Drugs / Fexofenadine
Fexofenadine
also known as
Allegra · Fexofenadine Hydrochloride · fexofenadine HCl · M016455 · Telfast · OP2101 · Zentiva
targets TNF via inhibition
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | ALLEGRA HIVES | — | 2003-05-12 – 2011-01-24 | fda.gov ↗ |
| Approved | US (FDA) | ALLEGRA | — | 1996-07-25 | fda.gov ↗ |
Trials 66 · started per year
today
US approved 1996
10
7
1
1
2
1
1
4
2
2
1
5
3
1
4
2
2
2
1
4
4
6
19961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04534153 | Jan 2023 → Jun 2025 | — | University of California, San Francisco | Completed | No outcome recorded |
| Phase 119 trials · 1 met primary | ||||||
| Phase 1 | NCT07118215 | Sep 2025 → Jun 2026 overdue | — | Karuna Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT06284902 | Feb → May 2024 | — | Opella Healthcare Group SAS | Completed | No outcome recorded |
| Phase 1 | NCT06205381 | Jan 2024 → Feb 2025 | — | Aeovian Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05932277 | Jun → Sep 2023 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT05461456 | Apr → Oct 2022 | atopic eczema, chronic urticaria, exanthem, psoriasis | OrchestratePharma GmbH | Completed | No outcome recorded |
| Phase 1 | NCT03183297 | Aug → Oct 2017 | — | Sen-Jam Pharmaceutical | Unknown | No outcome recorded |
| Phase 1 | NCT03108274 | Apr → Jun 2017 | — | Alexion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02908750 | Mar → Jul 2017 | non-small cell lung carcinoma | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT02592317 | Feb → Nov 2016 overdue | castration-resistant prostate carcinoma | Aragon Pharmaceuticals, Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02391688 | Nov 2014 → Apr 2015 | — | Jules Desmeules | Completed | No outcome recorded |
| Phase 1 | NCT02157558 | Jul → Aug 2014 | — | Lexicon Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02056743 | Sep → Oct 2013 | — | Chonbuk National University Hospital | Completed | No outcome recorded |
| Phase 1 | NCT01731067 | Nov 2012 → May 2013 | — | Jules Desmeules | Completed | No outcome recorded |
| Phase 1 | NCT02966665 | Sep 2008 → Aug 2030 expected | chronic obstructive pulmonary disease, heart failure, pulmonary arterial hypertension | D. Walter Wray | Recruiting | No outcome recorded |
| Phase 1 | NCT02171546 | Nov 2007 → Jan 2008 | — | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 1 | NCT00647985 | Nov 2003 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1 | NCT00649376 | Oct → Nov 2003 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1 | NCT00835276 | Mar 2002 | — | Teva Pharmaceuticals USA | Completed | Met primary |
| Phase 1 | NCT00835640 | Jan 2002 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT07487909 | Sep → Nov 2025 | — | Sen-Jam Pharmaceutical | Completed | No outcome recorded |
| Phase 25 trials · 3 missed | ||||||
| Phase 2 | NCT06548204 | Jan 2025 → Dec 2026 expected | ST-elevation myocardial infarction | Second Affiliated Hospital, Zhejiang University, School of Medicine | Recruiting | No outcome recorded |
| Phase 2 | NCT04726345 | Jun 2021 → Jun 2024 | nephrolithiasis | Columbia University | Completed | Missed primary |
| Phase 2 | NCT03425097 | Feb 2018 → Jan 2019 | gastroesophageal reflux disease | Stanford University | Terminated | No outcome recorded |
| Phase 2 | NCT01172522 | Sep → Dec 2010 | — | The Connecticut Sinus Center, PC | Completed | Missed primary |
| Phase 2 | NCT01033396 | Jan → May 2010 | allergic rhinitis | Pfizer | Completed | Missed primary |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT01244230 | Nov 2010 → Jul 2011 | atopic eczema | Sanofi | Completed | No outcome recorded |
| Phase 2/3 | NCT01244217 | Oct 2010 → Jul 2011 | perennial allergic rhinitis | Sanofi | Completed | No outcome recorded |
| Phase 39 trials · 1 met primary | ||||||
| Phase 3 | NCT05118672 | Mar → Aug 2025 | influenza | Eurofarma Laboratorios S.A. | Completed | No outcome recorded |
| Phase 3 | NCT07381803 | Jan 2025 → Dec 2026 expected | — | Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | No outcome recorded |
| Phase 3 | NCT05692154 | Jan → Mar 2023 | seasonal allergic rhinitis | Opella Healthcare Group SAS | Completed | Met primary |
| Phase 3 | NCT03664882 | Sep 2018 → Jan 2019 | seasonal allergic rhinitis | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT02401191 | Mar → Jul 2015 | allergic rhinitis | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT01306721 | Feb → Apr 2011 | seasonal allergic rhinitis | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT00044811 | Mar 2002 → Oct 2003 | asthma | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT00045955 | Feb 2002 → Nov 2003 | asthma | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT00044824 | Feb 2002 → Oct 2003 | asthma | Sanofi | Completed | No outcome recorded |
| Phase 420 trials · 2 met primary | ||||||
| Phase 4 | NCT05720455 | Jun → Dec 2025 | allergic rhinitis | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT06466421 | Jul → Oct 2024 | end stage renal failure | Tanta University | Completed | No outcome recorded |
| Phase 4 | NCT03933007 | Sep → Oct 2019 | gout | Assistance Publique - Hôpitaux de Paris | Terminated | No outcome recorded |
| Phase 4 | NCT03078777 | Nov 2017 → Aug 2020 | — | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Unknown | No outcome recorded |
| Phase 4 | NCT02175485 | Jun 2014 | allergic rhinitis | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT02551536 | Apr 2014 → Apr 2015 | allergic rhinitis | Indira Gandhi Medical College, Shimla | Completed | No outcome recorded |
| Phase 4 | NCT01469234 | Oct → Nov 2011 | rhinitis | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT00502775 | Aug → Nov 2007 | seasonal allergic rhinitis | GlaxoSmithKline | Completed | Met primary |
| Phase 4 | NCT00435461 | Dec 2006 → Feb 2007 | seasonal allergic rhinitis | GlaxoSmithKline | Completed | Met primary |
| Phase 4 | NCT00261079 | Apr 2005 → Oct 2006 | — | Handok Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00637884 | Nov 2003 → Feb 2004 | allergic rhinitis | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT00637455 | Sep 2003 → Jan 2005 | seasonal allergic rhinitis | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT00636870 | Feb 2003 → Jan 2004 | allergic rhinitis | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT00637611 | Feb → Apr 2003 | seasonal allergic rhinitis | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT00638118 | Feb → May 2003 | allergic rhinitis | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT00637585 | Dec 2002 → Jul 2003 | allergic rhinitis | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT00783133 | Nov 2002 → Jun 2003 | seasonal allergic rhinitis | Organon and Co | Completed | No outcome recorded |
| Phase 4 | NCT00794768 | Nov 2002 → Jul 2003 | seasonal allergic rhinitis | Organon and Co | Completed | No outcome recorded |
| Phase 4 | NCT00794248 | Nov 2002 → May 2003 | seasonal allergic rhinitis | Organon and Co | Completed | No outcome recorded |
| Phase 4 | NCT00741897 | Mar 2002 → Dec 2003 | perennial allergic rhinitis | Sanofi | Completed | No outcome recorded |
| Phase not applicable9 trials · 1 missed | ||||||
| — | NCT06629337 | Apr → Aug 2024 | hypertensive disorder | California Baptist University | Completed | No outcome recorded |
| — | NCT06152497 | Sep 2023 → Dec 2026 expected | — | University Ghent | Recruiting | No outcome recorded |
| — | NCT05131555 | Aug → Dec 2021 | — | University Ghent | Completed | No outcome recorded |
| — | NCT04450134 | Oct → Dec 2019 | — | University Ghent | Completed | No outcome recorded |
| — | NCT02590185 | Dec 2015 → Dec 2019 | major depressive disorder | Assistance Publique - Hôpitaux de Paris | Unknown | No outcome recorded |
| — | NCT02789527 | Nov 2015 → Apr 2017 | — | Estella S. Poloni | Completed | No outcome recorded |
| — | NCT02438072 | Dec 2014 → Dec 2015 | depressive disorder | University Hospital, Geneva | Unknown | No outcome recorded |
| — | NCT01767272 | Dec 2012 → Jan 2013 | — | Damanhour University | Completed | No outcome recorded |
| — | NCT01526213 | Sep 2009 → Apr 2010 | — | University of North Carolina, Chapel Hill | Completed | Missed primary |
| Comparator or background therapy21 trials | ||||||
| Phase 1 | NCT04568902 Background | Sep 2020 → Oct 2025 | breast cancer | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03012763 Comparator | Apr 2016 → Jan 2017 | — | University Medicine Greifswald | Completed | No outcome recorded |
| Phase 1 | NCT01298505 Background | Jun 2010 | — | Pfizer | Terminated | No outcome recorded |
| Phase 1/2 | NCT05264025 Comparator | Jun 2022 → Dec 2025 overdue | rheumatoid arthritis | October 6 University | Recruiting | No outcome recorded |
| Phase 2 | NCT07526558 Background | Apr 2026 → Jan 2027 expected | tick-borne infectious disease | University of North Carolina, Chapel Hill | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT01683552 Background | Sep 2010 → Nov 2011 | — | Campus-Bio-Medico University | Completed | No outcome recorded |
| Phase 2 | NCT00866788 Background | Mar 2009 → Jan 2010 | chronic idiopathic urticaria | Genentech, Inc. | Completed | Met primary |
| Phase 2 | NCT00562120 Comparator | Dec 2007 → Aug 2008 | allergic rhinitis | Pfizer | Completed | Missed primary |
| Phase 2 | NCT00420082 Comparator | Oct → Dec 2006 | seasonal allergic rhinitis | Faes Farma, S.A. | Completed | No outcome recorded |
| Phase 2/3 | NCT06785298 Comparator | Dec 2024 → Dec 2026 expected | Parkinson disease | Tanta University | Recruiting | No outcome recorded |
| Phase 3 | NCT05263206 Background | Feb 2022 → Jun 2027 expected | — | Sanofi | Recruiting | No outcome recorded |
| Phase 3 | NCT04688788 Background | Apr 2021 → Jun 2026 overdue | primary progressive multiple sclerosis, relapsing-remitting multiple sclerosis, secondary progressive multiple sclerosis | Rigshospitalet, Denmark | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04224428 Comparator | Jan 2020 → Feb 2022 | diabetic kidney disease | Tanta University | Completed | No outcome recorded |
| Phase 4 | NCT06019728 Background | Nov 2023 → Oct 2024 | Fabry disease | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT03994731 Background | Jun 2019 → Mar 2021 | gout | Amgen | Completed | Met primary |
| Phase 4 | NCT03635957 Background | Sep 2018 → Oct 2019 | gout | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT01852318 Comparator | Apr 2014 → May 2015 | — | National Taiwan University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01940393 Comparator | Aug → Dec 2013 | urticaria | Grupo de Alergología Clínica y Experimental | Completed | No outcome recorded |
| Phase 4 | NCT01586091 Comparator | Feb → Nov 2011 | allergic rhinitis, chronic urticaria | Charite University, Berlin, Germany | Completed | No outcome recorded |
| Phase 4 | NCT00783146 Comparator | Aug → Oct 2004 | seasonal allergic rhinitis | Organon and Co | Completed | Met primary |
| Phase 4 | NCT00783211 Comparator | Aug → Oct 2004 | seasonal allergic rhinitis | Organon and Co | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2011-04-13 | Perrigo Company | Regulatory Perrigo Partner Teva Receives Final OTC Approval for Sales and Distribution of Fexofenadine HCl 60 mg and 180 mg Tablets perrigo.com ↗
Teva Pharmaceutical Industries, Ltd. (Nasdaq: TEVA), has received final OTC approval to sell and distribute fexofenadine HCl 60 mg and 180 mg tablets |
| 2010-11-16 | Impax Laboratories, LLC | Regulatory Impax Laboratories Receives Final FDA Approval for Generic Allegra-D 60mg/120mg Tablets amneal.com ↗
Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Application (ANDA) for the generic version of Allegra-D(R) (Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-release) 60mg/120mg tablets. |
| 2010-10-20 | Wockhardt | Regulatory Wockhardt receives US FDA approval for the generic version of Allegra D® 12 Hour wockhardt.com ↗
Wockhardt is amongst only four companies to have received US FDA approval for this drug which is the most prescribed antihistamine plus decongestant product |
| 2005-07-20 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Tentative Approval of Fexofenadine HCL Tablets tevapharm.com ↗
Jerusalem, Israel, July 20, 2005 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's ANDA for Fexofenadine Hydrochloride Tablets, 30 mg, 60 mg and 180 mg. |
| 2004-02-27 | Impax Laboratories, LLC | Regulatory IMPAX Receives Tentative FDA Approval for Generic Version of Allegra-D amneal.com ↗
the U.S. Food and Drug Administration (FDA) has granted tentative approval to the Company's Abbreviated New Drug Application (ANDA) for its generic version of Allegra(R)-D (Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 60mg/120mg) Extended Release Tablets. |
| 2002-02-12 | Impax Laboratories, LLC | Regulatory IMPAX ANDA Filing for Generic Version of Allegra-D Accepted By FDA amneal.com ↗
IMPAX Laboratories, Inc. (Nasdaq:IPXL) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's filing of an Abbreviated New Drug Application (ANDA) for a generic version of Allegra-D® (Fexofenadine HCl/Pseudoephedrine HCl) Extended Release 60 mg/120mg Tablets. |
All press releases naming this drug 14 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 88 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | fexofenadine | “Ten volunteers received an oral cocktail capsule containing low doses of the probes bupropion (CYP2B6), flurbiprofen (CYP2C9), omeprazole (CYP2C19), dextromethorphan (CYP2D6),...” PMID 24722393 ↗ Apr 201482“Patients received one of the following: Cetirizine 10 mg once per day (QD), Levocetirizine dihydrochloride 5 mg QD, Fexofenadine 60 mg twice per day or 180 mg QD, Loratadine 10...” NCT00866788 ↗ “Drug cocktail comprise of midazolam (2 mg), warfarin (10 mg), vitamin K (10 mg), omeprazole (40 mg), and fexofenadine (30 mg) will be administered on Study Day 1 and 43.” NCT02592317 ↗ “Subjects ingested fexofenadine (540 mg, tablet) at least 50 minutes before and famotidine (40 mg, tablet) 1 hour 50 minutes before the onset of each protocol” NCT06629337 ↗ “For IR prophylaxis, fexofenadine (60 mg or 180 mg orally based on the Principal Investigator's discretion) will be taken the day before each infusion;” NCT03635957 ↗ “The Geneva cocktail is composed of caffeine, bupropion, flurbiprofen, omeprazole, dextromethorphan, midazolam, and fexofenadine.” PMID 32851583 ↗ Nov 2020 “twice-daily fexofenadine 60 mg/phenylephrine 10 mg (FEX60/PE10) combination tablet” NCT02401191 ↗ “Systemic antihistamine oral drug such as fexofenadine, loratadine and cetirizine.” NCT04568902 ↗ “A tablet of fexofenadine Zentiva® 120mg” NCT02590185 ↗ “Fexofenadine single dose 60 mg” NCT01033396 ↗ “Fexofenadine (25mg, R06AX26 )” NCT02438072 ↗ |
| Known as | Allegra | “Examine the relative potency, onset of action and duration of action of fexofenadine HCl 180 mg (Allegra) and montelukast sodium 10 mg (Singulair) as compared to placebo on...” NCT00638118 ↗7“grapefruit juice also has been shown, paradoxically, to decrease circulating concentrations of some drugs, including the non-sedating antihistamine agent, fexofenadine...” NCT01526213 ↗ “Food Study of Fexofenadine Tablets 180 mg and Allegra® Tablets 180 mg” NCT00647985 ↗ “Fexofenadine Hydrochloride 180 mg (Allegra®/Telfast®) Versus Placebo” NCT03664882 ↗ “fexofenadine HCl 180 mg (ALLEGRA)” NCT00637585 ↗ “fexofenadine/Allegra (M016455)” NCT01244217 ↗ “fexofenadine/Allegra (M016455)” NCT01244230 ↗ |
| Known as | fexofenadine HCl | “Examine the relative potency, onset of action and duration of action of fexofenadine HCl 180 mg (Allegra) and montelukast sodium 10 mg (Singulair) as compared to placebo on...” NCT00638118 ↗4“Fexofenadine HCl 30 mg+Pseudophedrine HCl 60 mg” NCT02175485 ↗ “Treatment A- Fexofenadine HCl 60mg” NCT07487909 ↗ “fexofenadine HCl 180 mg (ALLEGRA)” NCT00637585 ↗ |
| Known as | Fexofenadine Hydrochloride | “This study will compare the relative bioavailability (rate and extent of absorption) of 180 mg Fexofenadine Hydrochloride tablets manufactured for TEVA Pharmaceuticals...” NCT00835640 ↗5“Evaluation of Efficacy of Dellegra® Combination Tablet (Fexofenadine Hydrochloride 30mg /Pseudoephedrine Hydrochloride 60mg) in Allergic Rhinitis After Japanese Cedar Antigen...” NCT02175485 ↗ “Fexofenadine Hydrochloride is a third-generation H1 receptor antagonist mainly used to treat allergic diseases such as seasonal allergic rhinitis and chronic idiopathic urticarial.” NCT06548204 ↗ “Fexofenadine Hydrochloride tablets manufactured for TEVA Pharmaceuticals Industries, Ltd.” NCT00835276 ↗ |
| Known as | M016455 | “fexofenadine/Allegra (M016455)” NCT01244230 ↗ |
| Known as | OP2101 | “Fexofenadine Hydrochloride Topical Lotion 1% (OP2101) is a novel formulation developed for the treatment of skin disorders characterized by pruritus.” NCT05461456 ↗ |
| Known as | Telfast | “Fexofenadine Hydrochloride 180 mg (Allegra®/Telfast®) Versus Placebo” NCT03664882 ↗1“H1: Telfast (180mg Fexofenadine)” NCT06152497 ↗ |
| Known as | Zentiva | “A tablet of fexofenadine Zentiva® 120mg” NCT02590185 ↗ |
| Action | Inhibit | “in addition to H1-receptor antagonism” NCT00044824 ↗ |
| Route | Oral | “were taken orally” PMID 19943178 ↗ Nov 2009 |
| Target | TNF | “fexofenadine mediated inhibition of TNF-α signalling” NCT05264025 ↗ |