TheraRadar
Data updated: May 26, 2026

CLARITHROMYCIN

Cytochrome P450 3A4 Inhibitors
Infectious Disease Approved 2004-05-25

CLARITHROMYCIN is indicated for the treatment of Acute Bacterial Exacerbation of Chronic Bronchitis; Acute Maxillary Sinusitis; Community-Acquired Pneumonia; Pharyngitis; Tonsillitis; Skin and Skin Structure Infections; Acute Otitis Media; Mycobacterial Infections; Helicobacter pylori Infection; Duodenal Ulcer.

Source: FDA Label • MPP PHARMA • Macrolide Antimicrobial
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How CLARITHROMYCIN Works

Clarithromycin is a macrolide antimicrobial that exerts its effect by binding to the 50S ribosomal subunit of susceptible bacteria. This action inhibits RNA-dependent protein synthesis, thereby preventing bacterial growth and replication.

Source: FDA Label
21
Indications
--
Phase 3 Trials
22
Years on Market

Details

Status
Prescription
First Approved
2004-05-25
Routes
ORAL
Dosage Forms
TABLET, EXTENDED RELEASE, TABLET, FOR SUSPENSION

Companies

MPP PHARMA Teva Sun Pharma Lupin ANI PHARMS WOCKHARDT Novartis HEC PHARM Dr. Reddy's PHARMOBEDIENT IVAX SUB TEVA PHARMS ALEMBIC Hikma NOVITIUM PHARMA CHARTWELL SUNSHINE JUBILANT CADISTA RANBAXY Aurobindo Pharma
Active Ingredient: CLARITHROMYCIN

CLARITHROMYCIN Approval History

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
296 FDA actions from 2004 to 2023
Sep 2023 SUPPL
Mfg · Manufacturing (CMC)
Aug 2023 SUPPL
Label · Labeling
Aug 2023 SUPPL
Label · Labeling

What CLARITHROMYCIN Treats

10 indications

CLARITHROMYCIN is approved for 10 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Acute Bacterial Exacerbation of Chronic Bronchitis
  • Acute Maxillary Sinusitis
  • Community-Acquired Pneumonia
  • Pharyngitis
  • Tonsillitis
  • Skin and Skin Structure Infections
  • Acute Otitis Media
  • Mycobacterial Infections
Source: FDA Label

CLARITHROMYCIN Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

DALBAVANCIN HYDROCHLORIDE
Fresenius Kabi
2025 1 indic.
PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
Dr. Reddy's
2025 8 indic.
Unlock 8 more competitors across all three rings.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to CLARITHROMYCIN

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

AZITHROMYCIN
AZITHROMYCIN
5 shared
Sun Pharma
Shared indications:
Acute Bacterial Exacerbation of Chronic BronchitisAcute Otitis MediaCommunity-Acquired Pneumonia +2 more
CEFPODOXIME PROXETIL
CEFPODOXIME PROXETIL
5 shared
ANDA REPOSITORY
Shared indications:
Acute Otitis MediaPharyngitisTonsillitis +2 more
CEFUROXIME AXETIL
CEFUROXIME AXETIL
3 shared
Lupin
Shared indications:
PharyngitisTonsillitisAcute Otitis Media
View all 20 similar drugs Pro
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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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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

CLARITHROMYCIN FDA Label Details

Indications & Usage

FDA Label (PDF)

CLARITHROMYCIN is indicated for the treatment of Acute Bacterial Exacerbation of Chronic Bronchitis; Acute Maxillary Sinusitis; Community-Acquired Pneumonia; Pharyngitis; Tonsillitis; Skin and Skin Structure Infections; Acute Otitis Media; Mycobacterial Infections; Helicobacter pylori Infection; Duodenal Ulcer.

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Data Sources

FDA Approval: ANDA203243 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.