Overview
Fexofenadine is an over-the-counter second-generation antihistamine used in the treatment of various allergic symptoms. It is selective for the H receptor, carries little-to-no activity at off-targets, and does not cross the blood-brain barrier - this is in contrast to previous first-generation antihistamines, such as diphenhydramine, which readily bind to off-targets that contribute to side effects such as sedation. Fexofenadine is the major active metabolite of terfenadine and is administered as a racemic mixture in which both enantiomers display approximately equivalent antihistamine activity.
Background
Fexofenadine is an over-the-counter second-generation antihistamine used in the treatment of various allergic symptoms. It is selective for the H receptor, carries little-to-no activity at off-targets, and does not cross the blood-brain barrier - this is in contrast to previous first-generation antihistamines, such as diphenhydramine, which readily bind to off-targets that contribute to side effects such as sedation. Fexofenadine is the major active metabolite of terfenadine and is administered as a racemic mixture in which both enantiomers display approximately equivalent antihistamine activity.
Indication
In the United States, fexofenadine is indicated for the symptomatic treatment of allergic rhinitis in patients ≥2 years old and chronic idiopathic urticaria in patients ≥6 months old. In Canada, fexofenadine carries the same indications but is approved only for patients ≥12 years old. Fexofenadine is also available in combination with pseudoephedrine for the symptomatic treatment of season allergic rhinitis in patients ≥12 years old.
Associated Conditions
- Allergic Rhinitis (AR)
- Chronic Idiopathic Urticaria
- Seasonal Allergic Rhinitis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/01/21 | Phase 2 | Recruiting | |||
2024/08/12 | Phase 2 | Not yet recruiting | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||
2024/06/20 | Phase 4 | Completed | |||
2024/02/29 | Phase 1 | Completed | Opella Healthcare Group SAS, a Sanofi Company | ||
2024/01/16 | Phase 1 | Completed | |||
2023/08/31 | Phase 4 | Completed | |||
2023/07/06 | Phase 1 | Completed | |||
2023/02/09 | Phase 4 | Not yet recruiting | |||
2023/01/20 | Phase 3 | Completed | Opella Healthcare Group SAS, a Sanofi Company | ||
2022/07/18 | Phase 1 | Completed | OrchestratePharma GmbH |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| STAT RX USA LLC | 16590-852 | ORAL | 180 mg in 1 1 | 12/15/2009 | |
| Strategic Sourcing Services LLC | 70677-1278 | ORAL | 60 mg in 1 1 | 5/9/2025 | |
| Physicians Total Care, Inc. | 54868-5419 | ORAL | 180 mg in 1 1 | 9/25/2012 | |
| Aphena Pharma Solutions - Tennessee, Inc. | 43353-244 | ORAL | 180 mg in 1 1 | 7/30/2008 | |
| Dr. Reddy's Laboratories Limited | 55111-783 | ORAL | 60 mg in 1 1 | 5/6/2025 | |
| NUVICARE LLC | 84324-008 | ORAL | 180 mg in 1 1 | 6/9/2025 | |
| Lake Erie Medical DBA Quality Care Products LLC | 49999-772 | ORAL | 180 mg in 1 1 | 6/7/2010 | |
| CVS Pharmacy | 69842-914 | ORAL | 180 mg in 1 1 | 4/16/2025 | |
| Physicians Total Care, Inc. | 54868-5409 | ORAL | 180 mg in 1 1 | 2/18/2010 | |
| Bryant Ranch Prepack | 71335-2165 | ORAL | 60 mg in 1 1 | 9/9/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| TELFAST TABLET 120 mg | SIN11704P | TABLET, FILM COATED | 120 mg | 11/1/2001 | |
| TELFAST TABLET 180 mg | SIN11699P | TABLET, FILM COATED | 180 mg | 10/27/2001 | |
| FEXODIN FILM COATED TABLET 120MG | SIN15714P | TABLET, FILM COATED | 120mg | 6/12/2019 | |
| Telfast Oral Suspension 6 mg/ml | SIN14199P | SUSPENSION | 30.00 mg/5 ml | 7/20/2012 | |
| EXODIN TABLET 180MG | SIN14591P | TABLET, FILM COATED | 180mg | 8/18/2014 | |
| FEXOFEN FILM-COATED TABLET 180MG | SIN16296P | TABLET, FILM COATED | 180.00mg | 8/10/2021 | |
| TELFAST D TABLET | SIN12071P | TABLET, FILM COATED | 60 mg | 9/13/2002 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Fexofenadine Hydrochloride Tablets | 国药准字HJ20210012 | 化学药品 | 片剂 | 2/10/2021 | |
| Fexofenadine Hydrochloride Tablets | 国药准字H20060149 | 化学药品 | 片剂 | 5/8/2020 | |
| Fexofenadine Hydrochloride Tablets | 国药准字H20060330 | 化学药品 | 片剂 | 8/30/2020 | |
| Fexofenadine Hydrochloride Tablets | 国药准字HJ20210011 | 化学药品 | 片剂 | 2/10/2021 | |
| Fexofenadine Hydrochloride Tablets | 国药准字H20153221 | 化学药品 | 片剂 | 8/12/2020 | |
| Fexofenadine Hydrochloride Tablets | 国药准字H20080437 | 化学药品 | 片剂 | 3/24/2023 | |
| Fexofenadine Hydrochloride Tablets | 国药准字H20080123 | 化学药品 | 片剂 | 2/21/2023 | |
| Fexofenadine Hydrochloride Tablets | 国药准字H20130040 | 化学药品 | 片剂 | 1/6/2023 | |
| Fexofenadine Hydrochloride Tablets | 国药准字H20080710 | 化学药品 | 片剂 | 4/23/2023 | |
| Fexofenadine Hydrochloride Tablets | 国药准字H20090333 | 化学药品 | 片剂 | 5/5/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| TELFAST TAB 180MG | N/A | N/A | N/A | 4/26/1999 | |
| FEXODINE TAB 180MG | N/A | N/A | N/A | 10/14/2007 | |
| NAXODINE TABLETS 180MG | N/A | N/A | N/A | 12/11/2024 | |
| UFEXO 180 TABLETS 180MG | N/A | N/A | N/A | 3/20/2020 | |
| TELFAST ORAL SUSPENSION PEDIATRIC 30MG/5ML | N/A | N/A | N/A | 7/14/2011 | |
| TELFAST D TAB | N/A | N/A | N/A | 10/27/2000 | |
| EFORMAT FEXOFENADINE HYDROCHLORIDE TABLETS 180MG | N/A | N/A | N/A | 12/11/2024 | |
| ALEACT 120 TABLETS 120MG | N/A | N/A | N/A | 7/19/2021 | |
| ALERTEX TABLETS 180MG | N/A | N/A | N/A | 8/23/2024 | |
| TELFAST TAB 120MG | N/A | N/A | N/A | 4/26/1999 |