HLD-0915 | MedDataX

Drug Profile

HLD-0915 is a lead development candidate from Halda Therapeutics for metastatic castration-resistant prostate cancer (mCRPC). It is an oral bifunctional small-molecule RIPTAC therapeutic in first-in-human Phase 1/2 clinical testing. The program has FDA Fast Track designation, indicating accelerated development support rather than market approval.

Drug Class: Bifunctional small-molecule RIPTAC therapeutic
Approval Status: Investigational candidate in Phase 1/2 trial; has FDA Fast Track designation and is not stated as approved.
Mechanism of Action: Forms a ternary complex by holding androgen receptor with an essential effector protein to create neomorphic protein-protein interactions and antitumor effects.

Indications

\Metastatic castration-resistant prostate cancer (mCRPC)\

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Related Clinical Trials

NCT ID	Title	Status	Phase
NCT06800313	A Study of HLD-0915 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)	RECRUITING	PHASE1/PHASE2