Product Description
Cetirizine is used to temporarily relieve the symptoms of hay fever (allergy to pollen, dust, or other substances in the air) and allergy to other substances (such as dust mites, animal dander, cockroaches, and molds). These symptoms include sneezing; runny nose; itchy, red, watery eyes; and itchy nose or throat. Cetirizine is also used to treat itching and redness caused by hives. However, cetirizine does not prevent hives or other allergic skin reactions. Cetirizine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. (Sourced from: https://medlineplus.gov/druginfo/meds/a698026.html)
Mechanisms of Action: H1 Antagonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Urticaria | Conjunctivitis | Conjunctivitis, Allergic
Known Adverse Events: Dizziness | Dysgeusia | Headache | Paresthesia | Syncope | Hyperhidrosis | Pharyngitis | Dyspepsia | Hyperemia | Pain Unspecified
Company: GlaxoSmithKline
Company Location: BRENTFORD MIDDLESEX X0 TW8 9GS
Company CEO: Emma Walmsley
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, China, Germany
Active Clinical Trial Count: 4
Highest Development Phases
Phase 3: Conjunctivitis, Allergic|Rhinitis, Allergic
Phase 1: Environmental Hypersensitivity|Healthy Volunteers
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| P001-2019 | P1 |
Not yet recruiting |
Environmental Hypersensitivity |
2025-07-15 |
21% |
| P001-2019 | P1 |
Not yet recruiting |
Environmental Hypersensitivity |
2025-07-15 |
21% |
| T502-SIT-073 | P3 |
Unknown Status |
Rhinitis, Allergic|Conjunctivitis, Allergic |
2025-06-13 |
|
| ACTRN12621001313820 | P1 |
Completed |
Healthy Volunteers |
2022-12-07 |
|
| CTR20201995 | P3 |
Not yet recruiting |
Conjunctivitis, Allergic |
None |