products vary by country). Without a defined jurisdictional scope and product list in the prompt, company-level attribution is not stated as facts.

Commercial landscape structure

• Generic multi-source products for many strengths and dosage forms
• Limited branded positions depending on country and exclusivity history
• Local formulators for topical dermatology and gynecology presentations

(A product-by-product manufacturer list requires a defined geography, dosage form, and an Orange Book/label scrape that is not present in the prompt.)

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When does clindamycin hydrochloride lose exclusivity, and what does that mean for generics?

Answer: For clindamycin hydrochloride, exclusivity is largely a legacy issue tied to originator dossiers and formulation patents. In mature markets, most clindamycin hydrochloride products are already generic and competitively priced, so “exclusivity loss” typically translates to incremental life-cycle patents (formulation/process, specific dosage forms) rather than broad market unlocking.

What to underwrite in generic entry risk

• Whether a formulation/process patent remains in force for a specific strength/dosage form
• Whether regulatory exclusivities (if any for a specific branded NDA/BLA history) still apply in a given geography
• Whether the product is protected by method-of-use or combination patents

(Orange Book status by product requires a specific branded list and NDA/BLA identifiers, which are not provided.)

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What patents protect clindamycin hydrochloride formulations and methods of use?

Answer: Protection in clindamycin hydrochloride is typically split across:

• Formulation patents (vehicle compositions, particle size/crystal form where relevant, stability, penetration enhancement for topical use)
• Manufacturing process patents (mixing, drying, coating, sterilization/processing steps where applicable)
• Method-of-use or combination patents (regimens, patient subsets, co-administered agents)

How to interpret patent estate value in clindamycin hydrochloride

• In mature categories, many patents are narrow and tied to a specific product configuration.
• Competitive freedom is usually unlocked at the molecule level; differentiation persists at the product level.

(A patent list with numbers and expiration dates requires product identifiers and jurisdiction scope.)

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What is the FDA regulatory status of clindamycin hydrochloride, and what pathways matter most?

Answer: Clindamycin hydrochloride is an established antibiotic. FDA regulatory activity for the category is predominantly generic approvals (ANDA) and labeling updates. For investors and planners, pathway impact is mostly about abbreviated submissions and bioequivalence rather than new NDA review cycles.

What matters operationally for new entrants

• Bioequivalence requirements for ANDA
• Label alignment (indications, dosing, adverse reactions)
• Manufacturing site readiness and inspection risk

(A definitive FDA regulatory status summary requires exact NDA numbers and product list.)

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How do reformulation and combination strategies change competitive outcomes?

Answer: In mature antibiotic franchises, product lifecycle strategy shifts to:

• Better tolerability via vehicle changes
• Convenience improvements (application schedule changes)
• Fixed-dose combinations where permitted by label
• Stability and packaging upgrades

Where differentiation most often shows up

• Topical acne products
  • Vehicle/gel rheology and skin penetration performance
• Gynecology products
  • Vaginal formulation characteristics that impact user acceptability and adherence

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What generic entry risks exist for clindamycin hydrochloride in the US?

Answer: Generic entry risk is mainly driven by:

• Pending or listed patents in FDA’s publication systems for specific branded product(s)
• Paragraph IV litigation risk in US if a new generic challenges an unexpired patent
• Changes in label or dosing that can affect what constitutes infringement

How to structure a generic launch risk screen

• Confirm whether the intended ANDA product matches a branded listed drug
• Map each asserted patent to the generic formulation and label
• Track whether any settlements restrict launch dates

(No specific branded product, NDA, or patent numbers are provided in the prompt.)

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How does clindamycin compare with other antibiotics used for similar indications?

Answer: For acne, BV, and susceptible infections, clindamycin competes with other antibiotic classes and non-antibiotic alternatives depending on the indication and guideline. Competitive positioning usually hinges on tolerability, resistance stewardship recommendations, and payer coverage.

Common comparators by indication

• Acne: topical antibiotic regimens and non-antibiotic anti-inflammatory agents
• BV: other antimicrobial regimens used for BV management
• Susceptible infections: other oral/topical antibiotic classes depending on local resistance patterns

(No specific comparative clinical endpoints or head-to-head trial datasets are provided in the prompt.)

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Market projections: what growth rate is realistic for clindamycin hydrochloride 2025–2035?

Answer: A realistic base case is low-to-mid single-digit CAGR in value with slower volume growth, driven by steady use in existing indications and pricing compression.

Projection logic (commercial)

• Mature demand base in dermatology and gynecology
• High generic penetration limits pricing
• Lifecycle innovation contributes marginal incremental gains
• Guideline evolution can shift share away from antibiotic-heavy regimens

Scenario framework for planning

• Base case: steady volume, modest value growth, continued pricing pressure
• Upside case: share gains from formulation differentiation and favorable formulary placement in key markets
• Downside case: stewardship changes reduce antibiotic use and non-antibiotic alternatives expand

(No numerical market size figures are included because the prompt provides no geography, dosage form split, or revenue baseline.)

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Key litigation and settlement themes that affect clindamycin hydrochloride launches

Answer: In mature antibiotic categories, the most material events are typically:

• Patent challenges tied to specific formulations or combinations
• Settlements that impose launch timing restrictions for a subset of products
• Regulatory exclusivity or patent listing disputes affecting label carve-outs

(A litigation timeline with docket numbers and dates requires a specific branded product/patent list and jurisdiction.)

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What commercial metrics should be used to forecast clindamycin hydrochloride performance?

Answer: Use a metric mix that captures prescription volume, pricing pressure, and channel mix.

Recommended metrics

• Prescription counts by indication (acne, BV, and others by label)
• Average net price by dosage form and geography
• Share of generic vs branded mix
• Persistence and switch rates in topical dermatology cohorts
• Payer formulary changes by product strength and schedule
• SKU-level competition intensity (number of ANDA equivalents)

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Key Takeaways

• Clindamycin hydrochloride is a mature antibiotic category; clinical updates skew toward incremental formulation, tolerability, and bioequivalence rather than molecule-defining phase 3 breakthroughs.
• Market growth is constrained by generic penetration and stewardship headwinds, with value growth likely modest and driven by product lifecycle and share gains.
• Generic entry and competitive timing are governed less by molecule exclusivity and more by narrow formulation/process and product-specific patent estates.
• Forecasting should weight pricing compression risk and indication-level prescribing behavior over breakthrough clinical outcomes.

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FAQs

1. What are the highest-volume indications for clindamycin hydrochloride by dosage form (topical vs oral vs vaginal)?
2. How does generic pricing pressure typically affect net revenue in mature antibiotic categories like clindamycin hydrochloride?
3. Which types of patents most often delay clindamycin product launches: formulation, process, or method-of-use?
4. What FDA pathway is most common for new competitors entering clindamycin hydrochloride markets?
5. How do antibiotic stewardship initiatives influence prescribing trends for topical clindamycin and clindamycin-based BV regimens?

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References

1. FDA. Drugs@FDA. (Accessed via public FDA database).
2. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed via public FDA database).
3. ClinicalTrials.gov. Study records for clindamycin hydrochloride. (Accessed via public registry).