OG-6219 / Organon - LARVOL DELTA

Preclinical characterization of a highly potent and selective HSD17B1 inhibitor for the treatment of endometriosis (ENDO 2025) - "All these data warrants GenSci146 a promising preclinical candidate and the IND filing is expected in early 2026.*. .*"

Preclinical • Endometriosis • Gynecology • Women's Health

ELENA: A 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 Pain (clinicaltrials.gov) - P2 | N=380 | Active, not recruiting | Sponsor: Organon and Co | Trial completion date: Dec 2024 ➔ May 2025 | Trial primary completion date: Dec 2024 ➔ May 2025

Trial completion date • Trial primary completion date • Endometriosis • Gynecology • Pain • Women's Health

ELENA: A 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 Pain (clinicaltrials.gov) - P2 | N=380 | Active, not recruiting | Sponsor: Organon and Co | Recruiting ➔ Active, not recruiting

Enrollment closed • Endometriosis • Gynecology • Pain • Women's Health

ELENA: A 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 Pain (clinicaltrials.gov) - P2 | N=380 | Recruiting | Sponsor: Organon and Co | Phase classification: P ➔ P2

Phase classification • Endometriosis • Gynecology • Pain • Women's Health

A Proof-of-concept / Dose-range Study of OG-6219, a HSD17beta1 Enzyme Inhibitor, in Participants with Moderate to Severe Endometriosis-Related Pain. (WCE 2023) - No abstract available

Endometriosis • Gynecology • Pain • Women's Health

Initial Clinical Experience with OG-6219, a Hydroxysteroid (17-beta) Dehydrogenase 1 (HSD17β1) Inhibitor for Treatment of Endometriosis. (SRI 2023) - "OG-6219 is a novel reversible inhibitor of HSD17B1 that may allow an alternative strategy for controlling endometriosis."

Clinical • Endometriosis • Gynecology • Pain • Women's Health

ELENA: A 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 Pain (clinicaltrials.gov) - P2a/b | N=380 | Recruiting | Sponsor: Organon and Co | Not yet recruiting ➔ Recruiting

Enrollment open • Endometriosis • Gynecology • Pain • Women's Health

Organon Reports Results for the Third Quarter Ended September 30, 2022 (Yahoo News) - "Organon...announced its results for the third quarter ended September 30, 2022....'Further, last week we enrolled the first patient in the Phase 2 ELENA study to evaluate the safety and efficacy of OG-6219, the investigational candidate for endometriosis we acquired with Forendo Pharma last year."

Enrollment open • Endometriosis • Women's Health

Organon Completes Acquisition of Forendo Pharma (Businesswire) - "Organon...announced the completion of its acquisition of Forendo Pharma, a clinical-stage drug development company focused on novel treatments in women’s health. Forendo’s lead candidate, FOR-6219, is an investigational, potentially first-in-class oral 17β-hydroxysteroid dehydrogenase type 1...Consideration for the transaction includes a $75 million upfront payment, assumption of approximately $9 million of Forendo debt, payments upon the achievement of certain development and regulatory milestones of up to $270 million and commercial milestones payments of up to $600 million, which together could amount to total consideration of $954 million..."

M&A • Endometriosis • Women's Health

Organon to Acquire Forendo Pharma (Businesswire) - "Organon...and Forendo Pharma today announced that the companies have entered into a definitive agreement, under which Organon will acquire Forendo....Its lead clinical compound is an investigational, potentially first-in-class oral 17β-hydroxysteroid dehydrogenase type 1 (HSD17B1) inhibitor in early clinical development for endometriosis, being evaluated for its potential effect on endometriotic lesions....Consideration for the transaction includes a $75 million upfront payment, assumption of approximately $9 million of Forendo debt, payments upon the achievement of certain development and regulatory milestones of up to $270 million and commercial milestones payments of up to $600 million, which together could amount to total consideration of $954 million....The transaction is expected to close in December 2021."

M&A • Endometriosis • Women's Health

A Relative Bioavailability Study of FOR-6219 in Capsule and Tablet Formulations (clinicaltrials.gov) - P1; N=12; Completed; Sponsor: Forendo Pharma Ltd; Active, not recruiting ➔ Completed

Clinical • Trial completion

A Relative Bioavailability Study of FOR-6219 in Capsule and Tablet Formulations (clinicaltrials.gov) - P1; N=12; Active, not recruiting; Sponsor: Forendo Pharma Ltd; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

A Relative Bioavailability Study of FOR-6219 in Capsule and Tablet Formulations (clinicaltrials.gov) - P1; N=12; Recruiting; Sponsor: Forendo Pharma Ltd

Clinical • New P1 trial

A Study to Investigate the Safety, Tolerability, Food Effect, Pharmacokinetics and Pharmacodynamics of FOR-6219 (clinicaltrials.gov) - P1; N=87; Completed; Sponsor: Forendo Pharma Ltd; Recruiting ➔ Completed

Clinical • Trial completion • Endometriosis • Gynecology

A Study to Investigate the Safety, Tolerability, Food Effect, Pharmacokinetics and Pharmacodynamics of FOR-6219 (clinicaltrials.gov) - P1; N=87; Recruiting; Sponsor: Forendo Pharma Ltd; Trial completion date: Jun 2020 ➔ Dec 2020; Trial primary completion date: Jun 2020 ➔ Dec 2020

Clinical • Trial completion date • Trial primary completion date • Endometriosis • Gynecology

A Study to Investigate the Safety, Tolerability, Food Effect, Pharmacokinetics and Pharmacodynamics of FOR-6219 (clinicaltrials.gov) - P1; N=87; Recruiting; Sponsor: Forendo Pharma Ltd; Trial completion date: Nov 2019 ➔ Jun 2020; Trial primary completion date: Nov 2019 ➔ Jun 2020

Clinical • Trial completion date • Trial primary completion date

Blocking 17b-hydroxysteroid dehydrogenase type 1 in endometrial cancer: a potential novel endocrine therapeutic approach (ESGO 2019) - "Conclusion In conclusion, HSD17B1 inhibition efficiently blocks the generation of E2 from E1 using various EC models. Further preclinical investigations and HSD17B1 inhibitor development to make candidate compounds suitable for the first human studies are awaited."