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submucosal dexamethasone injection
submucosal dexamethasone injection is a Small molecule drug developed by Sun Yat-sen University. It is currently in Phase 1 development.
Submucosal dexamethasone injection is a treatment that involves injecting a small molecule, specifically dexamethasone, into the submucosal tissue. This treatment has been studied for its potential to reduce postoperative sequelae, such as swelling, trismus, and pain, after procedures like impacted mandibular third molar extraction and peritonsillar abscess.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | submucosal dexamethasone injection |
|---|---|
| Sponsor | Sun Yat-sen University |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Prospective Evaluation of Efficacy of Tumescent Steroid Infiltration in Mandibular Third Molar Surgery: a Split Mouth Randomized Study (NA)
- Dexamethasone (4 mg vs. 8 mg) for Pain Control in Dental Implant Surgery (PHASE3)
- Comparison of Submucosal Dexamethasone and Methylprednisolone in Postoperative Sequelae of Parasymphsis Fractures (PHASE2)
- Submucosal Dexamethasone for Control of Post-operative Pain, Trismus, and Swelling After Mandibular Third Molar Surgery (PHASE4)
- The Effect of Dexamethasone Submucosal Injection After Surgical Extraction of Lower Impacted Third Molars on Trismus and Edema (PHASE4)
- Intraosseous Versus Submucosal Dexamethsone Injection in Third Molar Surgery (NA)
- Comparison of Clinical Efficacy of Submucosal Dexamethasone and Oral Trypsin-chymotrypsin for Reduction of Postoperative Sequelae After Lower Third Molar Surgery (NA)
- Tranilast Vs. Steroids to Prevent Esophageal Stricture (TAPES) After Endoscopic Resection for Superficial Neoplasms (PHASE2)
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:
- submucosal dexamethasone injection CI brief — competitive landscape report
- submucosal dexamethasone injection updates RSS · CI watch RSS
- Sun Yat-sen University portfolio CI
Frequently asked questions about submucosal dexamethasone injection
What is submucosal dexamethasone injection?
Who makes submucosal dexamethasone injection?
What development phase is submucosal dexamethasone injection in?
Related
- Manufacturer: Sun Yat-sen University — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing