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Hydroxizine
Hydroxizine is a Small molecule drug developed by King Faisal Specialist Hospital & Research Center. It is currently in Phase 1 development for Allergic conjunctivitis, Allergic rhinitis, Atopic dermatitis.
-
Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Hydroxizine |
|---|---|
| Sponsor | King Faisal Specialist Hospital & Research Center |
| Target | 5-hydroxytryptamine receptor 2A, Cytochrome P450 2D6, D(2) dopamine receptor |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 1 |
Approved indications
- Allergic conjunctivitis
- Allergic rhinitis
- Atopic dermatitis
- Dermatographic urticaria
- Itching of skin
- Nasal discharge
- Urticaria
Common side effects
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 |
|---|---|
| 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:
- Hydroxizine CI brief — competitive landscape report
- Hydroxizine updates RSS · CI watch RSS
- King Faisal Specialist Hospital & Research Center portfolio CI
Frequently asked questions about Hydroxizine
What is Hydroxizine?
What is Hydroxizine used for?
Who makes Hydroxizine?
What development phase is Hydroxizine in?
What does Hydroxizine target?
Related
- Target: All drugs targeting 5-hydroxytryptamine receptor 2A, Cytochrome P450 2D6, D(2) dopamine receptor
- Manufacturer: King Faisal Specialist Hospital & Research Center — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Allergic conjunctivitis
- Indication: Drugs for Allergic rhinitis
- Indication: Drugs for Atopic dermatitis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing