Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
OG-6219 · 1 trial · 1 indication
Participants completed eDiary items for severity of their pain over the last 24 hours on 11-point NRS for dysmenorrhea or NMPP, and dyspareunia. Each item of the NRS pain severity score ranged from 0 (no pain) to 10 (worst pain imaginable), where lower score indicated a better outcome. The mean OPP score was derived by the pain score for the dysmenorrhea and NMPP items, and score ranged from 0 (no pain) to 10 (worst pain imaginable), where lower score indicated a better outcome. Baseline cycle OPP score was defined as the average daily OPP during baseline cycle.
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant administered an investigational product and which does not necessarily have a causal relationship with this treatment. An SAE was defined as any AE that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. TEAEs were defined as events that first occur or worsen (increase in severity) after the first dose of study drug, during the treatment period, and up to 14 days (inclusive) after the last dose of study drug administration. Percentages are rounded off to the hundredth decimal place.
An AE was defined as any untoward medical occurrence in a clinical study participant administered an investigational product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as events that first occur or worsen (increase in severity) after the first dose of study drug, during the treatment period, and up to 14 days (inclusive) after the last dose of study drug administration. The TEAEs leading to permanent discontinuation of study drug was identified by using the 'Action taken with study treatment' variable equal to 'Drug withdrawal' from the AE page of the electronic case report form. Percentages are rounded off to the hundredth decimal place.
| Arm | Type | Description |
|---|---|---|
| Group A: OG-6219 Dose 1 | EXPERIMENTAL | Group A: OG-6219 Dose 1 BID |
| Group B: OG-6219 Dose 2 | EXPERIMENTAL | Group B: OG-6219 Dose 2 BID |
| Group C: OG-6219 Dose 3 | EXPERIMENTAL | Group C: OG-6219 Dose 3 BID |
| Group D: Placebo | PLACEBO_COMPARATOR | Group D: Placebo BID |
| Name | Type | Description |
|---|---|---|
| OG-6219 | DRUG | OG-6219 Dose 1, Dose 2, Dose 3 BID: Participants will receive (orally) OG-6219 tablets during treatment cycles. |
| Placebo | DRUG | Participants will receive (orally) OG-6219 Placebo tablets BID during treatment cycles. |
Inclusion Criteria: * Pre-menopausal females of age 18 to 49 years old (inclusive) at the time of signing Informed Consent (V1). * Surgically (laparoscopy or laparotomy) diagnosed with endometriosis * Moderate to severe endometriosis-related pelvic pain * Regular menstrual cycles * Is not expected ...
OG-6219 is an investigational small molecule developed by Organon & Co. for endometriosis. It is designed to inhibit HSD17B1, an enzyme involved in estrogen production, and has been studied in a Phase 2 clinical trial for moderate to severe endometriosis-related pain.
OG-6219 is being developed for the treatment of endometriosis, specifically for moderate to severe endometriosis-related pain. It is not approved for any indication and remains an investigational therapy.
OG-6219 targets HSD17B1, an enzyme that catalyzes the conversion of estrone to estradiol. By inhibiting this enzyme, OG-6219 is intended to reduce local estrogen production, which may help alleviate endometriosis-related pain.
OG-6219 is developed by Organon & Co., a pharmaceutical company traded on the New York Stock Exchange under the ticker OGN.
OG-6219 is in Phase 2 clinical development. A Phase 2 trial has been completed, but the drug has not been approved by the FDA or any regulatory agency.
OG-6219 has been evaluated in a completed Phase 2 trial, NCT05560646, which studied three dose levels of OG-6219 taken twice daily versus placebo in women aged 18 to 49 with moderate to severe endometriosis-related pain. The trial enrolled 354 participants across multiple countries.