Data updated: May 26, 2026
BIAXIN XL (clarithromycin)
Infectious Disease
Approved 1993-12-23
4
Indications
--
Phase 3 Trials
32
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1993-12-23
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE, TABLET
BIAXIN XL Approval History
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
35 FDA actions from 1993 to 2019 · 2 indication expansions
Dec 2008 SUPPL
Label
Dec 2002 SUPPL
Mfg
May 2002 SUPPL
Efficacy
Mar 2002 SUPPL
Label
Nov 2001 SUPPL
Mfg
Dec 1993 ORIGINAL
Update
What BIAXIN XL Treats
4 FDA approvalsOriginally approved for its first indication in 1993 . Covers 4 distinct patient populations.
- Other (4)
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Clinical Trial Registry
91 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04310930 FORMaT | U1111-1209-0672 | Ph 2, Ph 3 | recruiting | Finding the Optimal Regimen for Mycobacterium Abscessus Treatment |
| NCT07341100 | SKB264-Ⅱ-19 | Ph 2 | recruiting | Study to Evaluate the Preliminary Efficacy of SKB264 and the Effect of Clarithromycin on the PK of SKB264 in OC |
| NCT02343042 STOMP | KCP-330-017 | Ph 1, Ph 2 | active not recruiting | Selinexor and Backbone Treatments of Multiple Myeloma Patients |
| NCT04630145 results posted | CR108897 TMC207NTM3002 | Ph 2, Ph 3 | completed | A Study of Bedaquiline Administered as Part of a Treatment Regimen With Clarithromycin and Ethambutol in Adult Patients With Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD) |
| NCT07485010 FORMaT-EVOLVE | FORMaT002 | Ph 2 | not yet recruiting | Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial |
| NCT06837259 | C4921008 2024-520126-11-00 | Ph 1 | completed | A Study to Learn if Study Medicines Called Cyclosporine and Clarithromycin Affect How the Body Processes the Other Study Medicine Called PF-07328948 in Healthy Adults |
| NCT01298336 CAMOMY | PHRCN10-DR-ANDREJAK-MELLE | Ph 3 | completed | Treatment of Mycobacterium Xenopi Pulmonary Infection |
| NCT04302324 results posted | 19-12021155 | Ph 2 | active not recruiting | A Phase II Study of Daratumumab, Clarithromycin, Pomalidomide And Dexamethasone (D-ClaPd) In Multiple Myeloma Patients Previously Exposed to Daratumumab |
| NCT01745588 | 12-138 | Ph 2 | completed | Autologous Stem Cell Transplant With Pomalidomide (CC-4047®) Maintenance Versus Continuous Clarithromycin/ Pomalidomide / Dexamethasone Salvage Therapy in Relapsed or Refractory Multiple Myeloma |
| NCT01559935 CarBiRD results posted | 1108011903 | Ph 2 | active not recruiting | Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD] Therapy for Subjects With Multiple Myeloma |
| NCT07040787 | HRS-5965-107 | Ph 1 | completed | Investigation of Drug-drug Interaction of HRS-5965 With Clopidogrel and Clarithromycin in Healthy Subjects |
| NCT04026958 | IRB00108681 1R01NS111280 | Ph 2 | completed | Clarithromycin Mechanisms in Hypersomnia Syndromes |
| NCT06514274 | KY20242226-C-1 | Ph 4 | completed | Study on The Efficacy and Safety of Vonoprazan-containing Berberine Triple Therapy in Helicobacter Pylori First-Line Eradication |
| NCT05742568 | KY20222310-C-1 | Ph 4 | completed | Effects of High-dose Dual Therapy and Bismuth Quadruple Therapy for Helicobacter Pylori Eradication on Intestinal Microecology |
| NCT06523764 | KY20242230-C-1 | Ph 4 | active not recruiting | Efficacy and Safety of Tegoprazan and Minocycline Dual Therapy for Helicobacter Pylori Initial Treatment |
| NCT07021729 | RMI/RMI-REC/approval/181 | Ph 4 | not yet recruiting | Comparison of Two Treatment Regimens of Helicobacter Pylori Infection |
| NCT06964334 | vit D supplement h.pylori | Ph 3 | not yet recruiting | The Effect of Vitamin D Supplement as Adjuvant Therapy in Eradication of Helicobacter Pylori Infection |
| NCT06227832 | KP-001-102 | Ph 1 | completed | A Study to Determine the Effect of KP-001 on Metformin and Midazolam Pharmacokinetics and the Effect of Clarithromycin on KP-001 Pharmacokinetics in Healthy Adult Participants |
| NCT06823791 | 1234567 | Ph 1, Ph 2 | completed | Furazolidone Quadruple Regimen Eradicate H. Pylori Infection |
| NCT06576882 VOTE-HP | 0306630 | Ph 3 | completed | 7 Days vs. 14 Days of Vonoprazan-based Triple Therapy for H. Pylori Eradication |
| NCT03800550 | CR108570 2018-004302-25, TMC207NTM1001 | Ph 1 | completed | A Study to Assess the Drug-Drug Interaction Between Bedaquiline and Clarithromycin in Healthy Adult Participants |
| NCT04551963 results posted | BGB-3111-113 | Ph 1 | completed | Interaction Study of Zanubrutinib With Moderate and Strong CYP3A Inhibitors in Participants With B-Cell Malignancies |
| NCT06551623 | TNP-2198-10 | Ph 1 | completed | Drug-Drug Interactions Between TNP-2198 and Midazolam, Clarithromycin |
| NCT02542657 | 728937 UCDCC#253, X16043 | Ph 1, Ph 2 | active not recruiting | Ixazomib with Pomalidomide, Clarithromycin and Dexamethasone in Treating Patients with Multiple Myeloma |
| NCT06162949 | 0306381 | Ph 3 | completed | Vonoprazan for Helicobacter Pylori Eradication in Adolescents |
| NCT05845567 results posted | ITF/2357/55 - PART 2 2021-005756-11 | Ph 1 | completed | The Potential of Givinostat as DDI Victim in Co-administration P-gp Inhibitor (Part 2) |
| NCT05965570 | INS1007-109 | Ph 1 | completed | A Study to Investigate Effect of Clarithromycin, a Strong CYP3A4 Inhibitor, on Brensocatib Pharmacokinetics in Healthy Participants |
| NCT04843579 ClaSPd results posted | 20-12023093 | Ph 2 | terminated | Treatment of Selinexor in Combination With Clarithromycin, Pomalidomide and Dexamethasone for Relapsed Refractory Multiple Myeloma Patients |
| NCT04198363 results posted | Vonoprazan-3002 | Ph 3 | completed | A Study to Evaluate the Efficacy and Safety of Bismuth-Containing Quadruple Therapy With Oral Vonoprazan (TAK-438) 20 mg Compared to Esomeprazole 20 mg Twice Daily in Paticipants With Helicobacter Pylori Infection |
| NCT04753437 results posted | Vonoprazan-1001 U1111-1257-0258 | Ph 1 | completed | A Study of Vonoprazan in Adults With Helicobacter Pylori |
| NCT05049902 | 2021-SDU-QILU-G001-2 | Ph 4 | completed | Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication |
| NCT05915871 | NE822202 | Ph 1 | completed | Drug Interaction Study Between Tegoprazan, Bismuth, Amoxicillin and Clarithromycin |
| NCT05716854 | SCR-014 | Ph 1 | completed | Electrophysiological Effects of Potential QT Prolonging Drugs |
| NCT02516696 BiRd vs Rd results posted | 1411015662 RV-CL-MM-PI-004078 | Ph 3 | terminated | BiRd vs. Rd as Initial Therapy in Multiple Myeloma |
| NCT05861687 | LB.02.01.XV.III.2.2.2/344/2022 | Ph 2, Ph 3 | completed | Recurrence Rate Comparison Between Esomeprazole and Lansoprazole in Eradicating Helicobacter Pylori Infection Among Children |
| NCT05342532 results posted | STUDY-19-01590 | Ph 4 | completed | High Dose Dual Therapy vs Clarithromycin Triple Therapy for Treatment Naive H Pylori Infection in an Urban Population |
| NCT05014334 | KY20212155-C-1 | Ph 4 | completed | Study on The Efficacy and Safety of Berberine-containing Triple Therapy in Helicobacter Pylori First-Line Eradication |
| NCT04697186 | KY20202119 | Ph 4 | completed | Helicobacter Pylori Eradication With Berberine Plus Amoxicillin Triple Therapy Versus Bismuth-containing Quadruple Therapy |
| NCT05469126 | 18507 J2A-MC-GZGM | Ph 1 | completed | A Drug Interaction Study of Clarithromycin and LY3502970 in Healthy Participants |
| NCT03366974 CYP_IVPO | CYP_IVPO | Ph 1 | completed | Assessment of Change in CYP3A Activity by Route of Administration Using Metabolic Markers in Healthy Male Volunteers |
| NCT02975037 | CYP3A_DDI | Ph 1 | completed | Evaluation of Metabolic Markers for the Prediction of DDI of Various CYP3A Substrates and Inhibitors |
| NCT01503606 | 2011-07-005 | Ph 3 | completed | Duration of Antibiotics Treatment With Cefazolin and Clarithromycin in Women With Preterm Premature Rupture of Membrane |
| NCT04167670 results posted | HP-301 2019-002668-28 | Ph 3 | completed | Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Helicobacter Pylori Infection |
| NCT05237115 | K111111 | Ph 4 | completed | Helicobacter Pylori Eradication With Probiotics Combined With Triple Therapy Versus Bismuth-containing Quadruple Therapy |
| NCT05137600 | ANTT103 | Ph 1 | completed | A Drug-Drug Interaction Study Between ATI-2173 and Midazolam or Clarithromycin in Healthy Subjects |
| NCT03709355 | HIV-VM1500-08 | Ph 1 | completed | Pharmacokinetics Study to Evaluate Drug-Drug Interactions and Safety of Elpida® in Co-Administration With Other Drugs |
| NCT02969928 results posted | AmxMetClmCFA | Ph 2, Ph 3 | completed | Two Different Antibiotic Agents to Treat Generalized Aggressive Periodontitis |
| NCT05061732 | B2021-376 | Ph 4 | recruiting | Helicobacter Pylori Eradication and Follow-up |
| NCT04398004 ACHIEVE | ACHIEVE 2020-001882-36 | Ph 2 | completed | Anti-inflammatory Clarithromycin for Improving COVID-19 Infection Early |
| NCT03345992 INCLASS | INCLASS | Ph 3 | completed | Benefit of Clarithromycin in Patients With Severe Infections Through Modulation of the Immune System |
Showing 50 of 91 trials
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BIAXIN XL FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.