Curacle Registers Innovative Anticancer Drug Q901 Under International Nonproprietary Name "Mocaciclib"

On May 12, Curacle, an innovative new drug company, announced that the international nonproprietary name (INN) for its CDK7 inhibitor anticancer agent Q901 has been confirmed as "mocaciclib."

The World Health Organization (WHO) has officially assigned "mocaciclib" as the INN for Q901, and the same name has also been approved by the United States Adopted Names (USAN) Council.

An international nonproprietary name is a global standard that allows a substance to be identified by the same name worldwide. It is an essential procedure for global drug approval and business development, and is used in regulatory documents, clinical trials, and academic presentations. Going forward, products containing this ingredient will use "mocaciclib" as the generic name.

Mocaciclib is an innovative new drug that Curacle introduced from the Max Planck Institute in Germany in 2015 and optimized from the early research stage to have high selectivity for CDK7. With a mechanism of inhibiting CDK7, a key enzyme in the cell cycle and transcription, mocaciclib is a leading drug among competitors with similar mechanisms, and is currently being evaluated for safety and efficacy in a phase 1 clinical trial involving patients with various solid tumors.

Curacle is newly elucidating the function and pharmacological efficacy of the CDK7 protein through the high selectivity of mocaciclib. Recently, the company confirmed that CDK7 inhibition by mocaciclib can overcome mechanisms of resistance and non-response to ADCs, and based on this, is actively engaging in discussions with global ADC developers.

Nam Kiyoun, CEO of Curacle, said, "It is common practice for the registration of an international nonproprietary name to occur once some of the risks associated with a drug candidate have been addressed through clinical trials," adding, "The timing of mocaciclib's generic name registration seems appropriate." He continued, "Interest in the novel mechanism demonstrated by mocaciclib is increasing, and positive safety data are emerging from the phase 1 clinical trial. We have high expectations for the commercial potential of mocaciclib."