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Solaraze
Solaraze is a Small molecule drug developed by Infectopharm Arzneimittel GmbH. It is currently in Phase 3 development.
Solaraze, also known as diclofenac, is a small molecule cyclooxygenase inhibitor used to treat various conditions, including inflammation and pain. It is available in different forms, including oral, topical, and rectal administration, and can provide pain relief lasting up to eight hours.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Solaraze |
|---|---|
| Sponsor | Infectopharm Arzneimittel GmbH |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Diclofenac as a KMO Inhibitor (EARLY_PHASE1)
- Efficacy of Chemically Distinct Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) and Pain Phenotypes in Adhesive Capsulitis (NA)
- Comparative Clinical Study to Evaluate the Possible Efficacy and Safety of Oral N-Acetyl Cysteine Versus Rectal Diclofenac in the Prevention of Post Endoscopic Retrograde Cholangiopancreatography Pancreatitis (PHASE1, PHASE2)
- Pain Control After Open Radical Nephrectomy: Thoracic Paravertebral Block Versus External Oblique Intercostal Block (NA)
- Counterpain PXM Versus Diclofenac Versus Piroxicam (PHASE3)
- KF2022#4-trial: Effects of a Beta Blocker and NSAID on CYP Mediated Drug Metabolism (NA)
- Comparison of the Effectiveness of Therapeutic Ultrasound and Phonophoresis in Chronic Low Back Pain (NA)
- Helping Osteoarthritis Patients to Walk With NSAID (PHASE4)
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:
- Solaraze CI brief — competitive landscape report
- Solaraze updates RSS · CI watch RSS
- Infectopharm Arzneimittel GmbH portfolio CI
Frequently asked questions about Solaraze
What is Solaraze?
Who makes Solaraze?
What development phase is Solaraze in?
Related
- Manufacturer: Infectopharm Arzneimittel GmbH — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing