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Monovisc
Monovisc is a Small molecule drug developed by October 6 University. 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 | Monovisc |
|---|---|
| Sponsor | October 6 University |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- USC-Exos in Corpus Spongiosum Reconstruction for Hypospadias (NA)
- Clinical Investigation on Lips Treated With HA-filler (NA)
- Using Different Biomaterials to Preserve Bone After Tooth Extraction (NA)
- Hyaluronic Acid and Albumin-PRF in Non-Surgical Periodontal Therapy (NA)
- Early vs Delayed Intravesical Blad-Care During BCG Therapy (NA)
- A Clinical Investigation of the Decoria® Aesthetic Group (DAG) for Correction of Nasolabial Folds (NLF) (NA)
- Is Cross-linked Hyaluronic Acid a Biologic Alternative for Alveolar Ridge Preservation? (NA)
- A Post-market-clinical Follow-up Investigation of Safety and Performance by Decoria® Voluma (NA)
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:
- Monovisc CI brief — competitive landscape report
- Monovisc updates RSS · CI watch RSS
- October 6 University portfolio CI
Frequently asked questions about Monovisc
What is Monovisc?
Who makes Monovisc?
What development phase is Monovisc in?
Related
- Manufacturer: October 6 University — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing