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OG-6219

Phase 2

Endometriosis | Small molecule | Other |Organon & Co.|Last Updated: May 8, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment354
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05560646A Study to Investigate Efficacy and Safety of OG-6219 BID in 3 Dose Levels Compared With Placebo in Participants Aged 18 to 49 With Moderate to Severe Endometriosis-related PainPHASE2 COMPLETED 354 — — Oct 25, 2022May 28, 2025May 8, 202686 United States, Belgium +9
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Study Endpoints
Primary Endpoints
Change From Baseline Cycle in Mean Overall Pelvic Pain Score at Treatment Cycle 3
Baseline Cycle (up to Day -28) and Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).

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.

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
From the first dose administration of the study drug (Day 1) up to 14 days after the last dose of study drug administration, approximately 108 days

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.

Percentage of Participants With Treatment-Emergent Adverse Events Leading to Study Treatment Discontinuation
From the first dose administration of the study drug (Day 1) up to 14 days after the last dose of study drug administration, approximately 108 days

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.

Secondary Endpoints
Change From Baseline Cycle in Mean Dysmenorrhea Score at Treatment Cycle 3
Baseline Cycle (up to Day -28) and Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
Change From Baseline Cycle in Mean Non-Menstrual Pelvic Pain Score at Treatment Cycle 3
Baseline Cycle (up to Day -28) and Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
Change From Baseline Cycle in Mean Dyspareunia Score at Treatment Cycle 3
Baseline Cycle (up to Day -28) and Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Group A: OG-6219 Dose 1EXPERIMENTALGroup A: OG-6219 Dose 1 BID
Group B: OG-6219 Dose 2EXPERIMENTALGroup B: OG-6219 Dose 2 BID
Group C: OG-6219 Dose 3EXPERIMENTALGroup C: OG-6219 Dose 3 BID
Group D: PlaceboPLACEBO_COMPARATORGroup D: Placebo BID
Interventions
NameTypeDescription
OG-6219DRUGOG-6219 Dose 1, Dose 2, Dose 3 BID: Participants will receive (orally) OG-6219 tablets during treatment cycles.
PlaceboDRUGParticipants will receive (orally) OG-6219 Placebo tablets BID during treatment cycles.
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Eligibility Criteria
Age Range18 Years — 49 Years
SexFEMALE
Healthy VolunteersNo
Study Sites86

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 ...

Countries:United StatesBelgiumBulgariaCzechiaFranceGermanyHungaryItalyLatviaPolandSweden
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Recent Changes (Last 90 Days)
MEDIUMJun 8, 2026NCT05560646TRIAL_REMOVED: changed
MEDIUMJun 8, 2026NCT05560646TRIAL_REMOVED: changed
MEDIUMJun 8, 2026NCT05560646TRIAL_REMOVED: changed
MEDIUMJun 8, 2026NCT05560646TRIAL_REMOVED: changed
MEDIUMJun 8, 2026NCT05560646TRIAL_REMOVED: changed