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serratiopeptidase
serratiopeptidase is a Small molecule drug developed by University of Science and Technology, Yemen. It is currently in Phase 3 development. Also known as: Amoxicillin, Metronidazole, and Diclofenac sodium.
Serratiopeptidase is a proteolytic enzyme produced by the enterobacterium Serratia marcescens ATCC 21074, which is originally isolated from the silkworm intestine. It has been studied for its efficacy in treating conditions such as inflammation, swelling, and trismus, particularly after third molar surgery, with a typical dosage of 5 mg.
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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 | serratiopeptidase |
|---|---|
| Also known as | Amoxicillin, Metronidazole, and Diclofenac sodium |
| Sponsor | University of Science and Technology, Yemen |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- A Comparison of Recovery After Impacted Wisdom Tooth Removal (PHASE3)
- The Effect of Supplementary Foods Containing Trypsin, Chymotrypsin and Serratia Peptidase on Healing After Impacted Wisdom Tooth Surgery (NA)
- Evaluating the Combined Effect of Oral Premedications on Inferior Alveolar Nerve Block Effectiveness (PHASE3)
- Lung Dispersing, Turbid Descending and Gut Clearing Decoction for Bronchiectasis (NA)
- Efficacy and Safety of Hydrogen Inhalation on Bronchiectasis: A Randomized, Multi-center, Double-blind Study (NA)
- Efficacy Evaluation of the (Serodase 5 mg Tablet) in the Treatment of Inflammation After Third Molar Surgery (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:
- serratiopeptidase CI brief — competitive landscape report
- serratiopeptidase updates RSS · CI watch RSS
- University of Science and Technology, Yemen portfolio CI
Frequently asked questions about serratiopeptidase
What is serratiopeptidase?
Who makes serratiopeptidase?
Is serratiopeptidase also known as anything else?
What development phase is serratiopeptidase in?
Related
- Manufacturer: University of Science and Technology, Yemen — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Amoxicillin, Metronidazole, and Diclofenac sodium
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing