Biaxin

(clarithromycin)

ApprovedSmall molecule

Clarithromycin is an antibiotic used to treat bacterial infections such as respiratory tract infections, ear infections, and skin infections. It works by stopping bacteria from growing and multiplying.[2] Biaxin is currently approved and in use across 41 indications[4].[1]

Biaxin is one of 526 small molecule programs targeting Multiple Myeloma. It is currently in Approved.

Indications

214

Total Trials

Active Trials

525

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Multiple MyelomaUnknown status

Helicobacter PyloriCompleted

Bronchiolitis ObliteransApproved

Idiopathic HypersomniaApproved

Venous ThromboembolismApproved

Chronic Lymphocytic LeukemiaApproved

Gastric CancerApproved

Buruli Ulcer DiseaseApproved

Preterm Premature Rupture of the MembranesApproved

Recurrent Lower Respiratory Tract InfectionsActive, not recruiting

Multiple MyelomaPhase 3

Unknown status

Helicobacter PyloriApproved

Completed

Bronchiolitis ObliteransApproved

Approved

Idiopathic HypersomniaApproved

Approved

Venous ThromboembolismApproved

Approved

Chronic Lymphocytic LeukemiaApproved

Approved

Gastric CancerApproved

Approved

Buruli Ulcer DiseaseApproved

Approved

Preterm Premature Rupture of the MembranesApproved

Approved

Recurrent Lower Respiratory Tract InfectionsPreclinical

Active, not recruiting

Showing 10 of 41 indications

Competition

Competitive Landscape

282 competitors in Multiple Myeloma

#DrugCompanyPhaseTrials

Biaxin

AbbVie

Approved

15 2

Sarclisa

AAzienda U.S.L. 1 di Massa e Carrara

Phase 3

42 3

Xpovio

KKaryopharm Therapeutics Inc

Phase 3

29 4

Neulasta

Amgen

Phase 3

5 5

Busulfex

Akero Therapeutics

Phase 3

15 6

BLENREP

GGlaxo Dba Glaxosmithkline

Phase 3

10 7

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 3

9 8

Cevostamab

Roche

Phase 3

9 9

CM336

KKeymed Biosciences Co.Ltd

Phase 3

1 10

SCTC21C

SSinocelltech Ltd.

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Post-ApprovalRecruiting

PPROM

NCT06396078

Q3 2027

N/ARecruiting

Helicobacter Pylori Eradication

NCT05926804

Q4 2027

Phase 2Active, not recruiting

Multiple Myeloma

NCT04302324

Q2 2028

Phase 2Not yet recruiting

Efficacy

NCT07341100

Clinical

Trials by Indication[1]

Interaction13 trials

Pharmacokinetic Interactions of Quadruple Therapy With Anaprazole/Amoxicilin/Clarithromycin/Bismuth

Unknown status·SSihuan Pharmaceutical Holdings Group Ltd.·Phase 1·NCT04444011·32 enrolled

Drug-Drug Interaction Study Between CJ-12420 and Clarithromycin in Healthy Male Subjects

Completed·HHK inno.N Corporation·Phase 1·NCT02052336·24 enrolled

Drug Interaction Study on Linaprazan Glurate Capsules

Completed·JJiangsu Sinorda Biomedicine Co., Ltd·Phase 1·NCT07294846·56 enrolled

Show 10 more trials

TAK-438_110 Drug Interaction With Cytochrome P450 3A4 (CYP3A4) Inhibitor Clarithromycin

Completed· Takeda logo

Takeda·Phase 1·NCT02774902·16 enrolled

A Drug Interaction Study of KW-6356 and Clarithromycin or Rifampicin

Completed· Kyowa Kirin Co., Ltd. logo

Kyowa Kirin Co., Ltd.·Phase 1·NCT04070495·20 enrolled

A Drug-Drug Interaction Study Between ATI-2173 and Midazolam or Clarithromycin in Healthy Subjects

Completed·AAntios Therapeutics, Inc·Phase 1·NCT05137600·36 enrolled

Investigation of Drug-drug Interaction of HRS-5965 With Clopidogrel and Clarithromycin in Healthy Subjects

Completed·CChengdu Suncadia Medicine Co., Ltd.·Phase 1·NCT07040787·36 enrolled

TAK-438 Bismuth Drug Interaction Study

Completed· Takeda logo

Takeda·Phase 1·NCT02892409·30 enrolled

The PK and PD Interaction Between YH4808, Amoxicillin and Clarithromycin in Healthy Subjects

Completed·YYuhan Corporation·Phase 1·NCT01921647·95 enrolled

Drug Interaction Study Between Tegoprazan, Bismuth, Amoxicillin and Clarithromycin

Completed·SShandong Luoxin Pharmaceutical Group Stock Co., Ltd.·Phase 1·NCT05915871·22 enrolled

Dabigatran in an Interaction Probe Drug Cocktail

Completed·TTurku University Hospital·Phase 1·NCT02361619·16 enrolled

Drug-Drug Interaction Study of Colchicine and Clarithromycin

Completed·MMutual Pharmaceutical Company, Inc.·Phase 1·NCT00984061·24 enrolled

A Study to Assess the Drug-Drug Interaction Between Bedaquiline and Clarithromycin in Healthy Adult Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03800550·16 enrolled

Helicobacter Pylori Eradication13 trials

Helicobacter Pylori Eradication Study

Completed·IInje University·Phase 4·NCT03130452·423 enrolled

A "Screen and Treat" Helicobacter Pylori Eradication Trial in Adolescents in Three Regions of Chile

Recruiting·MMiguel O'Ryan Gallardo·N/A·NCT05926804·500 enrolled

Amoxicillin/Metronidazole Based Quadruple Therapy for Helicobacter Pylori Eradication

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT02175901·215 enrolled

Show 10 more trials

Effectiveness of Minocycline-Containing Bismuth Quadruple Therapy for Helicobacter Pylori Eradication

Unknown status·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 4·NCT04558502·339 enrolled

Effects of High-dose Dual Therapy and Bismuth Quadruple Therapy for Helicobacter Pylori Eradication on Intestinal Microecology

Completed·XXijing Hospital of Digestive Diseases·Phase 4·NCT05742568·124 enrolled

Efficacy Comparison of Vonoprazan Combined With Different Antibiotics in Dual Therapy for Helicobacter Pylori Eradication: A Prospective, Randomized Controlled Clinical Trial

Recruiting·YYongquan Shi·Phase 4·NCT07068607·400 enrolled

Vonoprazan for Helicobacter Pylori Eradication in Adolescents

Completed·—·Phase 3·NCT06162949·242 enrolled

Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication: A Randomized Clinical Trial of 10 and 14 Days

Unknown status·SShandong University·Phase 4·NCT04901117·1,300 enrolled

Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication

Completed·SShandong University·Phase 4·NCT05049902·1,300 enrolled

Drug Use Surveillance of Takecab for "Supplement to Helicobacter Pylori Eradication"

Completed· Takeda logo

Takeda··NCT03219723·560 enrolled

Helicobacter Pylori Eradication With Berberine Quadruple Therapy Versus Clarithromycin Quadruple Therapy

Completed·XXijing Hospital of Digestive Diseases·Phase 4·NCT02633930·566 enrolled

Helicobacter Pylori Eradication With Berberine Plus Amoxicillin Triple Therapy Versus Bismuth-containing Quadruple Therapy

Completed·XXijing Hospital of Digestive Diseases·Phase 4·NCT04697186·524 enrolled

Helicobacter Pylori Eradication With Probiotics Combined With Triple Therapy Versus Bismuth-containing Quadruple Therapy

Completed·XXijing Hospital of Digestive Diseases·Phase 4·NCT05237115·600 enrolled

Helicobacter Pylori13 trials

Study of Nitazoxanide (NTZ) for Helicobacter Pylori in Children

Recruiting·TTanta University·Phase 3·NCT04415983·100 enrolled

Compare Sequential and Quadruple Therapy for the Eradication of Helicobacter Pylori in Korea

Completed·SSeoul National University Bundang Hospital·N/A·NCT02159976·390 enrolled

The Evaluation of Triple Therapy With Vonoprazan, Amoxicillin and Bismuth for Eradication of Helicobacter Pylori

Unknown status·HHuazhong University of Science and Technology·N/A·NCT05189444·672 enrolled

Show 10 more trials

Effect of Vitamin D on Drug Resistant Helicobacter Pylori (HP) Eradication Study

Unknown status·—·Phase 3·NCT03142620·96 enrolled

Tailored Therapy for Helicobacter Pylori Rescue Treatment

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT03413020·200 enrolled

A Study of Vonoprazan in Adults With Helicobacter Pylori

Completed· Takeda logo

Takeda·Phase 1·NCT04753437·44 enrolled

Antimicrobial Susceptibility Testing Guided Triple Therapy in Salvage Helicobacter Pylori Treatment

Unknown status·YYanqing Li·Phase 4·NCT03139253·120 enrolled

The Effect of Broccoli Sprout Extract and Probiotics for Eradication of Helicobacter Pylori

Unknown status·KKyunghee University Medical Center·Phase 4·NCT03220542·360 enrolled

The Epidemiology and Optimal Treatment of Helicobacter Pylori in Myanmar

Completed·KKirby Institute·Phase 4·NCT04132479·313 enrolled

Evaluation of Saccharomyces Boulardii Combined With Standard Quadruple Therapy for Eradication of Helicobacter Pylori

Completed·HHuazhong University of Science and Technology·N/A·NCT03688828·360 enrolled

Effectiveness of Rifabutin for Treatment of Helicobacter Pylori

Unknown status·RRabin Medical Center·Phase 3·NCT04652284·300 enrolled

Tailored Versus Empiric Therapy for Helicobacter Pylori Treatment

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT02935010·382 enrolled

Study of Nitazoxanide (NTZ) Based New Therapeutic Regimens for Helicobacter Pylori

Unknown status·SSherief Abd-Elsalam·Phase 3·NCT02422706·120 enrolled

Helicobacter Pylori Infection12 trials

The Effects of a Synbiotic Addition on Eradication Therapy of Helicobacter Pylori Infection in Children

Completed·—·N/A·NCT03165253·69 enrolled

Non-invasive Test-guided Tailored Therapy Versus Empiric Treatment for Helicobacter Pylori Infection.

Unknown status·UUniversity of Bari·Phase 3·NCT04107194·362 enrolled

Recurrence Rate Comparison Between Esomeprazole and Lansoprazole in Eradicating Helicobacter Pylori Infection Among Children

Completed·FFinni Kollins·Phase 2/3·NCT05861687·51 enrolled

Show 9 more trials

15-day Sequential Therapy for Helicobacter Pylori Infection in Korea

Completed·SSeoul National University Bundang Hospital·Phase 4·NCT01887249·287 enrolled

Lactobacillus Reuteri in Management of Helicobacter Pylori Infection in Dyspeptic Patients

Completed·ZZagazig University·N/A·NCT01593592·70 enrolled

Intraluminal Therapy for Helicobacter Pylori Infection

Completed·MMackay Memorial Hospital·Phase 4·NCT03124420·100 enrolled

Quadruple vs Tailored Therapy in the Treatment of Helicobacter Pylori Infection

Completed·UUniversity of Split, School of Medicine·N/A·NCT04621487·80 enrolled

Comparison of Two Treatment Regimens of Helicobacter Pylori Infection

Not yet recruiting·RRehman Medical Institute - RMI·Phase 4·NCT07021729·156 enrolled

Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Helicobacter Pylori Infection

Completed·PPhathom Pharmaceuticals, Inc.·Phase 3·NCT04167670·1,046 enrolled

Efficacy of Therapy Based on Fecal Molecular Antimicrobial Susceptibility Tests for Helicobacter Pylori Infection

Unknown status·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 4·NCT05718609·855 enrolled

The Effect of Vitamin D Supplement as Adjuvant Therapy in Eradication of Helicobacter Pylori Infection

Not yet recruiting·—·Phase 3·NCT06964334·70 enrolled

Intraluminal Clarithromycin Powder Monotherapy for Helicobacter Pylori Infection

Completed·MMackay Memorial Hospital·Phase 4·NCT03516669·20 enrolled

Multiple Myeloma12 trials

Treatment of Selinexor in Combination With Clarithromycin, Pomalidomide and Dexamethasone for Relapsed Refractory Multiple Myeloma Patients

Terminated·WWeill Medical College of Cornell University·Phase 2·NCT04843579·4 enrolled

Clarithromycin Plus CTd Regimen for Patients With Newly Diagnosed Multiple Myeloma

Unknown status·JJinling Hospital, China·Phase 3·NCT02248428·130 enrolled

A Phase II Study of Daratumumab, Clarithromycin, Pomalidomide And Dexamethasone (D-ClaPd) In Multiple Myeloma Patients Previously Exposed to Daratumumab

Active, not recruiting·WWeill Medical College of Cornell University·Phase 2·NCT04302324·9 enrolled

Show 9 more trials

Chemoprevention Therapy in Treating Patients at High Risk of Developing Multiple Myeloma

Completed·MMayo Clinic·Phase 2·NCT00006219

Phase II Study of Thalidomide, Clarithromycin, Lenalidomide, and Dexamethasone for Newly Diagnosed Multiple Myeloma

Completed·WWeill Medical College of Cornell University·Phase 2·NCT00538733·26 enrolled

BiRd vs. Rd as Initial Therapy in Multiple Myeloma

Terminated·WWeill Medical College of Cornell University·Phase 3·NCT02516696·12 enrolled

Autologous Stem Cell Transplant With Pomalidomide (CC-4047®) Maintenance Versus Continuous Clarithromycin/ Pomalidomide / Dexamethasone Salvage Therapy in Relapsed or Refractory Multiple Myeloma

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT01745588·23 enrolled

Lenalidomide, Dexamethasone, and Clarithromycin in Treating Patients Who Have Undergone Stem Cell Transplant for Multiple Myeloma

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT00445692·32 enrolled

Thalidomide, Dexamethasone, and Clarithromycin in Treating Patients With Multiple Myeloma Previously Treated With Transplant

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT00182663·30 enrolled

Clarithromycin, Sulfamethoxazole/Trimethoprim or Observation in Newly Diagnosed Multiple Myeloma

Unknown status·HHenrik Gregersen·Phase 2·NCT02624440·300 enrolled

Ixazomib with Pomalidomide, Clarithromycin and Dexamethasone in Treating Patients with Multiple Myeloma

Active, not recruiting·JJoseph Tuscano·Phase 1/2·NCT02542657·30 enrolled

Administration of Tadalafil in Conjunction With Lenalidomide and Dexamethasone in Patients With Multiple Myeloma

Terminated·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT01374217·14 enrolled

75 more indications

Mycobacterium Avium Complex8 trials

CLArithromycin Versus AZIthromycin in the Treatment of Mycobacterium Avium Complex (MAC) Lung Infections

Recruiting·—·Phase 3·NCT03236987·424 enrolled

The Safety and Effectiveness of Clarithromycin and Rifabutin Used Alone or in Combination to Prevent Mycobacterium Avium Complex (MAC) or Disseminated MAC Disease in HIV-Infected Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00001030·1,100 enrolled

A Randomized, Double-Blind, Comparative Study of Azithromycin Versus Clarithromycin in Combination With Ethambutol for the Treatment of Disseminated Mycobacterium Avium Complex (MAC) Infection in AIDs Patients

Completed· Pfizer logo

Pfizer·Phase 3·NCT00002140

Show 5 more trials

Evaluation of Treatment for Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001039·24 enrolled

The Safety and Effectiveness of Clarithromycin Plus Zidovudine or Dideoxyinosine in the Treatment of Mycobacterium Avium Complex (MAC) Infections in Children With AIDS

Completed·AAbbott·Phase 1·NCT00000971·24 enrolled

Tolerance, Safety, and Activity of Rifapentine Alone and in Combination Therapy in AIDS Patients With Mycobacterium Avium Complex Bacteremia.

Completed·AAnderson Clinical Research·Phase 2·NCT00002192

A Comparison of Three Drug Combinations Containing Clarithromycin in the Treatment of Mycobacterium Avium Complex (MAC) Disease in Patients With AIDS

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001058·246 enrolled

The Safety and Effectiveness of Clarithromycin in the Prevention of Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients

Completed·AAbbott·N/A·NCT00002336

Fasting Conditions8 trials

To Demonstrate the Relative Bioavailability of Clarithromycin 250 mg Tablets Under Non-Fasting Conditions

Completed· Novartis logo

Novartis·Phase 1·NCT00881179·24 enrolled

To Demonstrate the Relative Bioavailability of Clarithromycin 250 mg Tablets Under Fasting Conditions

Completed· Novartis logo

Novartis·Phase 1·NCT00881738·32 enrolled

Bioequivalence Study of Clarithromycin 500mg Tablets Under Fasting Conditions.

Completed·RRanbaxy Laboratories Limited·N/A·NCT00774644·33 enrolled

Show 5 more trials

Bioequivalence Study of Clarithromycin 250mg Tablets Under Fasting Conditions

Completed·RRanbaxy Laboratories Limited·Phase 1·NCT00774189·32 enrolled

Clarithromycin 500 mg Tablets Under Non-Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT00836706·24 enrolled

Bioequivalence Study of Clarithromycin 500 mg Tablets Under Non-Fasting Conditions

Completed·RRanbaxy Laboratories Limited·N/A·NCT00774696·24 enrolled

Clarithromycin 500 mg Tablets Under Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT00835692·60 enrolled

Bioequivalency Study of Clarithromycin Tablets Under Fasting Conditions

Completed·RRoxane Laboratories·N/A·NCT00601315·40 enrolled

Tics7 trials

A Study to Assess Effects of Clarithromycin on Pharmacokinetics of JNJ-54861911 in Healthy Male Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02197884·13 enrolled

Effect of Clarithromycin on the Pharmacokinetics of Apixaban in Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT02912234·20 enrolled

Effects of Single-dose and Steady-state TPV/r on the Steady-state Pharmacokinetics of Clarithromycin and a Preliminary Assessment of the Effects of a Standard High-fat Test Meal on the Steady-state Pharmacokinetics of Tipranavir

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02251769·24 enrolled

Show 4 more trials

A Study to Investigate Effect of Clarithromycin, a Strong CYP3A4 Inhibitor, on Brensocatib Pharmacokinetics in Healthy Participants

Completed·IInsmed Incorporated·Phase 1·NCT05965570·22 enrolled

An Open-Label Study in HIV+ Patients to Determine the Effects of Nevirapine (Viramune) on the Pharmacokinetics of Clarithromycin and Activity of Cytochrome 3A4.

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT00002194·36 enrolled

Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole-Trimethoprim and Dapsone and Their Hydroxylamine Metabolites

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000826·48 enrolled

Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of After Administrations of DWP14012 Alone and Combinations of DWP14012, Clarithromycin and Amoxicillin in Healthy Male Subjects

Completed· Daewoong Pharmaceutical Co. LTD. logo

Daewoong Pharmaceutical Co. LTD.·Phase 1·NCT03487562·48 enrolled

H Pylori Infection5 trials

Efficacy and Safety of Rifasutenizol (TNP 2198), Rabeprazole and Amoxicillin in Participants With H. Pylori Infection

Completed·TTenNor Therapeutics (Suzhou) Limited·Phase 3·NCT05857163·700 enrolled

Comparison of Omeprazole vs Vonoprazon in Treatment of H Pylori Infection

Not yet recruiting·RRehman Medical Institute - RMI·Phase 4·NCT07040839·128 enrolled

Feasibility Study of the Proposed Test-and-treat Screening Program in Younger Participants With H. Pylori Infection

Unknown status·NNational Institute of Public Health, Slovenia··NCT06216639·2,000 enrolled

Show 2 more trials

High Dose Dual Therapy vs Clarithromycin Triple Therapy for Treatment Naive H Pylori Infection in an Urban Population

Completed·IIcahn School of Medicine at Mount Sinai·Phase 4·NCT05342532·112 enrolled

Furazolidone Quadruple Regimen Eradicate H. Pylori Infection

Completed·LLiaocheng People's Hospital·Phase 1/2·NCT06823791·493 enrolled

Pneumonia5 trials

Anti-inflammatory Action of Oral Clarithromycin in Community-acquired Pneumonia

Completed·HHellenic Institute for the Study of Sepsis·Phase 3·NCT04724044·278 enrolled

A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Clarithromycin Extended Release for the Treatment of Pneumonia in Adult Patients

Completed· Pfizer logo

Pfizer·Phase 3·NCT00643227·504 enrolled

Comparative Study of Ceftaroline vs. Ceftriaxone in Adult Subjects With Community-Acquired Pneumonia

Completed·FForest Laboratories·Phase 3·NCT00621504·606 enrolled

Show 2 more trials

Study Comparing the Safety and Efficacy of Cethromycin to Clarithromycin for the Treatment of Community-Acquired Pneumonia (CAP)

Completed·AAdvanced Life Sciences, Inc.·Phase 3·NCT00336505·584 enrolled

Study Comparing the Safety and Efficacy of Cethromycin to Clarithromycin for the Treatment of Community-Acquired Pneumonia

Completed·AAdvanced Life Sciences, Inc.·Phase 3·NCT00336544·522 enrolled

Efficacy4 trials

Comparison Efficacy of 14-day Concomitant Therapy:Clarithromycin vs.Levofloxacin in Eradication of H.Pylori

Withdrawn·—·Phase 4·NCT03021590

Efficacy of TAK-438, Amoxicillin and Clarithromycin in the First Line Eradication of H. Pylori

Completed· Takeda logo

Takeda·Phase 3·NCT01505127·650 enrolled

Comparison Efficacy of 14-day Triple Therapy: Clarithromycin vs. Levofloxacin on Eradication of H. Pylori

Unknown status·—·Phase 4·NCT02693574·74 enrolled

Show 1 more trial

Study to Evaluate the Preliminary Efficacy of SKB264 and the Effect of Clarithromycin on the PK of SKB264 in OC

Not yet recruiting·SSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.·Phase 2·NCT07341100·20 enrolled

Efficacy and Safety4 trials

Study to Evaluate the Efficacy and Safety of DWP14012-based Triple Therapy in Eradication of Helicobacter Pylori

Completed· Daewoong Pharmaceutical Co. LTD. logo

Daewoong Pharmaceutical Co. LTD.·Phase 3·NCT06751121·461 enrolled

Study on The Efficacy and Safety of Berberine-containing Triple Therapy in Helicobacter Pylori First-Line Eradication

Completed·XXijing Hospital of Digestive Diseases·Phase 4·NCT05014334·300 enrolled

Efficacy and Safety of Tegoprazan and Minocycline Dual Therapy for Helicobacter Pylori Initial Treatment

Active, not recruiting·XXijing Hospital of Digestive Diseases·Phase 4·NCT06523764·208 enrolled

Show 1 more trial

Study on The Efficacy and Safety of Vonoprazan-containing Berberine Triple Therapy in Helicobacter Pylori First-Line Eradication

Completed·XXijing Hospital of Digestive Diseases·Phase 4·NCT06514274·558 enrolled

Lymphoma4 trials

Antibiotic Therapy in Treating Patients With Low Grade Gastric Lymphoma

Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2·NCT00003151·96 enrolled

Pharmacokinetics Study of Oral IXAZOMIB in Participants With Advanced Nonhematologic Malignancies or Lymphoma

Completed· Takeda logo

Takeda·Phase 1·NCT01454076·112 enrolled

Helicobacter - Lymphoma - Radiation Part I: Eradication, Part II: Radiation

Unknown status·TTechnische Universität Dresden·Phase 3·NCT00154440·200 enrolled

Show 1 more trial

Chlorambucil Compared With No Further Therapy Following Anti-Helicobacter Therapy in Treating Patients With Low-Grade Lymphoma of the Stomach

Unknown status·LLymphoma Trials Office·Phase 3·NCT00003617·200 enrolled

Chronic Bronchitis3 trials

Outcome Study to Evaluate Klaricid XL® (Clarithromycin Modified Release) in Patients With Acute Exacerbation of Chronic Bronchitis

Completed·AAbbott··NCT01354938·220 enrolled

Evaluation of the Treatment With Klacid SR in Patients With Acute Tracheitis, Tracheobronchitis and Bronchitis, Acute Exacerbation of Chronic Bronchitis and Mild Community-acquired Pneumonia in Common Clinical Practice in Ukraine

Completed·AAbbott··NCT01095978·2,822 enrolled

Comparative Study of 5 Days of M02-472 Clarithromycin Extended-Release Tablets to 7 Days of Clarithromycin Immediate-Release Tablets for the Treatment of Exacerbation of Chronic Bronchitis

Completed·AAbbott·Phase 3·NCT00645086·465 enrolled

Drug Interactions3 trials

Study to Evaluate Pharmacokinetic Drug Interactions and Safety of Clarithromycin, Amoxicillin and Ilaprazole

Completed·IIl-Yang Pharm. Co., Ltd.·Phase 1·NCT02998437·28 enrolled

Drug-Drug Interactions Between TNP-2198 and Midazolam, Clarithromycin

Completed·TTenNor Therapeutics Inc.·Phase 1·NCT06551623·32 enrolled

Pharmacokinetics Study to Evaluate Drug-Drug Interactions and Safety of Elpida® in Co-Administration With Other Drugs

Completed·VViriom·Phase 1·NCT03709355·56 enrolled

Respiratory tract infection2 trials

Recovery Time in Thai Patients With Upper or Lower Respiratory Tract Infections Treated With Klacid MR

Completed·AAbbott··NCT01076153·760 enrolled

Acceptance of Clarithromycin in a Straw Compared to Syrup in Children With Upper Respiratory Tract Infections

Completed·GGrünenthal GmbH·Phase 3·NCT04016051·265 enrolled

COVID-192 trials

Clarithromycin Versus Azithromycin in Treatment of Mild COVID-19 Infection

Completed·SSouth Valley University·N/A·NCT04622891·300 enrolled

Anti-inflammatory Clarithromycin for Improving COVID-19 Infection Early

Completed·HHellenic Institute for the Study of Sepsis·Phase 2·NCT04398004·90 enrolled

Sepsis2 trials

Clarithromycin Treatment to Prevent Sepsis Progression in CAP (REACT)

Recruiting·HHellenic Institute for the Study of Sepsis·Phase 3·NCT06294600·330 enrolled

Clarithromycin as Immunomodulator for the Management of Sepsis

Completed·UUniversity of Athens·Phase 3·NCT01223690·600 enrolled

Dyspepsia2 trials

Helicobacter Pylori Eradication in Functional Dyspepsia

Completed·SSir Ganga Ram Hospital·N/A·NCT04697641·202 enrolled

Assessment and Management of Chronic Dyspepsia in Eastern Uganda

Completed·WWashington University School of Medicine·Phase 1·NCT04525664·376 enrolled

Adult2 trials

Evaluate the Effect of Clarithromycin/Rifampicin on the Pharmacokinetics of DA-8010 in Healthy Adults

Completed·DDong-A ST Co., Ltd.·Phase 1·NCT05991401·18 enrolled

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

Completed· Pfizer logo

Pfizer·Phase 1·NCT06837259·26 enrolled

Aggressive Periodontitis2 trials

Periodontal Debridement Associated With Systemic Antibiotics and Single/Repeated PDT to Treat Aggressive Periodontitis

Completed·UUniversidade Estadual Paulista Júlio de Mesquita Filho·Phase 2/3·NCT03132714·46 enrolled

Two Different Antibiotic Agents to Treat Generalized Aggressive Periodontitis

Completed·UUniversidade Estadual Paulista Júlio de Mesquita Filho·Phase 2/3·NCT02969928·46 enrolled

MPA2 trials

Comparative Bioavailability Study of Clarithromycin 250 mg Tablets

Completed· Mylan Pharmaceuticals Inc logo

Mylan Pharmaceuticals Inc·Phase 1·NCT00648830·32 enrolled

Comparative Bioavailability Study of Clarithromycin 500 mg Tablets in Fasting State

Completed· Mylan Pharmaceuticals Inc logo

Mylan Pharmaceuticals Inc·Phase 1·NCT00648960·64 enrolled

Relapsed/Refractory2 trials

Study of Decadron, Biaxin, and Pomalidomide in Relapsed/Refractory Myeloma

Completed·WWeill Medical College of Cornell University·Phase 2·NCT01159574·121 enrolled

Clarithromycin,Lenalidomide and Dexamethasone for Relapsed/Refractory Myeloma

Withdrawn·SSun Yat-sen University·Phase 2·NCT02986451

First-line Treatment2 trials

Clarithromycin Triple Therapy Plus Bismuth for Helicobacter Pylori First-line Treatment

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT02732249·66 enrolled

Efficacy and Safety of Dual Therapy as First-line Treatment for Hp Infection

Unknown status·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 4·NCT05419674·393 enrolled

Fed2 trials

Comparative Bioavailability Study of Clarithromycin 500 mg Tablets in Fed State

Completed· Mylan Pharmaceuticals Inc logo

Mylan Pharmaceuticals Inc·Phase 1·NCT00648128·44 enrolled

Bioequivalency Study of Clarithromycin Tablets Under Fed Conditions

Completed·RRoxane Laboratories·N/A·NCT00602498·28 enrolled

Cystic Fibrosis2 trials

Effect of Long Term Clarithromycin for Prevention of Exacerbations in Non-cystic Fibrosis Bronchiectasis in Asian Populations

Unknown status·—·N/A·NCT04658277·40 enrolled

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

Not yet recruiting·TThe University of Queensland·Phase 2·NCT07485010·300 enrolled

AIN2 trials

A Comparison of Clarithromycin-based and Furazolidone-based Bismuth-containing Regimens for H. Pylori Eradication

Completed·SShandong University·Phase 4·NCT03716622·350 enrolled

Efficiency Study of Clarithromycin and Bismuth-containing Quadruple Therapy to Treat H.Pylori

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT01667575·180 enrolled

PPROM1 trial

Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)

Recruiting·OOhio State University·Phase 4·NCT06396078·56 enrolled

Parkinson disease1 trial

Modulation of GABA-A Receptors in Parkinson Disease-Transdermal Flumazenil Arm

Completed·NNicolaas Bohnen, MD, PhD·Phase 1/2·NCT03440112·34 enrolled

Buruli Ulcer1 trial

WHO Drug Study for Buruli Ulcer - Comparison of SR8 and CR8

Completed·UUniversity Medical Center Groningen·Phase 2/3·NCT01659437·310 enrolled

Observational Study1 trial

Clarithromycin Modified Release Observational Study for Evaluation of Treatment, Tolerability & Recovery Time in Saudi & Egyptian Clinical Settings (CLOSER)

Completed·AAbbott··NCT01075204·335 enrolled

Second-line Treatment1 trial

Sequential Versus Quadruple Therapy in the Second-line Treatment

Unknown status·NNational Taiwan University Hospital·Phase 4·NCT03208426·240 enrolled

Resistance1 trial

Genotypic Resistance-guided Versus Empirical Therapy for H. Pylori Eradication.

Unknown status·—·Phase 4·NCT04090021·304 enrolled

Influenza1 trial

Immunomodulatory Effect of Macrolides in Naturally Occurring Influenza Virus Infections in the Community

Suspended·TThe University of Hong Kong·Phase 4·NCT03824847·100 enrolled

Oral1 trial

Bioequivaelnce Study of Clarithromycin 250 mg/5 mL Powder for Oral Suspension Under Fed Conditions

Completed·RRanbaxy Laboratories Limited·N/A·NCT00775372·40 enrolled

Infection1 trial

10 vs 14 Days Triple Therapy : H.Pylori Infection Eradication

Unknown status·IIndonesia University·Phase 4·NCT03134378·73 enrolled

Intravenous1 trial

Intravenous Clarithromycin in Septic Syndrome

Completed·UUniversity of Athens·Phase 4·NCT00297674·200 enrolled

Treatment1 trial

A Trial With Metronomic Low-dose Treosulfan, Pioglitazone and Clarithromycin Versus Standard Treatment in NSCLC

Unknown status·UUniversity Hospital Regensburg·Phase 2·NCT02852083·86 enrolled

Children1 trial

Efficacy of Nitazoxanide Based Therapy vs Standard Triple Therapy in H-pylori in Children

Completed·MMuhammad Aamir Latif·N/A·NCT07086937·66 enrolled

Esketamine1 trial

A Study to Evaluate the Absolute Bioavailability of Intranasal and Oral Esketamine and the Effects of Clarithromycin on the Pharmacokinetics of Intranasal Esketamine in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02343289·18 enrolled

ESS1 trial

Assessment of Change in CYP3A Activity by Route of Administration Using Metabolic Markers in Healthy Male Volunteers

Completed·SSeoul National University Hospital·Phase 1·NCT03366974·16 enrolled

Gastritis1 trial

Safety Trial of Herbal Melanin in Gastritis Patients

Unknown status·KKing Abdullah International Medical Research Center·Phase 2·NCT03428568·132 enrolled

Oxidative Stress1 trial

Study of the Ability of Clarithromycin to Induce Oxidative Stress

Completed·RRigshospitalet, Denmark·Phase 1·NCT00707330·26 enrolled

Mycobacterium Avium Complex Pulmonary Disease1 trial

Phase II Study of Amithiozone (Thiacetazone) for Patients With Mycobacterium Avium Complex Pulmonary Disease

Completed·NNational Jewish Health·Phase 2·NCT00004689·50 enrolled

Adenoma1 trial

Macrolides for KCNJ5 - Mutated Aldosterone-Producing Adenoma (MAPA)

Unknown status·UUniversity Hospital Padova·N/A·NCT03414918·342 enrolled

Ulcerative Colitis1 trial

Antibiotics for the Treatment of Ulcerative Colitis

Completed·UUniversity of Dundee·N/A·NCT00355602·40 enrolled

Chronic Rhinosinusitis1 trial

Efficacy of Macrolide and Glucocorticoid in the Treatment of Chronic Rhinosinusitis After Endoscopic Sinus Surgery

Completed·ZZheng Liu·N/A·NCT02182492·187 enrolled

MALT lymphoma1 trial

Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00002682·5 enrolled

Completed·CCTI BioPharma·Phase 1·NCT02807051·20 enrolled

Metformin1 trial

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

Completed·KKaken Pharmaceutical·Phase 1·NCT06227832·38 enrolled

Bronchiolitis1 trial

Use of Clarithromycin in Mustard-Induced Bronchiolitis

Completed·—·Phase 3·NCT00381147

ART1 trial

The Potential of Givinostat as DDI Victim in Co-administration P-gp Inhibitor (Part 2)

Completed· Italfarmaco logo

Italfarmaco·Phase 1·NCT05845567·20 enrolled

Encephalitis1 trial

Phase II Randomized Open-Label Trial of Atovaquone Plus Pyrimethamine and Atovaquone Plus Sulfadiazine for the Treatment of Acute Toxoplasmic Encephalitis

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000794·100 enrolled

Chronic Lung Disease1 trial

Efficacy of Clarithromycin Treatment in Prevention of Chronic Lung Disease in Premature Infants

Completed·ZZekai Tahir Burak Women's Health Research and Education Hospital·Phase 4·NCT01326611·273 enrolled

Low Birth Weight1 trial

Pharmacokinetic Study of Clarithromycin in Very Low Birth Weight (VLBW)

Terminated·SSeoul National University Hospital·Phase 2·NCT01851954·6 enrolled

Colonization1 trial

S. Aureus Decolonization in HPN Patients.

Terminated·RRadboud University Medical Center·N/A·NCT03173053·63 enrolled

Abscess1 trial

Finding the Optimal Regimen for Mycobacterium Abscessus Treatment

Recruiting·TThe University of Queensland·Phase 2/3·NCT04310930·300 enrolled

Drug1 trial

Electrophysiological Effects of Potential QT Prolonging Drugs

Completed·FFood and Drug Administration (FDA)·Phase 1·NCT05716854·44 enrolled

B-cell Malignancies1 trial

Interaction Study of Zanubrutinib With Moderate and Strong CYP3A Inhibitors in Participants With B-Cell Malignancies

Completed· BeiGene logo

BeiGene·Phase 1·NCT04551963·26 enrolled

Crohn's Disease1 trial

Clarithromycin in Active Crohn's Disease

Completed·RRoyal Liverpool University Hospital·Phase 3·NCT00269386·44 enrolled

Bismuth Quadruple Therapy1 trial

Study on the Efficacy and Safety of Berberine, Minocycline, Esomeprazole, and Colloidal Bismuth Quadruple Therapy in the Initial Treatment of Helicobacter Pylori.

Unknown status·XXijing Hospital of Digestive Diseases·Phase 4·NCT06603688·548 enrolled

Lung Cancer1 trial

Is Clarithromycin a Potential Treatment for Cachexia in People With Lung Cancer?

Terminated·UUniversity of Nottingham·Phase 2·NCT02416570·1 enrolled

Preterm Premature Rupture of Membrane1 trial

Duration of Antibiotics Treatment With Cefazolin and Clarithromycin in Women With Preterm Premature Rupture of Membrane

Completed·SSamsung Medical Center·Phase 3·NCT01503606·151 enrolled

Sinusitis1 trial

Comparative Study of the Safety and Efficacy of Clarithromycin Extended-Release Tablets Versus Amoxicillin-Clavulanate for the Treatment of Acute Bacterial Sinusitis

Completed·AAbbott·Phase 3·NCT00644553·437 enrolled

Heart Disease1 trial

The CLARICOR Trial: Effect of Clarithromycin on Mortality and Morbidity in Patients With Ischemic Heart Disease

Completed·CCopenhagen Trial Unit, Center for Clinical Intervention Research·Phase 3·NCT00121550·4,372 enrolled

Pilot Study1 trial

The Pilot Study on Tailored Eradication Therapy According to Clarithromycin Resistance in H.Pylori Patients

Completed·KKyungpook National University Hospital·Phase 4·NCT02648659·50 enrolled

Severe Infection1 trial

Benefit of Clarithromycin in Patients With Severe Infections Through Modulation of the Immune System

Completed·HHellenic Institute for the Study of Sepsis·Phase 3·NCT03345992·110 enrolled

Effectiveness1 trial

The Safety and Effectiveness of Rifabutin, Combined With Clarithromycin or Azithromycin, in HIV-Infected Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00001023·91 enrolled

Mycobacterium1 trial

Treatment of Mycobacterium Xenopi Pulmonary Infection

Completed·—·Phase 3·NCT01298336·92 enrolled

Adjuvant1 trial

Clarithromycin as Adjuvant to Periodontal Debridement

Completed·UUniversidade Estadual Paulista Júlio de Mesquita Filho·N/A·NCT02829983·40 enrolled

Homeostasis1 trial

CYP3A4 Activity and Mineral Homeostasis

Completed·UUniversity of Washington·Phase 1·NCT02019875·92 enrolled

Lung Disease1 trial

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)

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2/3·NCT04630145·129 enrolled

Asthma1 trial

Asthma Clinical Research Network (ACRN) Trial - Macrolides in Asthma (MIA)

Completed·MMilton S. Hershey Medical Center·Phase 3·NCT00318708·92 enrolled

Mycobacterium avium complex disease1 trial

Study of Four Different Treatment Approaches for Patients Who Have Mycobacterium Avium Complex Disease (MAC) Plus AIDS

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00001047·400 enrolled

Allergy1 trial

Tailored Therapy for Helicobacter Pylori Treatment in Patients With Penicillin Allergy

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT03708848·112 enrolled

Cancer1 trial

A Study of LY2835219 in Participants With Cancer

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02117648·26 enrolled

Antibiotic1 trial

Antibiotic Combination for H. Pylori Eradication in Penicillin-allergic Patients

Unknown status·SShanghai Zhongshan Hospital·Phase 4·NCT05023577·504 enrolled

Unspecified10 trials

Dexlansoprazole MR-Based Concomitant Quadruple Therapy

Completed·—·N/A·NCT03829150·202 enrolled

Clarithromycin is an Adjunct to Scaling and Root Planing

Completed·PPanineeya Mahavidyalaya Institute of Dental Sciences & Research Centre·Phase 4·NCT02359721·30 enrolled

7 Days vs. 14 Days of Vonoprazan-based Triple Therapy for H. Pylori Eradication

Completed·—·Phase 3·NCT06576882·326 enrolled

Show 7 more trials

GEM-CLARIDEX: Ld vs BiRd

Unknown status·PPETHEMA Foundation·Phase 3·NCT02575144·286 enrolled

Bioavailability of Dabigatran With or Without Clarithromycin in Healthy Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02171585·20 enrolled

Evaluation of Metabolic Markers for the Prediction of DDI of Various CYP3A Substrates and Inhibitors

Completed·SSeoul National University Hospital·Phase 1·NCT02975037·32 enrolled

Study of Levofloxacin-based Concomitant Therapy for H. Pylori Eradication in Diabetic Patients

Completed·CChung-Tai Wu·Phase 4·NCT02466919·114 enrolled

The Effect of Gemfibrozil, Ketoconazole and Clarithromycin on the Amount of LY2409021 in the Bloodstream

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01836198·30 enrolled

A Study to Evaluate the Effect of Clarithromycin on LY2216684

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01460407·14 enrolled

Cohorts of Docetaxel or Cabazitaxel in Combination With the Potent CYP3A4 Inhibitor, Clarithromycin

Terminated·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT03043989·4 enrolled

Regulatory

FDA Approval Timeline[5]

Oct 31, 1991

BIAXIN

NDA NDA050662

Dec 23, 1993

BIAXIN

NDA NDA050698

Mar 3, 2000

BIAXIN XL

NDA NDA050775

Sources

References

[1]
ClinicalTrials.gov — 214 trial records for clarithromycin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Biaxin drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — clarithromycin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for clarithromycin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA050775). U.S. Food & Drug Administration.
[6]
SEC EDGAR — AbbVie company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Bacterial 70s Ribosome Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AbbVie

Biaxin

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q3 2027

Q4 2027

Q2 2028

Trials by Indication[1]

Interaction13 trials

Helicobacter Pylori Eradication13 trials

Helicobacter Pylori13 trials

Helicobacter Pylori Infection12 trials

Multiple Myeloma12 trials

Mycobacterium Avium Complex8 trials

Fasting Conditions8 trials

Tics7 trials

H Pylori Infection5 trials

Pneumonia5 trials

Efficacy4 trials

Efficacy and Safety4 trials

Lymphoma4 trials

Chronic Bronchitis3 trials

Drug Interactions3 trials

Respiratory tract infection2 trials

COVID-192 trials

Sepsis2 trials

Dyspepsia2 trials

Adult2 trials

Aggressive Periodontitis2 trials

MPA2 trials

Relapsed/Refractory2 trials

First-line Treatment2 trials

Fed2 trials

Cystic Fibrosis2 trials

AIN2 trials

PPROM1 trial

Parkinson disease1 trial

Buruli Ulcer1 trial

Observational Study1 trial

Second-line Treatment1 trial

Resistance1 trial

Influenza1 trial

Oral1 trial

Infection1 trial

Intravenous1 trial

Treatment1 trial

Children1 trial

Esketamine1 trial

ESS1 trial

Gastritis1 trial

Oxidative Stress1 trial

Mycobacterium Avium Complex Pulmonary Disease1 trial

Adenoma1 trial

Ulcerative Colitis1 trial

Chronic Rhinosinusitis1 trial

MALT lymphoma1 trial

Infections1 trial

Safety and Efficacy1 trial

Systemic1 trial

Metformin1 trial

Bronchiolitis1 trial

ART1 trial

Encephalitis1 trial

Chronic Lung Disease1 trial

Low Birth Weight1 trial

Colonization1 trial

Abscess1 trial

Drug1 trial

B-cell Malignancies1 trial

Crohn's Disease1 trial

Bismuth Quadruple Therapy1 trial

Lung Cancer1 trial

Preterm Premature Rupture of Membrane1 trial

Sinusitis1 trial

Heart Disease1 trial

Pilot Study1 trial

Severe Infection1 trial

Effectiveness1 trial

Mycobacterium1 trial