Last reviewed · How we verify
Bepotastine besilate ophthalmic solution 1.5%
Bepotastine besilate ophthalmic solution 1.5% is a Small molecule drug developed by McCabe Vision Center. It is currently in Phase 1 development. Also known as: Bepreve.
12.1 Mechanism of Action Bepotastine is a topically active, direct H1-receptor antagonist and an inhibitor of the release of histamine from mast cells.
-
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).
| 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 | Bepotastine besilate ophthalmic solution 1.5% |
|---|---|
| Also known as | Bepreve |
| Sponsor | McCabe Vision Center |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | Phase 1 |
Mechanism of action
1 INDICATIONS & USAGE Bepotastine besilate ophthalmic solution 1.5% is a histamine H1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis. Bepotastine besilate ophthalmic solution is a histamine H1 receptor antagonist indicated for the treatment of itching associated with allergic conjunctivitis.
Approved indications
Common side effects
Key clinical trials
- PHASE IV, MULTICENTRIC, DOUBLE-BLIND, RANDOMIZED, CONTROLLED,60 DAYS, PARALLEL GROUPS, SUPERIORITY STUDY, TO COMPARE THE EFFECTIVENESS AND TOXICITY OF BEPOTASTINE 1.5% PF vs. OLOPATADINE 0.2% WITH BAK (Phase 4)
- A Single-Center, Double-Masked, Randomized, Placebo-Controlled, Evaluation of the Onset and Duration of Action of Bepotastine Besilate Ophthalmic Solution in Acute Allergic Conjunctivitis (Phase 2)
- Comparing Patient Satisfaction Throughout the Day With PATADAY (OLOPATADINE HYDROCHLORIDE) 0.2% QD or BEPREVE (BEPOTASTINE BESILATE OPHTHALMIC SOLUTION) 1.5% BID (NA)
- NCT00586664 (Phase 3)
- Use of BEPREVE (Bepotastine Besilate Ophthalmic Solution) 1.5% for Allergic Conjunctivitis and Contact Lenses (Phase 4)
- Phase I Clinical Study for the Evaluation of Safety and Tolerability of PRO-172 Ophthalmic Solution, Manufactured by Laboratorios Sophia, S.A. de C.V., When Applied on the Ocular Surface of Healthy Vo (Phase 1)
- The Evaluation of the Effect of Bepreve, a Topical Ocular Antihistamine, on the Measurement of Wheal and Flare Response From Histamine Skin Prick Testing (Phase 4)
- NCT00586625 (Phase 3)
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:
- Bepotastine besilate ophthalmic solution 1.5% CI brief — competitive landscape report
- Bepotastine besilate ophthalmic solution 1.5% updates RSS · CI watch RSS
- McCabe Vision Center portfolio CI
Frequently asked questions about Bepotastine besilate ophthalmic solution 1.5%
What is Bepotastine besilate ophthalmic solution 1.5%?
How does Bepotastine besilate ophthalmic solution 1.5% work?
Who makes Bepotastine besilate ophthalmic solution 1.5%?
Is Bepotastine besilate ophthalmic solution 1.5% also known as anything else?
What development phase is Bepotastine besilate ophthalmic solution 1.5% in?
Related
- Manufacturer: McCabe Vision Center — full pipeline
- Therapeutic area: All drugs in Ophthalmology
- Also known as: Bepreve
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing