Drugs / Loratadine
Loratadine
also known as
Claritin · BAY76-2211 · Children's Claritin Syrup · Claritin Syrup · Clarityne · Xisimin
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed seasonal allergic rhinitis 1 milestone | |||||
| Filed | US (FDA) | Claritin | seasonal allergic rhinitis | 2002-03-08 | “it has filed with the U.S. Food and Drug Administration (FDA) to switch all of Claritin's formulations from prescription to OTC marketing status.” amneal.com ↗ “it has filed with the U.S. Food and Drug Administration (FDA) to switch all CLARITIN formulations from prescription to OTC marketing status.” amneal.com ↗ |
| Approved Indication not stated 4 milestones | |||||
| Label expansion | US (FDA) | LORATADINE | — | 2022-12-08 | fda.gov ↗ |
| Label expansions (3) | US (FDA) | CLARITIN HIVES RELIEF | — | 2000-12-04 – 2003-11-19 | fda.gov ↗ |
| Label expansion | US (FDA) | CLARITIN | — | 1995-09-20 | fda.gov ↗ |
| Approved | US (FDA) | CLARITIN | — | 1993-04-12 | fda.gov ↗ |
Trials 36
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT04211259 | Apr 2022 → Aug 2026 overdue | plasma cell myeloma | Rutgers, The State University of New Jersey | Recruiting | No outcome recorded |
| Phase 0 | NCT02392039 | Dec 2015 → Apr 2018 | lymphoma | M.D. Anderson Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 13 trials | ||||||
| Phase 1 | NCT03151720 | Jun → Jul 2017 | — | Xian-Janssen Pharmaceutical Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT00721331 | Jul → Sep 2008 | atopic eczema | Zalicus | Completed | No outcome recorded |
| Phase 1 | NCT00946608 | Jun → Aug 2005 | allergic disease | Sandoz | Completed | No outcome recorded |
| Phase 29 trials · 1 missed | ||||||
| Phase 2 | NCT07661459 | Jun 2026 → Jul 2027 expected | cancer | Val Adams | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05421416 | Nov 2024 → Dec 2026 expected | disease related to hematopoietic stem cell transplant | AHS Cancer Control Alberta | Recruiting | No outcome recorded |
| Phase 2 | NCT05190627 | Nov 2021 → Dec 2022 | lymphangioleiomyomatosis | Bellvitge Biomedical Research Institute | Unknown | No outcome recorded |
| Phase 2 | NCT04248712 | Jul 2020 → Dec 2021 | eosinophilic esophagitis | Mayo Clinic | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03883386 | Jun → Oct 2019 | bone pain, periodic | University of Michigan | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04179461 | Mar 2018 → Oct 2019 | childhood onset asthma | Children's Hospital Medical Center, Cincinnati | Completed | No outcome recorded |
| Phase 2 | NCT03640273 | Nov 2017 → Jan 2018 | allergic rhinitis | Thammasat University | Completed | No outcome recorded |
| Phase 2 | NCT01712009 | Nov 2012 → Mar 2015 | bone pain, periodic | Amgen | Completed | Missed primary |
| Phase 2 | NCT00796211 | Nov → Dec 2008 | psoriasis | Zalicus | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05043350 | Sep 2021 → Jul 2022 | COVID-19 | Ain Shams University | Completed | No outcome recorded |
| Phase 310 trials · 2 met primary · 2 missed | ||||||
| Phase 3 | NCT06531707 | May 2024 → Jan 2025 overdue | common cold | Laboratorios Silanes S.A. de C.V. | Recruiting | No outcome recorded |
| Phase 3 | NCT05243706 | Mar 2022 → Sep 2023 | poisoning | Ain Shams University | Unknown | No outcome recorded |
| Phase 3 | NCT03372473 | Jan → Feb 2016 | childhood onset asthma | Innovacion y Desarrollo de Estrategias en Salud | Completed | No outcome recorded |
| Phase 3 | NCT01673620 | Jul → Oct 2012 | allergic rhinitis | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT01055756 | Jan → Apr 2010 | allergic rhinitis | Azidus Brasil | Withdrawn | No outcome recorded |
| Phase 3 | NCT00423995 | Nov 2006 → Mar 2007 | seasonal allergic rhinitis | Organon and Co | Completed | Met primary |
| Phase 3 | NCT00319995 | Mar → Jun 2006 | seasonal allergic rhinitis | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00979901 | Mar → May 2000 | seasonal allergic rhinitis | Organon and Co | Completed | Met primary |
| Phase 3 | NCT00963599 | Sep → Nov 1999 | seasonal allergic rhinitis | Organon and Co | Completed | Missed primary |
| Phase 3 | NCT03855228 | Mar → Aug 1995 | allergic rhinitis | Organon and Co | Completed | Missed primary |
| Phase 48 trials | ||||||
| Phase 4 | NCT06217367 | Dec 2023 → Jun 2024 | allergic rhinitis, dysautonomia-like disorder | Lakehead University | Unknown | No outcome recorded |
| Phase 4 | NCT04162795 | Nov 2019 | allergic rhinitis | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT03443843 | Feb → May 2018 | allergic rhinitis | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT02513290 | Aug 2013 → Aug 2014 | allergic rhinitis | University of Southern Santa Catarina | Completed | No outcome recorded |
| Phase 4 | NCT01451996 | Oct 2011 → Jul 2012 | — | University of Chicago | Completed | No outcome recorded |
| Phase 4 | NCT01469234 | Oct → Nov 2011 | rhinitis | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT00730912 | Jun → Dec 2008 | perennial allergic rhinitis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 4 | NCT00963573 | Sep 2003 → Nov 2006 | rhinitis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT07300735 | Mar 2025 → Mar 2027 expected | hematopoietic and lymphoid cell neoplasm, neutropenia | Alexandria University | Recruiting | No outcome recorded |
| — | NCT02653339 | Jun 2016 → Mar 2018 | perennial allergic rhinitis | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| — | NCT00837915 | Jun → Aug 2002 | — | Ranbaxy Laboratories Limited | Completed | No outcome recorded |
| Comparator or background therapy37 trials | ||||||
| Phase 1 | NCT06955741 Background | May → Sep 2025 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT04568902 Background | Sep 2020 → Oct 2025 | breast cancer | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02583594 Background | Dec 2015 → Mar 2016 | multiple sclerosis | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 1 | NCT01390441 Background | Jul 2011 → Apr 2014 | rheumatoid arthritis | Merck Sharp & Dohme LLC | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT06265077 Comparator | Feb → Oct 2024 | breast cancer | Noha Mansour | Completed | No outcome recorded |
| Phase 2 | NCT03376594 Comparator | Jul 2017 → Feb 2018 | allergic rhinitis | Thammasat University | Completed | No outcome recorded |
| Phase 2 | NCT02495077 Background | Nov 2015 → Jul 2021 | — | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Missed primary |
| Phase 2 | NCT02576808 Comparator | Oct 2015 → Oct 2017 | allergic rhinitis | Thai Traditional Medical Knowledge Fund | Completed | No outcome recorded |
| Phase 2 | NCT02339714 Comparator | Mar 2015 → May 2016 | perennial allergic rhinitis | Zhao Hong | Completed | No outcome recorded |
| Phase 2 | NCT01311336 Comparator | May 2011 → Jun 2013 | — | University of Vermont | Unknown | No outcome recorded |
| Phase 2 | NCT01330017 Background | Mar → May 2011 | seasonal allergic rhinitis | Bayer | Completed | Missed primary |
| Phase 2 | NCT00866788 Background | Mar 2009 → Jan 2010 | chronic idiopathic urticaria | Genentech, Inc. | Completed | Met primary |
| Phase 2 | NCT00481676 Background | May 2007 → Apr 2009 | chronic urticaria | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT05263206 Background | Feb 2022 → Jun 2027 expected | — | Sanofi | Recruiting | No outcome recorded |
| Phase 3 | NCT02478398 Background | Jul 2015 → Nov 2018 | seasonal allergic rhinitis | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT02007434 Background | Dec 2013 → Jun 2014 | — | Kythera Biopharmaceuticals | Completed | Missed primary |
| Phase 3 | NCT01700192 Background | Jan 2013 → Apr 2015 | perennial allergic rhinitis | ALK-Abelló A/S | Completed | Met primary |
| Phase 3 | NCT01228630 Background | Aug 2011 → Apr 2012 | perennial allergic rhinitis | Azidus Brasil | Completed | No outcome recorded |
| Phase 3 | NCT01413958 Background | Aug → Oct 2011 | seasonal allergic rhinitis | Bayer | Completed | Missed primary |
| Phase 3 | NCT00550550 Background | Nov 2007 → Sep 2009 | allergic rhinitis, conjunctivitis | ALK-Abelló A/S | Completed | Met primary |
| Phase 3 | NCT00562159 Background | Nov 2007 → Sep 2009 | allergic disease, conjunctivitis, rhinitis | ALK-Abelló A/S | Completed | Met primary |
| Phase 3 | NCT00963469 Comparator | Aug → Nov 2001 | seasonal allergic rhinitis | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00972738 Comparator | Apr → Jul 2001 | seasonal allergic rhinitis | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00960141 Comparator | Aug → Oct 2000 | seasonal allergic rhinitis | Organon and Co | Completed | Met primary |
| Phase 4 | NCT07532993 Comparator | Sep 2026 → Feb 2027 expected | allergic rhinitis | Liaquat National Hospital & Medical College | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07101445 Background | Sep 2025 → Dec 2026 expected | plasma cell myeloma | Emory University | Recruiting | No outcome recorded |
| Phase 4 | NCT06250400 Background | Mar 2024 → Jul 2025 | chronic idiopathic urticaria | Hangzhou Grand Biologic Pharmaceutical, Inc. | Unknown | No outcome recorded |
| Phase 4 | NCT06019728 Background | Nov 2023 → Oct 2024 | Fabry disease | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT05750875 Comparator | May → Oct 2022 | chronic kidney disease, uremia | King Edward Medical University | Completed | No outcome recorded |
| Phase 4 | NCT05265910 Comparator | Dec 2021 → Apr 2022 | conjunctivitis | Andover Research Eye Institute | Completed | No outcome recorded |
| Phase 4 | NCT03004131 Comparator | Jan → Mar 2017 | seasonal allergic rhinitis | MEDA Pharma GmbH & Co. KG | Completed | No outcome recorded |
| Phase 4 | NCT01154153 Background | Jun → Oct 2010 | allergic rhinitis | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT00561717 Comparator | Oct → Dec 2007 | seasonal allergic rhinitis | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT00449072 Comparator | Mar 2007 → Oct 2011 | perennial allergic rhinitis | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT02932774 Comparator | Mar → Jul 2001 | seasonal allergic rhinitis | Johnson & Johnson Consumer and Personal Products Worldwide | Completed | No outcome recorded |
| — | NCT07575464 Background | May → Jul 2026 overdue | urticaria | University of Medicine and Pharmacy at Ho Chi Minh City | Not yet recruiting | No outcome recorded |
| — | NCT01507792 Background | Jan 2002 → Jan 2011 | bronchial disorder, disorder of iron metabolism and transport, laryngeal disorder | University of Turin, Italy | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2004-03-05 | Impax Laboratories, LLC | Regulatory IMPAX Receives Final FDA Approval for Generic Version of Claritin-D 24-Hour; Third ANDA Approval of 2004 for IMPAX amneal.com ↗
IMPAX Laboratories, Inc. (Nasdaq:IPXL) today announced that the U.S. Food and Drug Administration (FDA) has granted final approval to the Company's Abbreviated New Drug Application (ANDA) for a generic version of Claritin(R)-D 24-Hour (Loratadine and Pseudoephedrine Sulfate, 10mg/240mg) Extended Release Tablets. |
| 2003-11-30 | Impax Laboratories, LLC | Regulatory MPAX Receives FDA Approval for Generic Claritin Reditabs amneal.com ↗
IMPAX Laboratories, Inc. (NASDAQ:IPXL) today announced that the U.S. Food and Drug Administration (FDA) has granted approval to the Company's Abbreviated New Drug Application (ANDA) for a generic version of Claritin(R) Reditabs(R) (Loratadine Orally Disintegrating Tablets) 10 mg. |
| 2003-11-14 | Perrigo Company | Regulatory Perrigo Company Announces Approvals to Market Three New Products perrigo.com ↗
The Perrigo Company (NASDAQ: PRGO) today announced that it will begin marketing three new products following U.S. Food and Drug Administration (FDA) approvals. |
| 2003-01-31 | Impax Laboratories, LLC | Regulatory IMPAX Receives Final FDA Approval for a Generic Version of Claritin-D 12-Hour amneal.com ↗
IMPAX Laboratories, Inc. (NASDAQ:IPXL) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Abbreviated New Drug Application (ANDA) for a generic version of Claritin®-D 12-Hour (Loratadine/Pseudoephedrine sulfate, 5mg/120mg) Extended Release Tablets. |
| 2002-05-30 | Impax Laboratories, LLC | Regulatory IMPAX Receives FDA Tentative Approval for a Generic Version of Claritin-D 12-Hour amneal.com ↗ |
| 2002-05-29 | Impax Laboratories, LLC | Regulatory IMPAX Receives FDA Tentative Approval for a Generic Version of Claritin-D 24-Hour amneal.com ↗
IMPAX Laboratories, Inc. (Nasdaq:IPXL) today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval to the Company's Abbreviated New Drug Application (ANDA) for a generic version of Claritin-D® 24-Hour (loratadine/pseudoephedrine sulfate, 10mg/240mg) Extended Release Tablets. |
| 2000-08-23 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Received Two Approvals:Final Approval for Enalapril to be Shipped Immediately Tentative Approval for Loratadine tevapharm.com ↗
Teva has also received tentative approval for Loratadine 10mg Tablets. |
All press releases naming this drug 14 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 74 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | loratadine | “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 ↗71“Children's Claritin® Syrup [5 mg of loratadine per 5 mL] could be taken orally for the relief of AR symptoms throughout the study on an as needed basis” NCT01154153 ↗ “Loratadine 10 mg RediTabs tablets were dosed orally once daily as rescue medication” NCT00562159 ↗ “Systemic antihistamine oral drug such as fexofenadine, loratadine and cetirizine.” NCT04568902 ↗ “CRx-197 high dose topical cream (0.1% nortriptyline HCl +0.3% loratadine)” NCT00796211 ↗ “AntiH1-histaminic drug = Loratadine 10 mg” NCT01507792 ↗ “Loratadine + pseudoephedrine” NCT01228630 ↗ “5 mg of loratadine per 5 mL” NCT00449072 ↗ “Drug: Loratadine” NCT00963573 ↗ “Loratadine” NCT01390441 ↗ “loratadine” NCT04179461 ↗ |
| Known as | BAY76-2211 | “Loratadine (Claritin, BAY76-2211)” NCT04162795 ↗ |
| Known as | Children's Claritin Syrup | “Participants were provided Children's Claritin® Syrup (5 mg of loratadine per 5 mL), as rescue medication for the relief of allergic rhinitis (AR) symptoms, and could be used...” NCT00449072 ↗ |
| Known as | Claritin | “Participants were provided Children's Claritin® Syrup (5 mg of loratadine per 5 mL), as rescue medication for the relief of allergic rhinitis (AR) symptoms, and could be used...” NCT00449072 ↗5“Loratadine is marketed by Schering-Plough\[needs update\] under several trade names (e.g., Claritin) and also by Shionogi in Japan.” NCT02653339 ↗ “fluticasone propionate nasal spray (Flonase) plus loratadine 10 mg tablets (Claritin)” NCT03004131 ↗ “Claritin (Loratadine) 10 mg Tablets Under Fed Conditions (Schering)” NCT00946608 ↗ “Loratadine (Claritin, BAY76-2211)” NCT04162795 ↗ |
| Known as | Claritin Syrup | “Children's Claritin® Syrup [5 mg of loratadine per 5 mL] could be taken orally for the relief of AR symptoms throughout the study on an as needed basis” NCT01154153 ↗ |
| Known as | Clarityne | “Participants will receive 10 mg loratadine as Clarityne (reference treatment) as per the treatment sequence.” NCT03151720 ↗ |
| Known as | Xisimin | “Participants will receive 10 mg loratadine as Xisimin (test treatment) as per the treatment sequence.” NCT03151720 ↗ |
| Action | Inhibit | “10 mg of loratadine, an antihistamine” PMID 19549427 ↗ May 2009 |
| Modality | Small molecule | “the tricyclic antihistamine loratadine” NCT05190627 ↗ |
| Route | Oral | “dosed orally once daily” NCT00550550 ↗ |