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SYL040012
SYL040012 is a Small molecule drug developed by Sylentis, S.A.. It is currently in Phase 2 development. Also known as: No additional names.
SYL040012, also known as bamosiran, is an RNAi inhibitor that targets the beta-2 adrenergic receptor mRNA. It is being studied for its potential to lower intraocular pressure in conditions such as glaucoma, ocular hypertension, and open angle glaucoma.
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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 | SYL040012 |
|---|---|
| Also known as | No additional names |
| Sponsor | Sylentis, S.A. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- SYL040012, Treatment for Open Angle Glaucoma (PHASE2)
- Dose Finding Clinical Trial With SYL040012 to Evaluate the Tolerability and Effect on Intraocular Pressure in Subjects With Ocular Hypertension or Open Angle Glaucoma (PHASE2)
- SYL040012. Tolerance and Effect on Intraocular Pressure in Subjects With Intraocular Pressure (IOP) >= 21 mm Hg (PHASE1, PHASE2)
- Tolerance and Effect on Intraocular Pressure After Administration of SYL040012 (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:
- SYL040012 CI brief — competitive landscape report
- SYL040012 updates RSS · CI watch RSS
- Sylentis, S.A. portfolio CI
Frequently asked questions about SYL040012
What is SYL040012?
Who makes SYL040012?
Is SYL040012 also known as anything else?
What development phase is SYL040012 in?
Related
- Manufacturer: Sylentis, S.A. — full pipeline
- Also known as: No additional names
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing