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NBI-6024 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 Experimental | ACTIVE_COMPARATOR | NBI-6024 0.1 mg |
| 2 Experimental | ACTIVE_COMPARATOR | NBI-6024 0.5 mg |
| 3 Experimental | ACTIVE_COMPARATOR | NBI-6024 1 mg |
| 4 placebo | NO_INTERVENTION | Placebo injection |
| Name | Type | Description |
|---|---|---|
| NBI-6024 | DRUG | 0.1, 0.5 or 1 mg NBI-6024 First 3 doses every 2 weeks. Remaining doses given monthly. Total duration of dosing 24 months. Placebo controlled. |
Inclusion Criteria: * Male or female between the age of 12 and 35 years, inclusive (changed to between the age of 10 and 35 years, inclusive, under Amendment 2) * If female of childbearing potential, patient must use an acceptable method of birth control prior to and for 30 days post study * Adult ...
NBI-6024 is an investigational small molecule being developed for the treatment of Type 1 Diabetes Mellitus. It is intended for adult and adolescent patients with new onset of the disease. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
NBI-6024 is being developed by Neurocrine Biosciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol NBIX. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy for Type 1 Diabetes Mellitus.
NBI-6024 is in Phase 1 clinical development. One Phase 1 trial has been completed, involving 188 participants. The drug remains investigational and has not received FDA approval. It is being studied in adult and adolescent patients with new onset of Type 1 Diabetes Mellitus.
NBI-6024 has one completed clinical trial, registered as NCT00873561. This Phase 1 study evaluated the drug in adult and adolescent patients with new onset of Type 1 Diabetes Mellitus. The trial was randomized, double-blind, and active-controlled, enrolling 188 participants across multiple countries including Canada, Czechia, Finland, France, Germany, South Africa, Spain, and the United Kingdom.
No, NBI-6024 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. A completed Phase 1 trial has evaluated its use in Type 1 Diabetes Mellitus, but the drug has not yet received regulatory approval for any indication.