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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