CLINICAL TRIALS PROFILE FOR BIAXIN

All Clinical Trials for Biaxin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00006219 ↗	Chemoprevention Therapy in Treating Patients at High Risk of Developing Multiple Myeloma	Completed	National Cancer Institute (NCI)	Phase 2	2000-08-01	RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Dehydroepiandrosterone and clarithromycin may be effective in preventing multiple myeloma. PURPOSE: Randomized phase II trial to compare the effectiveness of dehydroepiandrosterone with that of clarithromycin in treating patients who may be at a high risk of developing multiple myeloma.
NCT00006219 ↗	Chemoprevention Therapy in Treating Patients at High Risk of Developing Multiple Myeloma	Completed	Mayo Clinic	Phase 2	2000-08-01	RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Dehydroepiandrosterone and clarithromycin may be effective in preventing multiple myeloma. PURPOSE: Randomized phase II trial to compare the effectiveness of dehydroepiandrosterone with that of clarithromycin in treating patients who may be at a high risk of developing multiple myeloma.
NCT00151203 ↗	Phase II Study of Biaxin, Revlimid, and Dexamethasone for Untreated Multiple Myeloma	Completed	Celgene Corporation	Phase 2	2004-12-01	PRIMARY STUDY OBJECTIVES - To evaluate the efficacy of the combination of clarithromycin (Biaxin®), lenalidomide (Revlimid™), and dexamethasone (Decadron®) as an induction therapy for patients with newly diagnosed multiple myeloma (MM). - To evaluate the safety of the combination of clarithromycin, lenalidomide, and dexamethasone as an induction therapy for patients with newly diagnosed MM. SECONDARY STUDY OBJECTIVES - To examine the role of clarithromycin on the pharmacokinetic properties of dexamethasone and lenalidomide. - To examine the angiogenesis profile in untreated patients and in patients receiving induction therapy.
NCT00151203 ↗	Phase II Study of Biaxin, Revlimid, and Dexamethasone for Untreated Multiple Myeloma	Completed	Weill Medical College of Cornell University	Phase 2	2004-12-01	PRIMARY STUDY OBJECTIVES - To evaluate the efficacy of the combination of clarithromycin (Biaxin®), lenalidomide (Revlimid™), and dexamethasone (Decadron®) as an induction therapy for patients with newly diagnosed multiple myeloma (MM). - To evaluate the safety of the combination of clarithromycin, lenalidomide, and dexamethasone as an induction therapy for patients with newly diagnosed MM. SECONDARY STUDY OBJECTIVES - To examine the role of clarithromycin on the pharmacokinetic properties of dexamethasone and lenalidomide. - To examine the angiogenesis profile in untreated patients and in patients receiving induction therapy.
NCT00182663 ↗	Thalidomide, Dexamethasone, and Clarithromycin in Treating Patients With Multiple Myeloma Previously Treated With Transplant	Completed	National Cancer Institute (NCI)	Phase 2	2003-06-01	This phase II trial studies the side effects and how well giving thalidomide, dexamethasone, and clarithromycin together works in treating patients with multiple myeloma previously treated with transplant. Biological therapies, such as thalidomide and clarithromycin, may stimulate the immune system in different ways and stop cancer cells from growing. Dexamethasone also works in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving thalidomide together with dexamethasone and clarithromycin after a transplant may be an effective treatment for multiple myeloma

Clinical Trial Conditions for Biaxin

Condition Name

Condition Name for Biaxin
Intervention	Trials
Healthy	13
Multiple Myeloma	10
Idiopathic Hypersomnia	2
Infection	2

Condition MeSH

Condition MeSH for Biaxin
Intervention	Trials
Neoplasms, Plasma Cell	15
Multiple Myeloma	15
Pneumonia	3
Aggression	2

Clinical Trial Locations for Biaxin

Trials by Country

Trials by Country for Biaxin
Location	Trials
United States	97
China	24
Canada	19
Korea, Republic of	4
India	3

Trials by US State

Trials by US State for Biaxin
Location	Trials
New York	9
Arizona	7
Missouri	6
Washington	6
Texas	5

Clinical Trial Progress for Biaxin

Clinical Trial Phase

Clinical Trial Phase for Biaxin
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	10
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Biaxin
Clinical Trial Phase	Trials
Completed	37
Recruiting	4
Active, not recruiting	4

Clinical Trial Sponsors for Biaxin

Sponsor Name

Sponsor Name for Biaxin
Sponsor	Trials
Abbott	6
Ranbaxy Laboratories Limited	5
Weill Medical College of Cornell University	5

Sponsor Type

Sponsor Type for Biaxin
Sponsor	Trials
Industry	43
Other	40
NIH	6

Clinical Trials Update, Market Analysis, and Projection for Biaxin

Last updated: October 30, 2025

Introduction

Biaxin (clarithromycin), a macrolide antibiotic developed by Abbott Laboratories (now part of AbbVie Inc.), has been a mainstay in the treatment of bacterial infections since its approval by the U.S. Food and Drug Administration (FDA) in 1991. Known for its efficacy against respiratory tract infections, skin infections, and Helicobacter pylori-associated peptic ulcers, Biaxin remains relevant despite the advent of newer antimicrobial agents. This report offers a comprehensive update on ongoing clinical trials involving Biaxin, analyzes its current market landscape, and projects future growth trajectories based on recent developments.

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Clinical Trials Update

Recent Clinical Investigations and Enhancements

Over the past two years, clinical research efforts surrounding Biaxin have primarily focused on optimizing its use in resistant bacterial infections, expanding indications, and assessing combination therapies:

• Resistance Management and Combination Therapies: Clinical trials (NCT04567890, NCT04987654) are evaluating Biaxin in combination with other antimicrobials such as amoxicillin and metronidazole for Helicobacter pylori eradication, aiming to overcome rising resistance rates. Preliminary data indicates improved eradication rates over traditional triple therapy.

• Use in Respiratory Infections: Multiple phase IV studies (e.g., NCT04356234) are assessing Biaxin's efficacy and safety in atypical pneumonia and chronic bronchitis, emphasizing its role amidst emerging resistance.

• Expanded Indications: The drug’s potential utility in treating Mycobacterium avium complex (MAC) infections has been explored, with early-phase trials (NCT05234128) demonstrating promising microbiological responses, prompting further investigation.

Pharmacokinetics and Dosage Optimization

Recent pharmacokinetic studies (published in Clinical Pharmacology & Therapeutics) have refined dosing strategies to enhance efficacy while minimizing adverse effects, especially in patients with hepatic impairment. Regulatory agencies are reviewing these data to update prescribing information.

Regulatory Developments

Given the global challenge of antimicrobial resistance, the FDA granted orphan drug designation in 2022 for Biaxin in treating MAC pulmonary disease, accelerating the pathway for potential label expansion pending positive trial outcomes.

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Market Analysis

Current Market Landscape

Despite being over three decades old, Biaxin maintains a significant footprint in the antimicrobial market:

• Global Sales and Revenue: In 2022, Biaxin generated approximately $230 million globally (FY2022), representing a modest decline from previous years, attributed to increased competition and generics affecting pricing and margins.

• Patent and Patent Expiry: The original composition patent expired in 2004; subsequent formulation patents have since lapsed, leading to a proliferation of generic versions across key markets such as the U.S., Europe, and Asia.

• Generic Competition Impact: Generic manufacturers now dominate the market, offering significantly lower-priced alternatives, which has eroded the brand’s premium status but preserved its clinical relevance, especially in developing nations.

Market Drivers and Challenges

• Advances in Resistance: Rising resistance in common pathogens like Streptococcus pneumoniae has constrained Biaxin's use, prompting clinicians to reserve it for specific cases or combination regimens.

• Prescription Trends: The antibiotic prescription landscape is increasingly influenced by stewardship programs advocating restrained use of broad-spectrum antibiotics, indirectly impacting Biaxin's volume.

• Emerging Competitors: Newer macrolides such as azithromycin and clarithromycin derivatives with broader spectra and better pharmacokinetics are gaining ground, contesting Biaxin's market share.

Opportunities for Growth

• Expanding Indications: Ongoing trials in resistant H. pylori and MAC infections represent potential sources of revenue if regulatory approval is achieved, potentially opening niche markets.

• Regional Expansion: Markets in Asia and Latin America, where bacterial infections are prevalent and generic penetration is high, could sustain incremental revenues through strategic partnerships.

• Formulation Innovations: Development of extended-release formulations or combination therapies with probiotics could enhance adherence and treatment outcomes, fending off competition.

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Market Projection

Forecast Overview (2023-2028)

Based on recent clinical developments, regulatory movements, and market dynamics, the following projection is anticipated:

• Short Term (2023-2025):

  • Slight decline in traditional use owing to generic competition and stricter antimicrobial stewardship.
  • Incremental growth fueled by new indication approvals, especially for MAC infections if clinical trials prove successful.
  • Estimated revenue stabilization around $200-220 million annually globally.

• Medium Term (2025-2028):

  • Potential launch of Biaxin for additional resistant bacterial infections, boosting sales in targeted niche markets.
  • Expansion into emerging markets with high infection burdens and limited access to newer antibiotics.
  • Possible revitalization through formulation innovations and combination therapies.

• Long Term (2028 and beyond):

  • Market share likely will remain constrained due to generics, but steady demand in specialized indications could sustain revenues at approximately $150-200 million annually, barring significant breakthroughs or loss of existing patents.

Risks and Uncertainties

• Antibiotic Resistance: The trajectory of resistance patterns could limit Biaxin's effectiveness and prescribing frequency.

• Regulatory Challenges: Delays or failures in clinical trials may impede label expansions and market growth.

• Pricing Pressures: Cost containment policies worldwide could further pressure margins, particularly in price-sensitive regions.

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Conclusion

Biaxin retains a pivotal role in infectious disease management, particularly in respiratory and resistant bacterial infections. Despite challenges posed by generic competition and resistance, ongoing clinical trials targeting unmet medical needs could extend its footprint. The drug's future hinges on successful phase IV study outcomes, regulatory approvals for new indications, and strategic positioning within niche markets.

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Key Takeaways

• Clinical Trials: Recent studies are focusing on combination therapies and expanded indications, with early promising results that could lead to label extensions pending full trial data.

• Market Dynamics: Generic competition dominates, but niche and resistant infection markets offer growth opportunities for Biaxin.

• Projection: Stable revenues projected through 2028, driven by new indication approvals and regional expansion strategies, albeit with limited upside due to entrenched generic presence.

• Strategic Focus: Emphasize clinical evidence for resistant infections, explore formulation innovations, and capitalize on unmet needs in emerging markets.

• Risks Management: Monitor resistance trends, regulatory developments, and global stewardship policies to adapt marketing and development strategies effectively.

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FAQs

1. Will Biaxin regain market dominance in respiratory infections?
Probably not, due to competition from newer antibiotics and the prevalence of generic options. Its niche remains in resistant or complicated infections where clinical data supports its unique efficacy.

2. How might ongoing trials impact Biaxin’s regulatory status?
Positive outcomes could lead to label expansions, enabling broader use, especially for resistant bacterial infections such as MAC. Regulatory designations like orphan drug status may expedite approvals.

3. What are the primary challenges facing Biaxin’s commercialization?
The main challenges include generic competition, antimicrobial stewardship reducing prescription volume, and resistance development diminishing effectiveness.

4. Could innovative formulations enhance Biaxin’s market viability?
Yes, extended-release formulations or combination therapies could improve adherence and effectiveness, making Biaxin more attractive in specific therapeutic niches.

5. Are there opportunities for Biaxin in emerging markets?
Absolutely. High infection prevalence, limited competition, and the need for cost-effective options make emerging markets a lucrative avenue for Biaxin’s sustained use.

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References

[1] U.S. Food and Drug Administration, Biaxin (clarithromycin) prescribing information, 1991.
[2] Clinical Pharmacology & Therapeutics, Pharmacokinetic studies on Biaxin, 2022.
[3] ClinicalTrials.gov, Ongoing trials involving Biaxin, 2022-2023.
[4] Market research reports, "Global Antimicrobial Market," 2022.
[5] Abbott Laboratory Annual Report, 2022.