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1 products found

pp-131

Capsules

Dossier type
CTD
Dossier status
Under development
Country of origin
United States
GMP approvals
FDA
Comments
Indication: Platinum-resistant ovarian cancer (combination with nab-paclitaxel); Cushing's syndrome Clinical stage: Phase 3 — ROSELLA (ovarian, NDA under review); Phase 3 GRACE (Cushing's syndrome) Modality: Small molecule Mechanism / Target: Selective glucocorticoid receptor (GR) modulator — blocks cortisol-driven GR signalling that promotes chemotherapy resistance; does not inhibit progesterone receptor Route / form: Oral capsule (once daily) Differentiation: Addresses GR-mediated chemo-resistance mechanism unique to ovarian cancer; no PR activity (safer hormonal profile); best-in-class GR selectivity vs mifepristone
Manufacturer #4727

Commercial-stage company specialising in glucocorticoid receptor modulation for oncology and endocrine disorders. Holds first-mover advantage with approved GR antagonist and next-generation wholly owned pipeline. Independent US-focused development and commercialisation strategy.
 

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