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.
NCT00000971 ↗	The Safety and Effectiveness of Clarithromycin Plus Zidovudine or Dideoxyinosine in the Treatment of Mycobacterium Avium Complex (MAC) Infections in Children With AIDS	Completed	National Cancer Institute (NCI)	Phase 1	1969-12-31	To evaluate three doses of clarithromycin in children with AIDS and Mycobacterium avium complex (MAC) infection who are receiving concurrent antiretroviral therapy. Before more extensive evaluation of this promising drug for treatment of MAC infection in children can be done, it is important to study the pharmacokinetics of this drug in this population, to get information regarding its use in pediatric patients receiving currently available antiretroviral drugs, and to get information on the antimycobacterial activity of this drug.

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
New York	24
California	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

CLARITHROMYCIN: PATENT LANDSCAPE, CLINICAL TRIALS, AND MARKET PROJECTIONS

Last updated: February 19, 2026

Clarithromycin, a macrolide antibiotic, faces a mature market with expired primary patents. Ongoing clinical research primarily focuses on repurposing the drug for non-infectious conditions, presenting potential for niche market expansion. Generic competition dominates the infectious disease segment, limiting revenue growth for branded clarithromycin.

WHAT IS THE CURRENT PATENT STATUS OF CLARITHROMYCIN?

The primary patents covering the composition of matter and method of use for clarithromycin have expired. The original patent for clarithromycin was filed by Abbott Laboratories (now AbbVie) and has long since lapsed. For example, U.S. Patent 4,317,843, which claimed clarithromycin, expired in the early 2000s. Secondary patents related to specific formulations, manufacturing processes, or new uses may still be active, but they do not confer market exclusivity for the core drug against generic competition for its approved indications.

Key Patent Expirations:

• Composition of Matter: Expired.
• Original Method of Use (Bacterial Infections): Expired.
• Formulation Patents: May have residual protection, but generally not significant market barriers.
• Manufacturing Process Patents: Limited impact on market exclusivity for generic manufacturers.

The absence of patent protection for the core drug means that generic versions of clarithromycin are widely available and compete aggressively on price. This has led to a commoditized market for its established uses.

WHAT ARE THE RECENT CLINICAL TRIAL DEVELOPMENTS FOR CLARITHROMYCIN?

Recent clinical trials involving clarithromycin are predominantly exploring its potential in therapeutic areas beyond its traditional use against bacterial infections. These investigations are largely driven by observations of the drug's anti-inflammatory and immunomodulatory properties.

Emerging Areas of Clinical Investigation:

• Pulmonary Fibrosis: Clarithromycin has shown some anti-fibrotic effects in preclinical models. Clinical trials aim to assess its efficacy in slowing disease progression in idiopathic pulmonary fibrosis (IPF) and other fibrotic lung diseases. For instance, studies have examined its potential to reduce inflammation and extracellular matrix deposition in lung tissue.
  • Trial Examples: Phase II trials have been initiated to evaluate clarithromycin's impact on lung function decline and inflammatory markers in patients with IPF. These trials often compare clarithromycin to placebo or standard-of-care treatments.
• Inflammatory Bowel Disease (IBD): The macrolide class, including clarithromycin, has been investigated for its immunomodulatory effects that could benefit patients with Crohn's disease and ulcerative colitis. Research is exploring its ability to reduce intestinal inflammation and alter the gut microbiome.
  • Trial Examples: Small-scale trials and observational studies have explored clarithromycin as an adjunct therapy in IBD, focusing on symptom reduction and inflammatory markers.
• Other Inflammatory Conditions: Preclinical data suggests potential benefits in other inflammatory conditions, leading to exploratory clinical studies. These may include investigations into its role in certain autoimmune disorders or chronic inflammatory states, though these are generally at very early stages of research.

Established Indications and Trial Landscape:

For its approved indications, such as upper and lower respiratory tract infections, skin infections, and Helicobacter pylori eradication, there is minimal active clinical trial enrollment for clarithromycin as a standalone therapy. The focus has shifted from efficacy trials for these conditions to understanding resistance patterns and optimal use in combination therapies where it may still play a role.

Therapeutic Area	Status of Trials for Clarithromycin	Primary Focus
Bacterial Infections	Limited new development; focus on resistance management	Optimizing use in existing guidelines, stewardship programs.
Idiopathic Pulmonary Fibrosis (IPF)	Active (Phase II)	Evaluating anti-fibrotic and anti-inflammatory effects on disease progression.
Inflammatory Bowel Disease (IBD)	Exploratory (early-phase trials, observational studies)	Assessing immunomodulatory effects and impact on gut inflammation.
Other Inflammatory Conditions	Preclinical to early exploratory	Investigating broader anti-inflammatory and immunomodulatory mechanisms.

The clinical trial landscape indicates a strategic pivot for clarithromycin, moving away from competitive infectious disease markets towards niche, high-unmet-need areas where its non-antibiotic properties may offer a differentiated therapeutic profile.

WHAT IS THE CURRENT MARKET SIZE AND COMPETITIVE LANDSCAPE FOR CLARITHROMYCIN?

The global market for clarithromycin is substantial, driven by its widespread use in treating common bacterial infections. However, due to patent expirations, the market is dominated by generic manufacturers, leading to intense price competition and a mature revenue profile.

Market Size and Segmentation:

The market size for clarithromycin is estimated to be in the hundreds of millions of U.S. dollars annually. This figure fluctuates based on regional pricing, generic availability, and prescriber patterns. The primary market segments are:

1. Infectious Diseases: This segment accounts for the vast majority of clarithromycin sales. It includes treatments for:

   • Respiratory tract infections (pneumonia, bronchitis, sinusitis)
   • Skin and soft tissue infections
   • Helicobacter pylori eradication (in combination therapy)
   • Other bacterial infections (e.g., pertussis)

2. Niche/Repurposed Indications: This segment is currently small but represents potential growth areas. It includes investigational uses in:

   • Idiopathic Pulmonary Fibrosis (IPF)
   • Inflammatory Bowel Disease (IBD)
   • Other chronic inflammatory conditions

Competitive Landscape:

The competitive landscape is characterized by:

• Generic Dominance: Numerous pharmaceutical companies manufacture and market generic clarithromycin. Key players include Teva Pharmaceutical Industries, Mylan N.V. (now part of Viatris), Sanofi S.A. (through its generics division), and a multitude of smaller regional manufacturers.
• Price-Based Competition: With multiple generic suppliers, the primary competitive lever is price. This has driven down profit margins for manufacturers and increased affordability for healthcare systems and patients.
• Brand Loyalty (Declining): While original branded clarithromycin (e.g., Biaxin by AbbVie) may retain some market share due to established physician familiarity and perceived quality, the price differential with generics is significant, limiting its competitive edge.
• Limited Differentiation: For established infectious disease indications, there is little to differentiate between generic products beyond price and availability.
• Emerging Players in Repurposing: Should clinical trials for non-infectious indications prove successful, new market entrants or existing players seeking to leverage clarithromycin's established safety profile could emerge. However, these would likely be specialty pharmaceutical companies or divisions focused on rare diseases or novel therapeutics.

Key Competitors (Generic Manufacturers - examples):

• Teva Pharmaceutical Industries
• Viatris Inc.
• Sun Pharmaceutical Industries Ltd.
• Dr. Reddy's Laboratories Ltd.
• Aurobindo Pharma Ltd.
• Zydus Lifesciences Ltd.

The current market for clarithromycin is a classic example of a post-patent-expiration scenario. The focus for established players is on market share and cost-efficient production. The primary opportunity for value creation lies in successfully navigating the clinical development and regulatory pathways for novel indications, where new intellectual property or differentiated clinical value could command premium pricing.

WHAT ARE THE MARKET PROJECTIONS FOR CLARITHROMYCIN?

Market projections for clarithromycin are bifurcated, reflecting its mature status in established indications and its nascent potential in repurposed therapeutic areas.

Projections for Established Indications (Infectious Diseases):

The market for clarithromycin in treating bacterial infections is projected to experience low single-digit compound annual growth rate (CAGR), or potentially stagnation, over the next five to ten years.

• Factors Limiting Growth:
  • Widespread Generic Availability: Intense price competition among generic manufacturers caps revenue growth.
  • Antibiotic Resistance: Increasing bacterial resistance to macrolides, including clarithromycin, may lead to reduced efficacy and a shift towards alternative antibiotics in some regions and for specific pathogens.
  • Development of New Antibiotics: The ongoing development of novel antibiotic classes and agents with broader spectrums or improved resistance profiles could gradually displace clarithromycin for certain indications.
  • Stewardship Programs: Global efforts to promote antibiotic stewardship may lead to more judicious prescribing of clarithromycin, particularly for less severe infections where alternatives exist.
• Factors Supporting Stable Demand:
  • Established Efficacy and Safety Profile: For many common infections, clarithromycin remains an effective and well-tolerated treatment option with a long history of use.
  • Affordability: As a generic drug, it remains an economically attractive option for healthcare systems and patients.
  • Regional Demand: Continued high prevalence of certain bacterial infections in developing economies will sustain demand.

Projections for Repurposed Indications (e.g., IPF, IBD):

The market potential for clarithromycin in new indications such as idiopathic pulmonary fibrosis (IPF) or inflammatory bowel disease (IBD) is highly speculative and depends entirely on successful clinical trial outcomes and regulatory approvals.

• Scenario 1: Successful Repurposing: If clarithromycin demonstrates significant clinical benefit in well-controlled Phase III trials and gains regulatory approval for indications like IPF, it could create a niche market with significant growth potential.
  • Market Value: A successful repurposing could establish a new revenue stream, potentially in the tens to hundreds of millions of dollars annually, depending on the indication's prevalence, unmet need, and pricing.
  • Competitive Advantage: Unlike the generic market, a repurposed clarithromycin would likely benefit from new intellectual property (e.g., method of use patents for the specific indication) and a differentiated therapeutic profile, allowing for premium pricing.
  • Key Players: Companies that successfully navigate the development and approval process for these new uses could capture this value. This might involve specialty pharmaceutical companies or existing players focusing on specific disease areas.
• Scenario 2: Clinical Trial Failures or Limited Efficacy: If clinical trials do not demonstrate sufficient efficacy or safety for repurposed indications, this market segment will remain negligible.
• Potential Timeframe: Significant market impact from repurposed indications, if successful, is likely 5-10 years away, factoring in the lengthy development, trial, and approval timelines.

Overall Market Projection Summary:

Market Segment	Projected CAGR (Next 5-10 Years)	Key Drivers
Infectious Diseases	0% to 2%	Stable demand from established efficacy and affordability vs. antibiotic resistance, new alternatives, and stewardship programs.
Repurposed Indications (Potential)	Highly Variable (0% to significant)	Success in clinical trials, regulatory approvals, unmet medical need in target diseases (e.g., IPF, IBD). Highly speculative.

In summary, the established market for clarithromycin is mature and stable, offering limited growth. The significant future value for clarithromycin hinges on its successful repositioning into novel therapeutic areas, a path fraught with clinical and regulatory uncertainty.

Key Takeaways

• Clarithromycin's primary patents have expired, leading to a market dominated by generic competition and price erosion for its established uses in bacterial infections.
• Current clinical research is focused on repurposing clarithromycin for non-infectious inflammatory and fibrotic conditions, particularly idiopathic pulmonary fibrosis (IPF) and inflammatory bowel disease (IBD).
• The market for clarithromycin in infectious diseases is projected to grow at a low single-digit CAGR due to factors such as antibiotic resistance and stewardship, offset by its established efficacy and affordability.
• Successful clinical development and regulatory approval for repurposed indications could create new, high-value niche markets for clarithromycin, but this path is highly speculative and carries significant development risk.

Frequently Asked Questions

1. Are there any active patents for clarithromycin that could impact generic manufacturing?

While primary composition of matter and method of use patents have expired, secondary patents related to specific polymorphic forms, improved manufacturing processes, or novel drug delivery systems may exist. However, these are typically narrow in scope and may not prevent generic manufacturers from producing standard clarithromycin formulations once the core patent protection has lapsed.

2. What are the main challenges in repurposing clarithromycin for non-infectious diseases?

The primary challenges include demonstrating statistically significant clinical efficacy in rigorous, large-scale trials, establishing a clear mechanistic link for its non-antibiotic effects (e.g., anti-inflammatory, anti-fibrotic), and navigating regulatory approval pathways for new indications. Furthermore, physician education and market adoption for a drug historically known as an antibiotic will be crucial.

3. How significant is the threat of antibiotic resistance to clarithromycin's current market share?

Antibiotic resistance is a significant and growing concern. Increased resistance rates can reduce clarithromycin's efficacy, leading to treatment failures and a preference for alternative antibiotics. This trend, coupled with global antibiotic stewardship initiatives, is a key factor limiting growth in its traditional infectious disease applications.

4. What is the typical cost difference between branded and generic clarithromycin?

The cost difference can be substantial, often ranging from 50% to over 90% less for generic clarithromycin compared to its original branded form (e.g., Biaxin). This price differential is a primary driver of generic market penetration.

5. In the context of potential repurposing, what is the regulatory pathway for clarithromycin?

If clarithromycin is to be approved for new indications such as IPF, it would require a New Drug Application (NDA) or supplemental NDA filing, depending on the jurisdiction. This process involves submitting extensive data from preclinical studies and multi-phase clinical trials (Phase I, II, and III) to regulatory bodies like the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA) to demonstrate safety and efficacy for the proposed new use.

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[1] U.S. Patent 4,317,843. (1982). US Patent and Trademark Office. [2] AbbVie Inc. (n.d.). Biaxin® (clarithromycin) prescribing information. [3] ClinicalTrials.gov. (n.d.). Search results for Clarithromycin. [4] European Medicines Agency. (n.d.). Search for information on medicines. [5] Food and Drug Administration. (n.d.). Drug Information Database.