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Hydroxyzine Hydrochloride (HYDROXYZINE)
Hydroxyzine Hydrochloride (HYDROXYZINE) is a small molecule antihistamine that targets the histamine H1 receptor. Originally developed by Pfizer in 1956, it is currently owned by the same company and is off-patent, with 13 generic manufacturers. This medication is used to treat various allergic conditions, including allergic conjunctivitis, rhinitis, and urticaria. Hydroxyzine works by blocking the action of histamine, a chemical released during allergic reactions, thereby reducing symptoms such as itching and nasal discharge. As an off-patent medication, it is widely available in generic forms.
At a glance
| Generic name | HYDROXYZINE |
|---|---|
| Sponsor | Pfizer |
| Drug class | Antihistamine |
| Target | Histamine H1 receptor |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 1956 |
Approved indications
- Allergic conjunctivitis
- Allergic rhinitis
- Atopic dermatitis
- Dermatographic urticaria
- Itching of skin
- Nasal discharge
- Urticaria
Common side effects
- Drowsiness
- Dry mouth
- Pruritus
- Rash
- Urticaria
- Headache
- Allergic reaction
- QT prolongation
- Torsade de Pointes
- Hallucination
Key clinical trials
- Alternate Pre-med in Anti-Cluster of Differentiation 20 (CD20) Pilot Project (PHASE3)
- E7 TCR T Cells for Human Papillomavirus-Associated Cancers (PHASE1,PHASE2)
- CLOZAPINE Response in Biotype-1 (PHASE4)
- A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Negative, Chronic Hepatitis B Virus (HBV) Infection (PHASE2)
- Extension Study of the Safety and Efficacy of Multi-dose Intravenous ARC-520 in Patients With Chronic Hepatitis B (HBV) Infection (PHASE2)
- Study of ARC-520 With or Without Other Drugs Used in the Treatment of Chronic Chronic Hepatitis B Virus (HBV) (PHASE2)
- A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Positive, Chronic Hepatitis B Virus Infection (PHASE2)
- A Study of ARC-520 at Varying Infusion Rates in Healthy Adult Volunteers (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Hydroxyzine Hydrochloride CI brief — competitive landscape report
- Hydroxyzine Hydrochloride updates RSS · CI watch RSS
- Pfizer portfolio CI