Recce Pharma Clears Indonesian Inspection for Phase 3 Diabetic Foot Trial
Recce Pharmaceuticals' Phase 3 inspection in Indonesia has cleared a critical regulatory hurdle with no findings from Badan POM, advancing RECCE® 327's pathway toward CY26 marketing approval in a US$1.5 billion Asia-Pacific market.
Key Takeaways
- Indonesia's Badan POM completed a routine GCP inspection of Recce's Phase 3 trial with no findings, clearing a critical regulatory hurdle for the R327 diabetic foot infection programme
- Patient dosing continues across five clinical trial sites in Indonesia, with interim data analysis expected once 155 patients have completed the study
- Indonesian regulatory approval is targeted for CY26, with ASEAN market expansion planned to follow the initial approval
- R327 has received FDA Qualified Infectious Disease Product designation, granting Fast Track status and 10 years of US market exclusivity post-approval
- The Asia-Pacific diabetic foot ulcer market represents a US$1.5 billion opportunity, underpinned by Indonesia's position as the country with the fifth highest diabetes prevalence globally
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