Two Potential Upcoming Approvals and Other January NDAs

Our latest roundup of small molecules in the news includes two potential upcoming approvals:


Rezafungin (CD-101) is a once-weekly IV antifungal agent and next-generation echinocandin (glucan synthase inhibitor) that demonstrated non-inferiority vs. standard of care caspofungin (IV QD) (NCT03667690). An FDA AdCom voted 14 to 1 in favor that Cidara (CDTX) showed enough evidence to support limited use of rezafungin for treating fungal infections (candidemia + invasive candidiasis) in patients with limited treatment options. The molecule was optimized to be more metabolically stable, allowing for extended half-life and potentially improved safety due to lack of a reactive metabolite observed in past echinocandins. 


This oral, once daily (12.5-25 mg) dual endothelin receptor (ETR) antagonist with antihypertensive activity. Idorsia filed an NDA with data from a Ph. III (NCT03541174) study in resistant hypertension showing efficacy in reducing blood pressure compared to placebo at 4-weeks. The drug was well-tolerated and showed sustained blood pressure reduction over 48-weeks. The drug is an active metabolite of the anti-hypertensive agent and dual ETR antagonist from Janssen, macitentan (Opsumit). Both molecules block endothelium isoform-1 (ET-1), a potent vasoconstrictor, binding to type-A and type-B ETR on endothelial cells. Janssen Biotech will continue Ph. III development of aprocitentan, for this collaboration that began in 2017.

In our full update of small molecules in the news we also cover recent:

  • (B)Million Dollar Molecules: recent mergers and acquisitions
  • Molecules in Motion: clinical trial updates and FDA filings
  • Molecules of the Month – Where Are They Now?: updates on past Drug Hunter MotM
  • Potential upcoming approvals: recent NDA filings and upcoming PDUFA dates

Read about all 14 molecules in the full Premium article here.

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