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Also known as NBI-56418 (GnRH antagonist)
NBI-56418 · 1 trial · 1 indication
This scale is used to assess the signs (pelvic tenderness and induration) and symptoms (nonmenstrual pelvic pain, dysmenorrhea and dyspareunia) associated with endometriosis.
| Arm | Type | Description |
|---|---|---|
| placebo | PLACEBO_COMPARATOR | - |
| NBI-56418 75 mg | EXPERIMENTAL | - |
| NBI-56418 150 mg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| NBI-56418 (GnRH antagonist) | DRUG | - |
| placebo | DRUG | - |
Inclusion Criteria * Be female, aged 18 to 49 years, inclusive. * Have pelvic pain and dysmenorrhea resulting in a Composite Pelvic Sign and Symptoms Score (CPSSS) of ≥ 6. * Have had a diagnosis of endometriosis made following laparoscopic visualization of the disease within the last 5 years of the...
NBI-56418 is an investigational small molecule being studied for the treatment of endometriosis. It has completed a Phase 2 clinical trial in women with this condition. Endometriosis is a chronic gynecologic disorder in which tissue similar to the uterine lining grows outside the uterus. NBI-56418 has not been approved for any indication.
NBI-56418 is a gonadotropin-releasing hormone (GnRH) antagonist. It works by blocking GnRH receptors, which reduces the production of sex hormones such as estrogen. Because endometriosis is estrogen-dependent, lowering estrogen levels may help reduce symptoms. This mechanism is described in the drug's alternative name, NBI-56418 (GnRH antagonist).
NBI-56418 is being developed by Abbott Laboratories, which trades under the ticker symbol ABT. Abbott is the sponsor of the clinical program for this drug candidate.
NBI-56418 is in Phase 2 development. It has completed one Phase 2 clinical trial in endometriosis. The drug is investigational and has not been approved by the FDA or any other regulatory agency for any indication.
NBI-56418 has been studied in one completed Phase 2 trial, NCT00109512, titled "Endometriosis Trial: Study of NBI-56418 in Endometriosis." The trial enrolled 76 female participants aged 18 years and older in the United States. It was randomized, double-blind, and placebo-controlled.
Yes, NBI-56418 (GnRH antagonist) is an alternative name for NBI-56418. The parenthetical describes the drug's mechanism as a gonadotropin-releasing hormone antagonist. Both names refer to the same investigational compound being developed by Abbott Laboratories for endometriosis.