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Levocabastine HCL
Levocabastine HCL is a H1-receptor antagonist (selective, non-sedating antihistamine) Small molecule drug developed by Chong Kun Dang Pharmaceutical. It is currently in Phase 3 development for Allergic rhinitis, Allergic conjunctivitis. Also known as: investigational product.
Levocabastine is a selective H1-receptor antagonist that blocks histamine-mediated allergic responses.
Levocabastine HCL is a medication used to treat perennial and seasonal allergic rhinitis. It is studied in clinical trials alongside other medications, such as CKD-342 and Mometasone furoate, to evaluate its efficacy and safety.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% 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 | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Levocabastine HCL |
|---|---|
| Also known as | investigational product |
| Sponsor | Chong Kun Dang Pharmaceutical |
| Drug class | H1-receptor antagonist (selective, non-sedating antihistamine) |
| Target | H1 histamine receptor |
| Modality | Small molecule |
| Therapeutic area | Immunology / Allergy |
| Phase | Phase 3 |
Mechanism of action
Levocabastine competitively binds to H1 histamine receptors on mast cells and other immune cells, preventing histamine release and reducing allergic symptoms such as itching, sneezing, and nasal congestion. It is a non-sedating antihistamine formulated for intranasal or ophthalmic delivery to provide rapid local relief of allergic rhinitis and allergic conjunctivitis.
Approved indications
- Allergic rhinitis
- Allergic conjunctivitis
Common side effects
- Nasal irritation
- Headache
- Somnolence
- Taste perversion
Key clinical trials
- Study of Medication for Nonallergic Rhinitis (NAR) Based on Cluster Analysis (NA)
- A Study to Assess Intranasal Repeat Dose Effect of Levocabastine in the Subjects With Allergic Rhinitis (PHASE2)
- A Relative Bioavailability Study of Fluticasone Furoate and Levocabastine (PHASE1)
- A Proof of Concept Study to Assess Effect of Fluticasone Furoate (FF)/Levocabastine Fixed Dose Combination (FDC) Compared With Levocabastine and FF Alone in Subjects With Allergic Rhinitis (AR) (PHASE2)
- Clinical Trial to Evaluate the Efficacy and Safety of CKD-342 (PHASE3)
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:
- Levocabastine HCL CI brief — competitive landscape report
- Levocabastine HCL updates RSS · CI watch RSS
- Chong Kun Dang Pharmaceutical portfolio CI
Frequently asked questions about Levocabastine HCL
What is Levocabastine HCL?
How does Levocabastine HCL work?
What is Levocabastine HCL used for?
Who makes Levocabastine HCL?
Is Levocabastine HCL also known as anything else?
What drug class is Levocabastine HCL in?
What development phase is Levocabastine HCL in?
What are the side effects of Levocabastine HCL?
What does Levocabastine HCL target?
Related
- Drug class: All H1-receptor antagonist (selective, non-sedating antihistamine) drugs
- Target: All drugs targeting H1 histamine receptor
- Manufacturer: Chong Kun Dang Pharmaceutical — full pipeline
- Therapeutic area: All drugs in Immunology / Allergy
- Indication: Drugs for Allergic rhinitis
- Indication: Drugs for Allergic conjunctivitis
- Also known as: investigational product
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing