全球首个NASH新药(OCA,Obeticholic Acid)获批在即,攻克该领域实属不易。除FXR激动剂靶点外,国外其他的还有基于糖脂代谢调节的PPAR激动剂、THRβ激动剂和ACC抑制剂、胆汁酸代谢调节的回肠胆酸转运抑制剂(IBAT)、SSAO抑制剂、ASK1抑制剂、FGF19/21、GLP-1类似物、基于抗炎原理CCR2/5抑制剂等等。
参考:
NMPA/CDE;
药融数据,Pharnex Datamonitor;
FDA/EMA;
相关公司公开披露;
https://www.ncbi.nlm.nih.gov/pubmed/?term=NASH;
https://adisinsight.springer.com/trials/700294651;
https://www.nature.com/articles/s41575-018-0014-9,;
https://www.akerotx.com/nash/;
https://www.evaluate.com/vantage/articles/news/trial-results/genfit-deals-and-conatus-folds-nash-plays;
NGM Bio’s IPO Raises $107M as NASH Drug Continues Clinical Testing;
Nonalcoholic Steatohepatitis with Compensated Cirrhosis:Developing Drugs for Treatment Guidance for Industry,https://www.fda.gov/media/127738/download。等等。
2019:全球NASH在研药物概览 (Pipeline)等等。