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UB151

Epalrestat Tablets

提交项目新药候选物数据库

UB151

ProductEpalrestat Tablets
Strength50mg
IndicationsDiabetic peripheral neuropathy; Otitis media; Bronchitis; Pneumonia; Respiratory tract infection; Urinary tract infection; Skin and soft tissue infection; Bone infection; Joint infection; Septicaemia; Endocarditis infective; Hepatobiliary infection; Eye infection; Ear infection; Nasal infection; Throat infection; Surgical prophylaxis
TherapeuticsMetabolic & Endocrinology
GMPCN - NMPA
RegistrationChina
ModalitiesSmall Molecule

Exclusive Summary

  • • Off-patent and absent from US/EU; many Asia/MENA/LATAM markets remain whitespace for first/only entrants.
  • • DPN affects an estimated 160–270 million people globally, driving steady long-term demand.
  • • Listed in Japanese and Chinese guidelines as a disease-modifying option for early DPN, complementary to analgesics.
  • • JP-compliant API with Technology Transfer and Distribution models enables faster registration in JP-accepting markets (Vietnam requires a direct local partner).
  • • Generics typically offer 50–80% price cuts vs. originator, supporting reimbursement and rapid uptake.

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