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OLT1177 Gel
OLT1177 Gel is a Small molecule drug developed by Olatec Therapeutics LLC. It is currently in Phase 2 development. Also known as: OLT1177.
OLT1177 Gel is a treatment being studied for moderate to severe pain associated with osteoarthritis of the knee. It is being tested in a randomized, double-blind, vehicle-controlled clinical trial.
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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 | OLT1177 Gel |
|---|---|
| Also known as | OLT1177 |
| Sponsor | Olatec Therapeutics LLC |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Study of OLT1177 Gel to Treat Moderate to Severe OA Knee Pain (PHASE2)
- Phase 2 Efficacy Trial of OLT1177 Gel in Subjects With Moderate to Severe Pain Associated With OA of the Knee (PHASE2)
- Phase 1 Safety Study of Single and Multi-Dose Topically Applied OLT1177 Gel in Healthy Subjects (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:
- OLT1177 Gel CI brief — competitive landscape report
- OLT1177 Gel updates RSS · CI watch RSS
- Olatec Therapeutics LLC portfolio CI
Frequently asked questions about OLT1177 Gel
What is OLT1177 Gel?
Who makes OLT1177 Gel?
Is OLT1177 Gel also known as anything else?
What development phase is OLT1177 Gel in?
Related
- Manufacturer: Olatec Therapeutics LLC — full pipeline
- Also known as: OLT1177
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing