Drugs / Clarithromycin
Clarithromycin
also known as
Biaxin · Klacid · Klaricid · CAM · CLA · CLM · 6-o-methylerythromycin · A-56268 · +37 more
Small molecule targets BCL2, CYP3A4 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 11 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | BIAXIN XL | — | 2001-08-02 – 2002-05-24 | fda.gov ↗ |
| Label expansions (8) | US (FDA) | BIAXIN | — | 1994-08-12 – 2000-10-20 | fda.gov ↗ |
| Approved | US (FDA) | BIAXIN | — | 1991-10-31 | fda.gov ↗ |
Trials 258 · started per year
today
US approved 1991
2
1
1
4
2
2
2
3
2
2
8
5
4
1
7
7
3
6
10
10
10
13
10
13
13
18
16
11
11
14
13
8
5
6
6
2
1990199119921993199419951996199719981999200020012002200320042005200620072008200920102011201220132014201520162017201820192020202120222023202420252026202720282029
News releases announcing trial results or a regulatory action · 28
| Date | Issuer | Release |
|---|---|---|
| 2026-04-30 | RedHill Biopharma Limited | Results RedHill's RHB-204 Demonstrates Comparable MAP Killing Efficacy to RHB-104 - Important Step in RHB-204 Development for MAP-related Crohn's Disease redhillbio.com ↗ |
| 2025-10-15 | HK inno.N Corporation | Results HK inno.N Presents Clinical Results of Novel GERD Drug ‘K-CAB’ for H. pylori Eradication at UEGW inno-n.com ↗
K-CAB Achieves Over 80% Eradication Rates Across All Dose Groups, Demonstrating Superior Therapeutic Efficacy |
| 2022-05-25 | RedHill Biopharma Limited | Results RedHill Presents New Talicia® Data Analyses at DDW 2022 redhillbio.com ↗
Resistance rates were 4% v 7% for amoxicillin, 45% v 43% for metronidazole, and 21% v 17% resistance to clarithromycin in patients with and without DM, respectively. |
| 2022-02-01 | Alembic Pharmaceuticals Ltd. | Regulatory 1st February, 2022, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Clarithromycin Tablets USP, 250 mg and 500 mg. |
| 2021-12-09 | RedHill Biopharma Limited | Results RedHill Biopharma: Concerning Rates of Clarithromycin Prescribing for H. pylori, Despite Increasing Antibiotic Resistance, Uncovered in New Digestive Diseases & Sciences Publication redhillbio.com ↗
This study demonstrated an approximately 60% eradication rate for clarithromycin-based therapies in treatment naïve patients2, which is consistent with recently published eradication rates3," said Dr. June Almenoff, MD, Ph.D., RedHill's Chief Medical Officer. |
| 2021-10-25 | RedHill Biopharma Limited | Results RedHill Biopharma Presents New Talicia® and Movantik® Data Analyses at ACG 2021 redhillbio.com ↗
The first Talicia analysis evaluated physician-directed therapy data, confirming high utilization of clarithromycin and low rates of H. pylori eradication. |
| 2021-01-06 | RedHill Biopharma Limited | Regulatory RedHill Biopharma's RHB-204 Granted FDA Fast Track Designation for NTM Disease redhillbio.com ↗
RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or “the Company”), a specialty biopharmaceutical company, today announced that RHB-204 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for its development as a potential first-line, stand-alone, oral treatment of pulmonary nontuberculous mycobacteria (NTM) disease caused by Mycobacterium avium Complex (MAC) – a rare disease for which there is no FDA-approved first-line therapy. |
| 2020-10-26 | RedHill Biopharma Limited | Results RedHill Biopharma Presents New Data from Talicia®’s Phase 3 Studies at ACG 2020 Focused on Achieving Successful First-Line Treatment in H. pylori Eradication redhillbio.com ↗
H. pylori eradication rates with clarithromycin-based triple therapy were found to be predictably low in the Phase 3 trial, with antibiotic resistance a contributing factor. |
| 2019-10-11 | RedHill Biopharma Limited | Results RedHill Biopharma Announces Full Results from Positive MAP US Phase 3 Study and Supportive Top-Line Results from MAP US2 Open-Label Extension Study with RHB-104 in Crohn’s Disease redhillbio.com ↗
The full Week 52 results of blinded treatment in the MAP US Phase 3 study with RHB-104 were consistent with the previously reported positive outcomes of the study. |
| 2019-10-11 | RedHill Biopharma Limited | Results RedHill Announces Full Results from MAP US Phase 3 Study and Supportive Top-Line Results from MAP US2 Study with RHB-104 in Crohn’s Disease redhillbio.com ↗
The full Week 52 results of blinded treatment in the MAP US Phase 3 study with RHB-104 were consistent with the previously reported positive outcomes of the study. |
| 2018-12-03 | RedHill Biopharma Limited | Results RedHill Biopharma Announces Positive Top-Line Results from Confirmatory Phase 3 Study with TALICIA® for H. pylori Infection redhillbio.com ↗
Preliminary H. pylori culture results taken throughout the ERADICATE Hp2 study from patients across 20 U.S. states confirmed the high resistance3 of H. pylori to the antibiotics most commonly used for treatment, clarithromycin (17% resistance) and metronidazole (43% resistance). |
| 2018-10-11 | Insmed Incorporated | Results Insmed Presents New Data at IDWeek 2018 and CHEST Annual Meeting Enhancing the Understanding of MAC Lung Disease and Treatment with ARIKAYCE® (amikacin liposome inhalation suspension) insmed.com ↗
In this oral presentation on October 8, researchers reported results from a post-hoc analysis of MAC species epidemiology, macrolide susceptibility, and relationship to culture conversion in the CONVERT study. |
| 2016-06-22 | RedHill Biopharma Limited | Results RedHill Biopharma Announces Publication Demonstrating Potential Efficacy of RHB-104 for Crohn's Disease Associated with MAP Infection redhillbio.com ↗
The results of the study demonstrated that the RHB-104 active components, in their individual concentrations or in dual combinations, were not as effective against all microorganisms, compared to the triple combination at minimum inhibitory concentrations level. |
| 2016-02-26 | Takeda | Regulatory Takeda Obtains New Drug Application Approval for Helicobacter pylori [※] Eradication triple-drug Blister Packs Containing TAKECAB tablet, "VONOSAP ® pack 400", "VONOSAP ® pack 800" and "VONOPION ® pack" in Japan takeda.com ↗
Approval was also received for “VONOPION ® pack”, a triple-drug blister pack containing “TAKECAB ® tablet” for secondary eradication of H. pylori . |
| 2016-02-26 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Takeda Obtains NDA Approval for Eradication triple-drug Blister Packs Containing TAKECAB tablet, "VONOSAP pack 400", "VONOSAP pack 800" and "VONOPION pack" in JapanHelicobacter pylori*®®® otsuka.co.jp ↗
Takeda has obtained New Drug Application approval from the Ministry of Health, Labour and Welfare for "VONOSAP pack 400", "VONOSAP pack 800" (hereafter "VONOSAP") and "VONOPION pack" (hereafter "VONOPION") for eradication. |
| 2015-03-26 | Takeda | Regulatory New Drug Application for a Single Pack Containing TAKECAB for Eradication of Helicobacter pylori in Japan takeda.com ↗ |
| 2015-03-26 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory New Drug Application for a Single Pack Containing TAKECAB for Eradication of Helicobacter pylori in Japan otsuka.co.jp ↗
Takeda has submitted an application for a single pack for the first eradication of Helicobacter pylori. |
| 2013-02-21 | Tanabe Pharma Corporation | Regulatory Helicobacter pylori Gastritis Approved as Additional Indication in Japan for Helicobacter pylori Eradication by Triple Therapy with Proton Pump Inhibitor tanabe-pharma.com ↗
Helicobacter pylori Gastritis Approved as Additional Indication in Japan for Helicobacter pylori Eradication by Triple Therapy with Proton Pump Inhibitor |
| 2013-02-21 | Kyowa Kirin, Inc. | Regulatory Pasetocin® and Sawacillin®: Approval for Additional Indication for Helicobacter pylori Eradication by Triple Therapy with Proton Pump Inhibitors and either Clarithromycin or Metronidazole kyowakirin.com ↗
has been approved by Japan's Ministry of Health, Labour and Welfare. |
| 2013-02-21 | Eisai Inc. | Regulatory Helicobacter pylori Gastritis Approved as Additional Indication in Japan for Helicobacter pylori Eradication by Triple Therapy with Proton Pump Inhibitor eisai.com ↗ |
| 2012-08-31 | Tanabe Pharma Corporation | Regulatory Companies Submit Joint Application Seeking Approval for Additional Indication for Helicobacter pylori Eradication by Concomitant Therapy with Proton Pump Inhibitors, Amoxicillin Hydrate and either Clarithromycin or Metronidazole tanabe-pharma.com ↗
Companies Submit Joint Application Seeking Approval for Additional Indication for Helicobacter pylori Eradication by Concomitant Therapy with Proton Pump Inhibitors, Amoxicillin Hydrate and either Clarithromycin or Metronidazole |
| 2012-08-31 | Kyowa Kirin, Inc. | Regulatory Pasetocin® and Sawacillin®: Joint Application Seeking Approval for Additional Indication for Helicobacter pylori Eradication by Triple Therapy with Proton Pump Inhibitors and either Clarithromycin or Metronidazole kyowakirin.com ↗
they have submitted a joint application* to Japan's Ministry of Health, Labour and Welfare seeking approval of Helicobacter pylori ("H. pylori") gastritis as an additional indication |
| 2012-08-31 | Eisai Inc. | Regulatory Companies Submit Joint Application Seeking Approval for Additional Indication for Helicobacter pylori Eradication by Concomitant Therapy with Proton Pump Inhibitors, Amoxicillin Hydrate and either Clarithromycin or Metronidazole eisai.com ↗
they have submitted a joint application * to Japan’s Ministry of Health, Labour and Welfare seeking approval of Helicobacter pylori (“ H. pylori ”) gastritis as an additional indication |
| 2010-06-18 | Tanabe Pharma Corporation | Regulatory Approval of Additional Indications for Helicobacter pylori Eradication by Concomitant Therapy with Proton Pump Inhibitors tanabe-pharma.com ↗
they have received approval from the Japanese Ministry of Health, Labor and Welfare for additional indications for Helicobacter pylori (“H. pylori”) eradication by concomitant therapy |
| 2010-06-18 | Eisai Inc. | Regulatory Approval of Additional Indications for Helicobacter pylori Eradication by Concomitant Therapy with Proton Pump Inhibitors eisai.com ↗ |
| 2009-10-01 | Eisai Inc. | Regulatory Application Submitted for Additional Indications for Helicobacter pylori Eradication by Concomitant Therapy with Proton Pump Inhibitors eisai.com ↗ |
| 2005-06-01 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval Of Clarithromycin Tablets Usp, 250 Mg And 500 Mg tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's ANDA for Clarithromycin Tablets USP, 250 mg and 500 mg. |
| 2005-05-18 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval Of Clarithromycin Er Tablets tevapharm.com ↗
Jerusalem, Israel, May 18, 2005 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's ANDA for Clarithromycin Extended Release Tablets, 500 mg. |
All press releases naming this drug 32 releases
Evidence & citations 50 cited values
Every value below carries the sentence it was read from. 462 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Clarithromycin | “Eligible patients were randomly assigned to receive intramuscular streptomycin (15 mg/kg once daily) and oral rifampicin (10 mg/kg once daily) for 8 weeks (8-week streptomycin...” PMID 20137805 ↗ Feb 2010454“Participants with positive results for infection received a standard 7-day triple therapy (esomeprazole 40 mg once daily, amoxicillin 1 g twice daily, and clarithromycin 500 mg...” PMID 16961802 ↗ Oct 2006 “Children up to 5 years: clarithromycin 15mg/kg, amoxicillin 50mg/kg, and/or furazolidone 7mg/kg Children above 8 years: doxycycline 4,4mg/kg if necessary Children able to...” NCT01730352 ↗ “14-day bismuth quadruple therapy (pantoprazole, bismuth subcitrate, tetracycline, and metronidazole for 14 days) or 14-day hybrid therapy (a 7-day dual therapy with...” PMID 28807915 ↗ Oct 2017 “Eligible patients were randomised to receive LAL: levofloxacin (750 mg once a day), amoxicillin (1000 mg twice a day) and lansoprazole (30 mg twice a day) for 7 days, or CAL:...” PMID 20427390 ↗ May 2010 “Sequential therapy comprised esomeprazole (40 mg) or tegoprazan (50 mg) plus amoxicillin (1000 mg) twice daily for the initial 5 days, followed by esomeprazole (40 mg) or...” PMID 39434634 ↗ Sep 2024 “Clarithromycin is a macrolide antibiotic used to treat pharyngitis, tonsillitis, acute maxillary sinusitis, acute bacterial exacerbation of chronic bronchitis, pneumonia...” NCT01667692 ↗ “Based on the susceptibility results and penicillin-allergic test, a tailored 7-day triple or quadruple therapy regimen is prescribed, including Tegoprazan , Amoxicillin,...” NCT07405697 ↗ “a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by...” NCT02547038 ↗ “Group 1: (110) participants received reverse hybrid regimen in the form of clarithromycin 500mg bid, omeprazole 20 mg bid, amoxicillin 1gm bid, and metronidazole 500 mg tid for...” NCT04039412 ↗ “Treatment for H. pylori Patients with positive Urea Breath Test (positive for H. pylori infection) will be started on eradication therapy of H. pylori (oral esomeprazole 40mg...” NCT02112812 ↗ |
| Known as | 6-o-methylerythromycin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1741 ↗ |
| Known as | A-56268 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1741 ↗ |
| Known as | ABBOTT-56268 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1741 ↗ |
| Known as | Biaxin | “The study was conducted as an open label, balanced, randomised, two-treatment, four-period, two-sequence, single-dose, crossover fully replicated, bioavailability study on...” NCT00775372 ↗7“Clarithromycin 500 mg Tablet (test) dosed in first period followed by Biaxin® 500 mg Tablet (reference) dosed in second period” NCT00835692 ↗ “Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day beginning on day 2 of cycle 1.” NCT00151203 ↗ “Biaxin (Clarithromycin) 250 mg Tablets (Abbott Laboratories, Inc, USA)” NCT00881179 ↗ “Biaxin® (Clarithromycin) 250 mg tablet” NCT00648830 ↗ “Clarithromycin (BIAXIN®) 500 mg Bid” NCT02251769 ↗ “Clarithromycin (BIAXIN®)” NCT00538733 ↗ “Biaxin ( clarithromycin)” NCT00205634 ↗ |
| Known as | Biaxin Filmtabs | “Biaxin®, Biaxin® Filmtabs” NCT00648830 ↗ |
| Known as | Biaxin xl | ChEMBL registry synonym — accepted as the source's own label CHEMBL1741 ↗ |
| Known as | Biaxin xl pac | ChEMBL registry synonym — accepted as the source's own label CHEMBL1741 ↗ |
| Known as | CAM | “Most patients who have failed in the eradication of H. pylori infection by triple therapy with a PPI, amoxicillin (AMPC) and clarithromycin (CAM) at standard doses have...” NCT00197418 ↗2“The purpose of the study is to evaluate the efficacy of bedaquiline (BDQ) compared with rifamycin when administered as part of a treatment regimen with clarithromycin (CAM) and...” NCT04630145 ↗ “second line immune-modulator regimens (CAMC, clarithromycin (CAM) and low-dose cyclophosphamide) will be prescribed” NCT07144657 ↗ |
| Known as | CASnr 81103-11-9 | “CASnr 81103-11-9” NCT01207739 ↗ |
| Known as | CLA | “CLA (clarithromycin) at the same dose and on the same days as the patient's lenalidomide-containing treatment (it varies for each subject).” NCT02188368 ↗2“WHO-recommended treatment requires 8-weeks of daily rifampicin (RIF) and clarithromycin (CLA) with wound care.” PMID 38573915 ↗ Apr 2024 “In Group A: Amoxicillin AMO + Clarithromycin CLA + Proton pump inhibitor PPI will be given to children” NCT04721704 ↗ |
| Known as | Clarie xl | ChEMBL registry synonym — accepted as the source's own label CHEMBL1741 ↗ |
| Known as | Clarithro | “Clarithro -pantoprazole- Metronidazole - Amoxicyllin” NCT06050824 ↗ |
| Known as | Clarithromycin component of prevpac | ChEMBL registry synonym — accepted as the source's own label CHEMBL1741 ↗ |
| Known as | Clarithromycin extended release | ChEMBL registry synonym — accepted as the source's own label CHEMBL1741 ↗ |
| Known as | Clarithromycin identity | ChEMBL registry synonym — accepted as the source's own label CHEMBL1741 ↗ |
| Known as | clarithromycin or Klacid | “clarithromycin or Klacid” NCT00467571 ↗ |
| Known as | Clarithromycin S/R (Klaricid XL) | “Clarithromycin S/R (Klaricid XL)” NCT00269386 ↗ |
| Known as | Clarithromycin XL | “Clarithromycin XL administered once daily on Days 4 through 9 as 2 x 500 mg tablets, 1000 mg per day, for a total of 6000 mg” NCT02080780 ↗ |
| Known as | Clarithromycin, 250/500mg (Pharmachemie) RVG 029081/029082 | “Clarithromycin, 250/500mg (Pharmachemie) RVG 029081/029082” NCT01521364 ↗ |
| Known as | Clarithromycin: Klacid | “Clarithromycin: Klacid” NCT01219764 ↗ |
| Known as | Clarithromycine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1741 ↗ |
| Known as | Clarithromycine Mylan, RVG 32619 | “Clarithromycine Mylan, RVG 32619” NCT01207739 ↗ |
| Known as | Claritromicina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1741 ↗ |
| Known as | Clarosip | ChEMBL registry synonym — accepted as the source's own label CHEMBL1741 ↗ |
| Known as | CLM | “The aim of the present study is to evaluate the periodontal clinical and microbiologic responses and possible adverse effects of clarithromycin (CLM) combined with periodontal...” PMID 28671507 ↗ Jul 20172“This study aims to identify if clarithromycin (CLM) has potential as a widely available and inexpensive treatment for cachexia” NCT02416570 ↗ “clarithromycin (CLM) as adjuncts to one-stage full-mouth ultrasonic debridement” PMID 31257591 ↗ Jul 2019 |
| Known as | Clr-Clarithromycin | “The candidated drugs to be selected are:Cs-Cycloserine,Pto-Protionamide,Clr-Clarithromycin,PAS-sodium para-aminosalicylate,E-ethambutol,Bdq-Bedaquiline,Cfz-Clofazimine,Lzd-linezolid” NCT03830671 ↗ |
| Known as | Cyllind | ChEMBL registry synonym — accepted as the source's own label CHEMBL1741 ↗ |
| Known as | Febzin xl | ChEMBL registry synonym — accepted as the source's own label CHEMBL1741 ↗ |
| Known as | Klacid | “Clarithromycin (Klacid) 500mg bid for last 5 days” NCT01760824 ↗5“Clarithromycin (Klacid, Abbott S.r.l) 500mg bid” NCT05049902 ↗ “Clarithromycin (Klacid, Abbott S.r.l) 500mg bid” NCT04901117 ↗ “clarithromycin (Klacid) 500mg po bid for 14d” NCT03716622 ↗ “clarithromycin (Klacid) 250mg po bid” NCT04101708 ↗ |
| Known as | Klaricid | “Clarithromycin(Klaricid), Amoxicillin(Hiconcil) and” NCT01575899 ↗4“clarithromycin, klaricid® 500mg bid 5 days (D6-D10)” NCT02373280 ↗ “1. Klaricid, 500 mg, bid” NCT01032655 ↗ |
| Known as | Klaricid 500 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1741 ↗ |
| Known as | Klaricid adult | ChEMBL registry synonym — accepted as the source's own label CHEMBL1741 ↗ |
| Known as | Klaricid i.v. | ChEMBL registry synonym — accepted as the source's own label CHEMBL1741 ↗ |
| Known as | Klaricid paed | ChEMBL registry synonym — accepted as the source's own label CHEMBL1741 ↗ |
| Known as | Klaricid-XL | “Klaricid-XL, clarithromycin, 500mg, bid, for 7 days, (day 8-14)” NCT03208426 ↗ |
| Known as | Macladin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1741 ↗ |
| Known as | Makcin | “Clarithromycin ('Makcin') 500 mg bid for 14 days” NCT03572777 ↗ |
| Known as | Mavid | ChEMBL registry synonym — accepted as the source's own label CHEMBL1741 ↗ |
| Known as | Mycifor xl | ChEMBL registry synonym — accepted as the source's own label CHEMBL1741 ↗ |
| Known as | Naxy | ChEMBL registry synonym — accepted as the source's own label CHEMBL1741 ↗ |
| Known as | NSC-758704 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1741 ↗ |
| Known as | TE-031 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1741 ↗ |
| Known as | Veclam | ChEMBL registry synonym — accepted as the source's own label CHEMBL1741 ↗ |
| Known as | Xetinin xl | ChEMBL registry synonym — accepted as the source's own label CHEMBL1741 ↗ |
| Known as | Zeclar | “Clarithromycin (Zeclar) 500 mg” NCT01385683 ↗ |
| Action | Inhibit | “Clarithromycin is a potent inhibitor of the activity of cytochrome P450 (CYP) 3A4” NCT00984061 ↗ |
| Modality | Small molecule | “Clarithromycin, a new macrolide antimicrobial agent, has demonstrated activity against MAC both in the laboratory and in animals.” NCT00000644 ↗ |
| Route | Oral | “clarithromycin given orally at 1 of 3 doses” NCT00000644 ↗ |
| Target | CYP3A4 | “Clarithromycin is a potent inhibitor of the activity of cytochrome P450 (CYP) 3A4” NCT00984061 ↗ |