Drugs / Amoxicillin
Amoxicillin
also known as
Amoxycillin · Amoxil · AMX · Amoxicilline · Amoxicillin Trihydrate · A Mo Xian · AMO · Amoksicilin · +16 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
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| Label expansion | US (FDA) | AMOXIL | — | 1998-02-27 | fda.gov ↗ |
| Approved | US (FDA) | AMOXIL | — | 1974-01-18 | fda.gov ↗ |
Trials 370 · started per year
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News releases announcing trial results or a regulatory action · 39
| Date | Issuer | Release |
|---|---|---|
| 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 |
| 2025-06-25 | Iterum Therapeutics, International Limited | Results Iterum Therapeutics Announces Publication of REASSURE Trial in NEJM Evidence iterumtx.com ↗
“We are very pleased that NEJM Evidence have published the results from the REASSURE trial,” said Corey Fishman, Iterum’s Chief Executive Officer. |
| 2024-01-30 | Iterum Therapeutics, International Limited | Results Iterum Therapeutics Announces Positive Topline Results from its Phase 3 REASSURE Clinical Trial of Oral Sulopenem in Uncomplicated Urinary Tract Infections iterumtx.com ↗ |
| 2023-09-18 | RedHill Biopharma Limited | Regulatory RedHill Announces FDA sNDA Approval for Talicia® redhillbio.com ↗
RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, announced the U.S. Food and Drug Administration's (FDA) approval of its supplemental new drug application (sNDA) for Talicia[3], allowing a change to a more flexible three times daily (TID), taken at least 4 hours apart with food, dosing regimen for H. pylori eradication. |
| 2023-08-01 | RedHill Biopharma Limited | Regulatory RedHill Biopharma Announces Talicia Approved in the United Arab Emirates and First Commercial Order Outside the U.S. redhillbio.com ↗
RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, announced that its partner, Gaelan Medical LLC ("Gaelan Medical"), a wholly owned subsidiary of the Ghassan Aboud Group (GAG), has received marketing approval from the United Arab Emirates (UAE) Ministry of Health for Talicia (omeprazole magnesium, amoxicillin and rifabutin)[3]. |
| 2023-05-09 | RedHill Biopharma Limited | Results RedHill Publishes New Talicia® Data on Generic Non-Bioequivalence in AP&T and Presents New Dosing Data at Digestive Disease Week redhillbio.com ↗
The PBPK modeling data we have presented supports bioequivalence between Talicia TID and Q8H dosing regimens for H. pylori eradication therapy showing that the overall exposures are comparable for all three Talicia-containing drugs, amoxicillin, rifabutin, and omeprazole. |
| 2022-07-12 | RedHill Biopharma Limited | Results RedHill Announces New H. pylori and COVID-19 Data Publication and Presentations at Leading Upcoming Scientific Conferences redhillbio.com ↗
Helicobacter pylori Eradication by Low-Dose Rifabutin Triple Therapy (Talicia®) is Unaffected by High Body Mass Index |
| 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. |
| 2021-12-02 | RedHill Biopharma Limited | Results RedHill Biopharma Data Published in GastroHep Shows Consistent Efficacy of Talicia Irrespective of Patient BMI redhillbio.com ↗
Talicia maintained high efficacy across all BMI groups compared to the active comparator including in obese and severely obese patients (P<0.0001). |
| 2021-10-25 | RedHill Biopharma Limited | Results RedHill Biopharma Presents New Talicia® and Movantik® Data Analyses at ACG 2021 redhillbio.com ↗
today announced the presentation of four new analyses of Phase 3 Talicia® (omeprazole magnesium, amoxicillin and rifabutin)1 and Movantik® (naloxegol)2 data at the ACG 2021 Annual Scientific Meeting, taking place October 22-27, 2021. |
| 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 ↗
This maintenance of Talicia efficacy compares to an almost 50% reduction of eradication rates in amoxicillin/omeprazole-comparator-treated patients with BMI ≥40. |
| 2020-05-05 | RedHill Biopharma Limited | Results RedHill Biopharma Announces Publication of Talicia® Pivotal Phase 3 Study Results in Annals of Internal Medicine redhillbio.com ↗
Results demonstrated the added rifabutin benefit with 83.8% eradication of H. pylori infection with Talicia vs. 57.7% in the active comparator arm (ITT analysis, p<0.0001), showing a 26.1% benefit with Talicia. |
| 2019-11-04 | RedHill Biopharma Limited | Regulatory RedHill Biopharma Announces FDA Approval of Talicia® for Treatment of H. pylori in Adults redhillbio.com ↗ |
| 2019-10-28 | RedHill Biopharma Limited | Results RedHill Biopharma to Present New Phase 3 Data on RHB-105 and RHB-104 at the American College of Gastroenterology 2019 Annual Meeting redhillbio.com ↗
The abstract discusses the positive Phase 3 ERADICATE Hp2 study results, concluding that RHB-105 (Talicia) was found to be safe, effective and well-tolerated in H. pylori eradication, and not affected by clarithromycin or metronidazole resistance. |
| 2019-07-03 | RedHill Biopharma Limited | Regulatory RedHill Biopharma Announces FDA Acceptance of New Drug Application for Talicia® redhillbio.com ↗
RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on gastrointestinal diseases, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Talicia® (RHB-105)1 for H. pylori infection. |
| 2019-05-07 | RedHill Biopharma Limited | Regulatory RedHill Biopharma Submits New Drug Application for Talicia® for H. pylori Infection redhillbio.com ↗
The NDA was submitted under the 505(b)(2) regulatory pathway. |
| 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 ↗
The ERADICATE Hp2 study successfully met its primary endpoint with a high degree of statistical significance, demonstrating 84% eradication of H. pylori infection with TALICIA® versus 58% in the active comparator arm in the intent-to-treat (ITT) population (p<0.0001). |
| 2017-05-04 | RedHill Biopharma Limited | Results RedHill Biopharma Announces Poster Presentation of the Positive RHB-105 Phase III Results for H. pylori Infection at Digestive Disease Week 2017 redhillbio.com ↗
The study results demonstrated 89.4% efficacy in eradicating H. pylori infection with RHB-105. |
| 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 ↗ |
| 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 ↗ |
| 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 | 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 ↗
announced today that 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 for H. pylori eradication |
| 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 ↗
This concomitant therapy consists of a proton pump inhibitor, amoxicillin hydrate, and either clarithromycin or metronidazole, and is indicated for the eradication of H. pylori in gastric MALT lymphoma (*1), idiopathic thrombocytopenic purpura (*2) (“ITP”) and the stomach after endoscopic resection of early stage gastric cancer. |
| 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 ↗ |
| 2008-12-04 | Wockhardt | Regulatory Wockhardt receives US FDA approval for generic version of Augmentin* Suspension wockhardt.com ↗
Wockhardt’s Chicago based subsidiary Morton Grove Pharmaceuticals received approval from the US FDA for marketing the suspension containing 250 mg/ 5ml of Amoxycillin and 62.5mg/ 5ml of Clavulanate potassium, which is used for treating several common infections, especially in children. |
| 2005-02-10 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval Of Amoxicillin And Clavulanate Potassium Chewable Tablets 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 Amoxicillin and Clavulanate Potassium Chewable Tablets USP, 200 mg/28.5 mg and 400 mg/57 mg. |
| 2004-05-25 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval Of Amoxicillin And Clavulanate Potassium For Oral Suspension, 200 mg and 400 mg tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted approval for the company's ANDA for Amoxicillin and Clavulanate Potassium for Oral Suspension, 200 mg/28.5 mg/5 mL and 400 mg/57 mg/5 mL. |
| 2002-12-05 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval of Amoxicillin for Oral Suspension tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U. S. Food and Drug Administration has approved the company's ANDA for Amoxicillin for Oral Suspension (BID), 200 mg/5 mL and 400 mg/5 mL. |
| 2002-10-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval of Generic Version of Augmentin® tevapharm.com ↗ |
| 2002-10-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval of 500mg/125mg Strength of Generic Version of Augmentin® tevapharm.com ↗
Further to announcements made earlier in the day, Teva announced the receipt of U.S. Food and Drug Administration approval of its ANDA for Amoxicillin and Clavulanate Potassium Tablets, the generic version of GlaxoSmithKline's Augmentin® 500mg/125mg. |
| 2002-03-13 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Federal Judge Invalidates Augmentin Patents tevapharm.com ↗
Teva Pharmaceutical Industries, Ltd. (Nasdaq: TEVA) announced today that a federal judge has ruled in its favor, invalidating three GlaxoSmithKline patents, otherwise due to expire in 2017, covering the antibiotic Augmentin. |
| 2001-12-17 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Final Approval of Lovastatin Tablets tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that it has received final FDA approval of its Abbreviated New Drug Application (ANDA) for Lovastatin Tablets 10, 20 and 40 mg, following the expiration of Merck's period of pediatric exclusivity for Mevacor. |
| 2000-09-19 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Receives First Generic Approval for Amoxicillin 500 and 875 mg Tablets tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that it has received from the U.S. FDA final approval to manufacture and market Amoxicillin 500 and 875 mg Tablets, intended for twice-daily dosage. |
All press releases naming this drug 40 releases
Evidence & citations 28 cited values
Every value below carries the sentence it was read from. 717 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Amoxicillin | “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 2006690“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 “A is amoxicillin (1000 mg thrice daily), B is colloidal bismuth subcitrate (120 mg thrice daily), M is metronidazole (500 mg thrice daily), P is a proton pump inhibitor, i.e.,...” NCT06687473 ↗ “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 “patients in the control group will receive a prescription for amoxicillin 500 milligrams (mg) (three times daily for 7 days), while patients in the intervention group will...” NCT05266040 ↗ “with initiation of antibiotic therapy at day 1 with Amoxicillin/clavulanic acid IntraVeinous (IV) in 2 doses daily for a minimum of 24 hours and a maximum of 48 hours with a...” NCT07587450 ↗ “A 3-day course of oral amoxicillin (500 mg three times per day) or trimethoprim/sulfamethoxazole in penicillin-allergic patients (160 mg trimethoprim / 800mg sulfamethoxazole...” NCT01967758 ↗ “Based on the susceptibility results and penicillin-allergic test, a tailored 7-day triple or quadruple therapy regimen is prescribed, including Tegoprazan , Amoxicillin,...” NCT07405697 ↗ “The antibiotics that were chosen (efficient for urinary tract infection, well tolerated, low selection pressure) included : Amoxicillin 6000 mg, Amoxicillin/clavulanic acid...” NCT01388413 ↗ “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 ↗ |
| Known as | A Mo Xian | “amoxicillin granules (A Mo Xian)” NCT04034641 ↗ |
| Known as | AMO | “In Group A: Amoxicillin AMO + Clarithromycin CLA + Proton pump inhibitor PPI will be given to children” NCT04721704 ↗ |
| Known as | Amoksicilin | “Amoxicillin ('Amoksicilin') 1 g bid 14 days.” NCT03572777 ↗ |
| Known as | Amoksicillintrihydrat | “Amoxicillin (Amoksicillintrihydrat)” NCT02323412 ↗ |
| Known as | AMOX | “Amoxicillin (AMOX) is a broad spectrum antibiotic and was prescribed at 500 mg tid for 14d.” NCT00066066 ↗ |
| Known as | Amoxicillin (generic drug) | “Amoxicillin (generic drug)” NCT02783404 ↗ |
| Known as | Amoxicillin (Hiconcil) | “Amoxicillin (Hiconcil)” NCT05655338 ↗ |
| Known as | amoxicillin / clav. acid | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00818610 ↗ |
| Known as | Amoxicillin Trihydrate | “co-amoxiclav is a combination antibiotic consisting of amoxicillin trihydrate, a β-lactam antibiotic, and potassium clavulanate, a β-lactamase inhibitor” NCT01870167 ↗1“Amoxicillin (Amoxicillin Trihydrate), 1gm, bid, 7 days” NCT01725906 ↗ |
| Known as | Amoxicillin/CA | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06532409 ↗ |
| Known as | Amoxicillin/clavulunate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01370616 ↗ |
| Known as | Amoxicillin/clavulunate potassium | “participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28” NCT01370616 ↗ |
| Known as | Amoxicillin: Amoxil | “Amoxicillin: Amoxil” NCT01219764 ↗ |
| Known as | Amoxicilline | “omeprazole 2x1) + clarithromycin 2x500 mg + amoxicilline 2x1000 mg + Bismuth Subsalicylate 2x1” NCT03757650 ↗ |
| Known as | Amoxicilline Sandoz | “Drug: 3/d 500 mg Amoxicilline Sandoz plus 500 mg Flagyl for 7 days” NCT04669717 ↗ |
| Known as | Amoxicyllin | “Clarithro -pantoprazole- Metronidazole - Amoxicyllin” NCT06050824 ↗ |
| Known as | Amoxil | “Each subject will received oral Amoxicillin/Amoxil/lansoprazole/Flagyl 250 mg of each three times a day for 8 days.” NCT01568944 ↗ |
| Known as | Amoxycillin | “Qingre Huashi Granules 1 package twice daily, Rabeprazole 20mg triple daily, Amoxycillin 1g triple daily.” NCT05364619 ↗14“PO Amoxycillin 50mg per Kg divided by 3 (up to 500mg 3 times a day) - for 3 weeks” NCT02033408 ↗ “Amoxycillin 1gm twice a day (BD) Clarithromycin 500mg BD Omeprazole 20mg BD” NCT02108704 ↗ “Omeprazole, amoxycillin, clarithromycin” NCT03491995 ↗ “amoxycillin 1 gm twice daily” NCT06101420 ↗ |
| Known as | Amoxycillin or Ibiamox | “Amoxycillin or Ibiamox” NCT00467571 ↗ |
| Known as | AMPC | “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 ↗ |
| Known as | AMX | “The primary objective of this study is to demonstrate the non-inferiority, at the assessment visit (V3 (D10/D14)), in terms of bacteriological efficacy of pristinamycin (PRI)...” NCT00393744 ↗4“The benefits of amoxicillin (AMX) plus metronidazole (MTZ) adjunctive to scaling and root planing (SRP) require further investigation, particularly in individuals with a high...” NCT05934227 ↗ “MTZ + amoxicillin (AMX) in the treatment of generalized chronic periodontitis (ChP).” PMID 23016867 ↗ Sep 2012 “amoxicillin + metronidazole (AMX + MET) versus clarithromycin (CLM)” PMID 31257591 ↗ Jul 2019 “combined with systemic metronidazole (MTZ) and amoxicillin (AMX).” PMID 27013640 ↗ Mar 2016 |
| Known as | Antibiotics, Amoxicillin ,Amoxicillin | “Antibiotics, Amoxicillin ,Amoxicillin®” NCT03897244 ↗ |
| Known as | Clamoxyl | “Amoxicillin (Clamoxyl) pediatric formulation (500 mg/5 ml) administered as an oral suspension at a dose of 25 mg/kg twice daily (maximal dose 2 g/day) for 6 consecutive days” NCT00643539 ↗ |
| Known as | Hiconcil | “Clarithromycin(Klaricid), Amoxicillin(Hiconcil) and” NCT01575899 ↗ |
| Action | Inhibit | “Amoxicillin is a beta-lactam antibiotic that inhibits cell wall synthesis of actively replicating cells” NCT06088316 ↗ |
| Modality | Other / unclassified | “Beta-lactam antibiotic” NCT00716183 ↗ |
| Route | Oral | “orally administered antibiotics metronidazole and amoxicillin” NCT00066066 ↗ |