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BRM421 Ophthalmic Solution, 0.06%
BRM421 Ophthalmic Solution, 0.06% is a Small molecule drug developed by BRIM Biotechnology Inc.. It is currently in Phase 2 development.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | BRM421 Ophthalmic Solution, 0.06% |
|---|---|
| Sponsor | BRIM Biotechnology Inc. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- BRM421 Ophthalmic Solution in Patients With Limbal Stem Cell Deficiency
- A Dose Regimen Study of BRM421 Ophthalmic Solution in Patients With Dry Eye Disease (PHASE2)
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:
- BRM421 Ophthalmic Solution, 0.06% CI brief — competitive landscape report
- BRM421 Ophthalmic Solution, 0.06% updates RSS · CI watch RSS
- BRIM Biotechnology Inc. portfolio CI
Frequently asked questions about BRM421 Ophthalmic Solution, 0.06%
What is BRM421 Ophthalmic Solution, 0.06%?
Who makes BRM421 Ophthalmic Solution, 0.06%?
What development phase is BRM421 Ophthalmic Solution, 0.06% in?
Related
- Manufacturer: BRIM Biotechnology Inc. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing