CLINICAL TRIALS PROFILE FOR CLARITHROMYCIN

505(b)(2) Clinical Trials for Clarithromycin

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 Combination	NCT02188368 ↗	Pomalidomide for Lenalidomide for Relapsed or Refractory Multiple Myeloma Patients	Active, not recruiting	Celgene Corporation	Phase 2	2014-08-01	The purpose of this clinical research study is to evaluate the safety and effectiveness (good and bad effects) of pomalidomide given as part of a combination therapy that include more than just steroids to treat subjects with relapsed (subjects whose disease came back) or refractory (subjects whose disease did not respond to past treatment) multiple myeloma (MM). Pomalidomide (alone or in combination with dexamethasone) has been approved by the United States Food and Drug Administration (FDA) for the treatment of MM patients who have received at least two prior therapies, including lenalidomide and bortezomib, and have demonstrated disease progression on or within 60 days of completion of their last therapy. However, the use of pomalidomide in combination with other drugs used to treat MM, such as chemotherapeutic agents and proteasome inhibitors, is currently being tested and is not approved. Pomalidomide is in the same drug class as thalidomide and lenalidomide. Like lenalidomide, pomalidomide is a drug that alters the immune system and it may also interfere with the development of small blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. The testing done with pomalidomide thus far has shown that it is well-tolerated and effective for subjects with MM both on its own and in combination with dexamethasone. Using another drug class, namely proteasome inhibitors, we have demonstrated that simply replacing a proteasome inhibitor with another in an established anti-myeloma treatment regimen can frequently overcome resistance regardless of the other agents that are part of the anti-myeloma regimen. Importantly, the toxicity profile of the new combinations closely resembled that of the proteasome inhibitor administered as a single agent. Based on this experience, we hypothesize that the replacement of lenalidomide with pomalidomide will yield similar results in a similar relapsed/refractory MM patient population.
New Combination	NCT02188368 ↗	Pomalidomide for Lenalidomide for Relapsed or Refractory Multiple Myeloma Patients	Active, not recruiting	Oncotherapeutics	Phase 2	2014-08-01	The purpose of this clinical research study is to evaluate the safety and effectiveness (good and bad effects) of pomalidomide given as part of a combination therapy that include more than just steroids to treat subjects with relapsed (subjects whose disease came back) or refractory (subjects whose disease did not respond to past treatment) multiple myeloma (MM). Pomalidomide (alone or in combination with dexamethasone) has been approved by the United States Food and Drug Administration (FDA) for the treatment of MM patients who have received at least two prior therapies, including lenalidomide and bortezomib, and have demonstrated disease progression on or within 60 days of completion of their last therapy. However, the use of pomalidomide in combination with other drugs used to treat MM, such as chemotherapeutic agents and proteasome inhibitors, is currently being tested and is not approved. Pomalidomide is in the same drug class as thalidomide and lenalidomide. Like lenalidomide, pomalidomide is a drug that alters the immune system and it may also interfere with the development of small blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. The testing done with pomalidomide thus far has shown that it is well-tolerated and effective for subjects with MM both on its own and in combination with dexamethasone. Using another drug class, namely proteasome inhibitors, we have demonstrated that simply replacing a proteasome inhibitor with another in an established anti-myeloma treatment regimen can frequently overcome resistance regardless of the other agents that are part of the anti-myeloma regimen. Importantly, the toxicity profile of the new combinations closely resembled that of the proteasome inhibitor administered as a single agent. Based on this experience, we hypothesize that the replacement of lenalidomide with pomalidomide will yield similar results in a similar relapsed/refractory MM patient population.
New Combination	NCT03124199 ↗	Rifaximin Associated With Classic Triple Therapy for the Eradication of Helicobacter Pylori Infection	Completed	Fundación de Investigación Biomédica - Hospital Universitario de La Princesa	Phase 3	2014-02-01	Background: A progressive decrease in Helicobacter pylori eradication rates has been described over the years, so new combinations of antibiotics for treatment are needed. Aim: To evaluate the efficacy and safety of the addition of rifaximin to standard triple therapy (omeprazole, amoxicillin and clarithromycin) for the eradication of H. pylori. Methods: Independent prospective pilot clinical trial (EUDRA CT: 2013-001080-23). Forty consecutive adult patients were included with H. pylori infection, dyspeptic symptoms and naive to eradication treatment. A full blood test was performed in the first 5 patients included to evaluate the safety of the treatment. H. pylori eradication was confirmed with urea breath test at least 4 weeks after the end of treatment. Treatment: Rifaximin 400 mg/8 h, clarithromycin 500 mg/12 h, amoxicillin 1 g/12 h, and omeprazole 20 mg/12 h for 10 days.

All Clinical Trials for Clarithromycin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000644 ↗	A Phase II Safety and Efficacy Study of Clarithromycin in the Treatment of Disseminated M. Avium Complex (MAC) Infections in Patients With AIDS	Completed	Abbott	Phase 2	1969-12-31	This study is designed to evaluate the efficacy and safety of clarithromycin given orally at 1 of 3 doses to treat disseminated Mycobacterium avium complex infections (MAC) in patients with AIDS. Mycobacterium avium complex (MAC) is thought to be the most common disseminated bacterial opportunistic infection in AIDS, with clinical prevalence estimates ranging from 15 to 50 percent of all AIDS patients. Clarithromycin, a new macrolide antimicrobial agent, has demonstrated activity against MAC both in the laboratory and in animals. Clinical experience treating AIDS patients with clarithromycin for disseminated MAC is limited. However, early studies have indicated few adverse effects and some improvement in clinical symptoms scores and Karnofsky performance scores over placebo treated patients.
NCT00000644 ↗	A Phase II Safety and Efficacy Study of Clarithromycin in the Treatment of Disseminated M. Avium Complex (MAC) Infections in Patients With AIDS	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	This study is designed to evaluate the efficacy and safety of clarithromycin given orally at 1 of 3 doses to treat disseminated Mycobacterium avium complex infections (MAC) in patients with AIDS. Mycobacterium avium complex (MAC) is thought to be the most common disseminated bacterial opportunistic infection in AIDS, with clinical prevalence estimates ranging from 15 to 50 percent of all AIDS patients. Clarithromycin, a new macrolide antimicrobial agent, has demonstrated activity against MAC both in the laboratory and in animals. Clinical experience treating AIDS patients with clarithromycin for disseminated MAC is limited. However, early studies have indicated few adverse effects and some improvement in clinical symptoms scores and Karnofsky performance scores over placebo treated patients.
NCT00000794 ↗	Phase II Randomized Open-Label Trial of Atovaquone Plus Pyrimethamine and Atovaquone Plus Sulfadiazine for the Treatment of Acute Toxoplasmic Encephalitis	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To evaluate the efficacy, safety, and tolerance of atovaquone with either pyrimethamine or sulfadiazine in AIDS patients with toxoplasmic encephalitis. AIDS patients with toxoplasmic encephalitis who receive the standard therapy combination of sulfadiazine and pyrimethamine experience a high frequency of severe toxicity. Atovaquone, an antibiotic that has demonstrated efficacy against toxoplasmosis in animal models and in preclinical testing has been well tolerated, is now available as a suspension, which is more readily absorbed than the tablet form of the drug. The efficacy and safety of atovaquone in combination with sulfadiazine or pyrimethamine will be studied.
NCT00000826 ↗	Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole-Trimethoprim and Dapsone and Their Hydroxylamine Metabolites	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To determine the effects of fluconazole and either rifabutin or clarithromycin, alone and in combination, on the pharmacokinetics of first sulfamethoxazole-trimethoprim and then dapsone in HIV-infected patients. Although prophylaxis for more than one opportunistic infection is emerging as a common clinical practice in patients with advanced HIV disease, little is known about possible adverse drug interactions. The need exists to define pharmacokinetics and pharmacodynamic adverse interactions of the many combination prophylactic regimens that may be prescribed.

Clinical Trial Conditions for Clarithromycin

Condition Name

Condition Name for Clarithromycin
Intervention	Trials
Helicobacter Pylori Infection	136
Healthy	30
Multiple Myeloma	16
HIV Infections	15

Condition MeSH

Condition MeSH for Clarithromycin
Intervention	Trials
Helicobacter Infections	109
Infections	98
Infection	73
Communicable Diseases	64

Clinical Trial Locations for Clarithromycin

Trials by Country

Trials by Country for Clarithromycin
Location	Trials
United States	351
China	73
Taiwan	47
Korea, Republic of	30
Canada	27

Trials by US State

Trials by US State for Clarithromycin
Location	Trials
California	24
New York	24
Texas	22
Maryland	18
Florida	17

Clinical Trial Progress for Clarithromycin

Clinical Trial Phase

Clinical Trial Phase for Clarithromycin
Clinical Trial Phase	Trials
PHASE4	17
PHASE3	7
PHASE2	7

Clinical Trial Status

Clinical Trial Status for Clarithromycin
Clinical Trial Phase	Trials
Completed	252
Recruiting	61
Unknown status	57

Clinical Trial Sponsors for Clarithromycin

Sponsor Name

Sponsor Name for Clarithromycin
Sponsor	Trials
National Taiwan University Hospital	20
Abbott	17
Xijing Hospital of Digestive Diseases	10

Sponsor Type

Sponsor Type for Clarithromycin
Sponsor	Trials
Other	500
Industry	161
NIH	17

Last updated: May 20, 2026

Clarithromycin Clinical Trials Update, Market Analysis, and Price- and Patent-Driven Sales Projections (2026–2035)

Clarithromycin, a macrolide antibiotic (ATC J01FA09), remains a mature, off-patent global brand and generic product. Market growth is primarily driven by (1) persistent respiratory and Mycobacterium avium complex (MAC) use patterns, (2) guideline-adjacent demand for Helicobacter pylori (H. pylori) eradication regimens, and (3) manufacturer execution in high-volume generic markets. Near-term clinical-trials activity is concentrated in comparative effectiveness, resistance-strategy regimens (often combined therapies), and special-population studies rather than new-drug discovery.

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What is the current clarithromycin clinical trials landscape (2024–2026)?

Clarithromycin’s trial footprint in 2024–2026 is dominated by three categories: regimen comparisons for H. pylori eradication, resistance-informed therapy optimization in respiratory infections, and MAC-related studies (often in the context of guideline adherence and real-world safety).

What trial types are most common for clarithromycin?

1. H. pylori eradication regimen trials
   • Comparative or add-on studies evaluating clarithromycin-based combinations versus alternatives, typically influenced by clarithromycin resistance prevalence by region.
2. Community-acquired respiratory infection studies
   • Trials assessing clinical outcomes and microbiology in outpatient populations, with endpoints tied to symptom resolution and adverse events.
3. MAC and nontuberculous mycobacterial (NTM) supportive studies
   • Studies focused on safety, adherence, tolerability, and regimen performance, often in older cohorts.

Where are clarithromycin trials concentrated geographically?

• Trials skew toward Asia-Pacific and Europe for H. pylori regimen comparisons, reflecting local resistance gradients and payer-driven guideline adoption cycles.
• Respiratory infection trials are commonly global multicenter, with enrollment designed to capture routine care outcomes.

What endpoints matter most in the current trial mix?

• Microbiological eradication (H. pylori)
• Clinical cure and time to symptom improvement (respiratory)
• Safety and tolerability (GI events, QT-risk monitoring where relevant)
• Resistance emergence signals in regimen comparison studies

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How does clarithromycin fit into H. pylori eradication strategies as resistance rises?

Clarithromycin’s commercial relevance remains tied to whether it stays in the regimen mix. Resistance has pushed many regions toward non-clarithromycin regimens (metronidazole- or bismuth-based, and other guideline-preferred combinations), which changes the addressable market size by geography and indication mix.

Which clarithromycin-based H. pylori regimens are most scrutinized?

• Triple therapy variants using clarithromycin plus a proton pump inhibitor and another antibiotic (often amoxicillin or metronidazole).
• Sequential or concomitant therapy approaches where clarithromycin is paired with multi-antibiotic strategies to offset resistance.

What does resistance mean for trial design and uptake?

• Trials now more frequently stratify by region-specific resistance prevalence and assess eradication rates in pragmatic settings, not only controlled conditions.
• Payers and formularies tend to follow trial-adjacent guideline updates with regional resistance thresholds, which directly impacts volume conversion from “prescribable” to “preferred.”

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What patents and exclusivity constrain clarithromycin brand economics?

Clarithromycin’s core active ingredient is long off primary patent protection in most jurisdictions, so exclusivity is not the primary driver of market power. Instead, the competitive landscape is shaped by:

• regulatory exclusivity for specific formulations or combinations (where present),
• brand-to-generic switching policies, and
• manufacturing cost and quality systems.

How many years of exclusivity remain for clarithromycin?

• Primary compound exclusivity is effectively exhausted in the major markets; current economics reflect generic competition rather than patent-monopoly pricing.

What is the Orange Book status of clarithromycin?

• Clarithromycin is widely present as approved generic entries across the US; any remaining exclusivity is generally limited to specific NDA/ANDA-level formulation or packaging exclusivities rather than new chemical entity protection.

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What is the clarithromycin market size and growth outlook (2026–2030)?

Clarithromycin is a high-volume, lower-margin antibiotic product. Growth is limited by:

• replacement by alternative antibiotics in resistant regions,
• stewardship pressure,
• generic price erosion, and
• a mature prescriber base.

Revenue drivers that still support demand

1. Continued MAC therapy and outpatient respiratory use
2. Persistent need for eradication regimens
3. Institutional formularies that keep clarithromycin available even where it is not first-line
4. Generic availability supporting broad access and volume stability

Revenue headwinds

• Clarithromycin resistance reducing eradication success in regions where clarithromycin remains part of standard regimens
• Stewardship and prescribing restriction programs
• Margin compression from multi-supplier generic competition

Market projection (directional, 2026–2030)

• Volume: stable to low-growth in mature markets; higher volatility in regions with guideline transitions.
• Value: modest growth in nominal terms driven by pricing normalization effects in specific geographies, offset by ongoing generic erosion.

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How does clarithromycin compare with azithromycin and amoxicillin-clavulanate for respiratory indications?

For routine respiratory infection indications, clarithromycin competes with newer or better-positioned macrolides and broad-spectrum beta-lactams. The key differentiation is not clinical superiority universally, but:

• regional guideline positioning,
• resistance patterns, and
• cost and formulary access.

Competitive substitution patterns

• Macrolide class substitution: azithromycin often captures share when clarithromycin resistance or adverse event perceptions reduce use.
• Beta-lactam alternatives: amoxicillin-clavulanate often expands when resistance supports beta-lactam coverage or when macrolide stewardship is tighter.

Implications for sales projections

• Clarithromycin’s best-case value stability depends on maintaining its role in specific guideline pathways (including certain H. pylori regimens) and on avoiding rapid formulary downgrades in resistance-heavy geographies.

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What generic entry risks exist for clarithromycin (US Paragraph IV, EU, and other markets)?

Because clarithromycin is off primary patent protection, “Paragraph IV” dynamics for the molecule typically do not drive near-term competitive risk the way they do for pipeline products. The meaningful risks shift to:

• manufacturing quality events,
• supply chain disruptions,
• price competition intensity, and
• any remaining regulatory exclusivity on specific product forms.

What drives generic risk in off-patent antibiotics?

• ANDA approvals already saturate the molecule’s footprint.
• “Risk” is less about litigation and more about tender cycles, contracting, and market share capture among generics.

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How strong is the clarithromycin patent estate for new defensible products (formulations and combinations)?

The molecule itself has limited remaining IP value in most major markets. Defensibility tends to come from:

• fixed-dose combinations,
• controlled-release formulations,
• novel dosing regimens, and
• lifecycle management around specific label claims.

What formulation or method-of-use strategies are most plausible?

• Regimen-level claims tied to resistant H. pylori settings
• Patient subpopulation claims (where supported by evidence)
• Delivery or tolerability improvements, if any new approvals exist

Commercial impact

• Lifecycle IP is more likely to protect revenue streams for specific branded or specialty presentations, not to prevent generic erosion on the base product.

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Which companies dominate clarithromycin supply, and how does it affect pricing?

Clarithromycin’s supplier market is typically fragmented with many generic manufacturers. Pricing is shaped by:

• tender-based competition,
• regional distributor power,
• FDA/EMA compliance record,
• lot release consistency and supply availability.

What does this mean for projection assumptions?

• Base case: continued generic price pressure
• Upside case: regional scarcity, contracting cycles, or higher guideline alignment with clarithromycin-inclusive regimens
• Downside case: accelerated substitution away from clarithromycin due to resistance guideline shifts

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Regulatory and FDA pathway: what is the practical approval status of clarithromycin?

In mature markets, clarithromycin’s clinical development focus shifts toward label refinements and regimen optimization rather than new approvals as an active ingredient. Most products are generics, with some region-specific labeling differences for indication scope.

What matters for market access?

• label positioning (indication-specific)
• local resistance-adaptive guideline recommendations
• reimbursement coverage rules for H. pylori eradication regimens

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What is the clarithromycin safety and monitoring profile that influences market access?

Safety considerations influence prescribing behavior and payer tolerance, especially in respiratory and older patients.

Key safety themes used in regimen selection

• GI adverse effects are common in macrolide therapies
• QT prolongation risk considerations can affect use in susceptible patients
• Drug-drug interaction management (notably with other QT-prolonging agents)

Commercial implication

• Safety-driven caution can reduce uptake in high-risk outpatient segments, especially where alternative agents are preferred.

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Market projection model: what will likely happen to clarithromycin unit and revenue through 2035?

Base-case projection

• Unit demand: stable to low growth, with growth in regions where clarithromycin remains guideline-adjacent for H. pylori and where MAC regimens remain entrenched.
• Revenue: flat to modest decline in real terms, with nominal fluctuations tied to price floors and tender cycles.

Upside scenarios

• Resistant-regimen performance in pragmatic trials leads to sustained guideline inclusion in additional regions
• Improved tolerability or simplified regimen dosing supports adherence, sustaining utilization

Downside scenarios

• Continued withdrawal from clarithromycin-containing standard H. pylori regimens in resistance-heavy regions
• Accelerated macrolide stewardship reduces outpatient respiratory prescribing share

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Key Takeaways

• Clarithromycin is a mature, off-patent antibiotic where the clinical-trials mix centers on regimen optimization rather than new drug discovery.
• Market growth is modest and geography-sensitive, driven by resistance-adaptive guideline use in H. pylori and stable demand in selected respiratory and MAC use cases.
• Competitive dynamics are dominated by generic supplier availability and pricing pressure, not by exclusivity or patent enforcement.
• Near-term revenue outcomes through 2030 are likely flat to modest, with value erosion offset by stable volume and contracting cycles.
• Through 2035, the main swing factor is guideline placement tied to clarithromycin resistance patterns, not IP.

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FAQs

1. Which clarithromycin-based H. pylori regimens are still recommended in high-resistance regions?
2. How do clarithromycin resistance rates shift comparative trial outcomes across countries?
3. What are the most common safety drivers that affect clarithromycin prescribing in older adults?
4. What generic market dynamics most influence clarithromycin price in hospital tenders?
5. How does clarithromycin utilization compare with azithromycin in outpatient respiratory care under stewardship rules?

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References (APA)

1. FDA. (n.d.). Drugs@FDA: FDA Approved Drug Products. U.S. Food and Drug Administration.
2. EMA. (n.d.). European public assessment reports (EPAR) and product information for clarithromycin-containing medicines. European Medicines Agency.
3. WHO Collaborating Centre for Drug Statistics Methodology. (n.d.). ATC/DDD Index. World Health Organization.