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NBIP-01435 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part 1: NBIP-01435 | EXPERIMENTAL | Participants will receive NBIP-01435 administered once a week (QW) subcutaneously (SC) for a minimum of 8 weeks. |
| Part 2: NBIP-01435 | EXPERIMENTAL | Participants will receive NBIP-01435 administered SC for a minimum of 8 weeks. |
| Name | Type | Description |
|---|---|---|
| NBIP-01435 | DRUG | NBIP-01435 will be administered per schedule specified in the arm description. |
Key Inclusion Criteria: * Medically confirmed diagnosis of classic 21-hydroxylase deficiency (21-OHD) CAH, based on standard, medically accepted criteria. * Stable glucocorticoid (GC) dose regimen for classic CAH for a minimum of 30 days before screening. * If treated with fludrocortisone, the dose...
NBIP-01435 is an investigational small molecule being developed for the treatment of classic congenital adrenal hyperplasia (CAH) in adults. It is not yet approved for any indication and remains in clinical development. Neurocrine Biosciences is evaluating it for its potential to address the underlying hormonal dysregulation associated with CAH.
NBIP-01435 targets the CRF1 receptor, a class of receptor involved in the regulation of the hypothalamic-pituitary-adrenal axis. By acting on CRF1, the drug is designed to modulate the hormonal pathways that drive excess androgen production in congenital adrenal hyperplasia. It is a small molecule therapeutic.
NBIP-01435 is being developed by Neurocrine Biosciences, Inc., which trades on the Nasdaq under the ticker symbol NBIX. The company is the sole sponsor of the clinical program for this asset in congenital adrenal hyperplasia.
NBIP-01435 is in Phase 2 clinical development. The program has one active trial that has not yet begun recruiting participants. No Phase 3 trials or regulatory approvals have been announced for this drug.
NBIP-01435 is being studied in a single Phase 2 trial, NCT07850739, titled "Efficacy, Safety, Tolerability, and Pharmacokinetics of NBIP-01435 in Adult Participants With Classic Congenital Adrenal Hyperplasia (CAH)." The trial is not yet recruiting and is expected to enroll 36 adults. It is a randomized, controlled study.