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Hydrogel treatment
Hydrogel treatment is a Small molecule drug developed by Carlos E Salas. It is currently in Phase 2 development. Also known as: Gel Comfeel ®, Coloplast, Hydrogel Purilon ®.
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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 | Hydrogel treatment |
|---|---|
| Also known as | Gel Comfeel ®, Coloplast, Hydrogel Purilon ® |
| Sponsor | Carlos E Salas |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Arthrosemid vs. Steroid for the Management Knee Osteoarthritis (PHASE4)
- SpaceOAR Post-Market Registry Study
- A Study to Evaluate the Efficacy and Safety of OTX-TKI (Axitinib Implant) in Participants With Non-Proliferative Diabetic Retinopathy (PHASE3)
- Mobilization and Outcomes After Venous Closure
- SpaceIT Hydrogel System for Perirectal Spacing (NA)
- Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer (NA)
- Daily Activity and Clinical Outcome Measurement of Arthrosamid® Administration in Symptomatic Knee Osteoarthritis. (NA)
- Evaluation of Tumor Control Based on Serial Multiparametric MRI and Post-Treatment Biopsies For Patients Treated With Dose Intensification to the Dominant Intra-Prostatic Lesion (DIL) Using Ultra-Hypofractionated, MR-Guided Radiotherapy (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:
- Hydrogel treatment CI brief — competitive landscape report
- Hydrogel treatment updates RSS · CI watch RSS
- Carlos E Salas portfolio CI
Frequently asked questions about Hydrogel treatment
What is Hydrogel treatment?
Who makes Hydrogel treatment?
Is Hydrogel treatment also known as anything else?
What development phase is Hydrogel treatment in?
Related
- Manufacturer: Carlos E Salas — full pipeline
- Also known as: Gel Comfeel ®, Coloplast, Hydrogel Purilon ®
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing