Delving into the Latest Updates on Linustedastat with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

FOR-6219, OG-6219

Target

17β-HSD1

Action

inhibitors

Mechanism

17β-HSD1 inhibitors(Estradiol 17-beta-dehydrogenase 1 inhibitors)

Therapeutic Areas

Nervous System DiseasesUrogenital DiseasesOther Diseases

Active Indication

EndometriosisPelvic Pain

Inactive Indication-

Originator Organization

Forendo Pharma Oy

Active Organization

Organon & Co.

Forendo Pharma Oy

Inactive Organization-

License Organization

Forendo Pharma OyOrganon NV

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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Structure/Sequence

Molecular FormulaC26H29F2N3O2

InChIKeyRMMVCLGAUPAFAI-MLXDORPZSA-N

CAS Registry2254299-48-2

This is a phase 1, randomised, open-label, three-way, three-period, crossover relative bioavailability study to assess the single-dose pharmacokinetics of FOR-6219 in capsule and tablet formulations in postmenopausal women. The effect of high-fat food on the pharmacokinetics of the tablet formulation will also be evaluated. A total of twelve, post-menopausal women, will be randomised to receive a single oral dose of FOR-6219 in three treatment periods: capsule formulation (fasted); tablet formulation (fed); tablet formulation (fasted)

Start Date10 Dec 2020

Sponsor / Collaborator

Forendo Pharma Oy

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100 Clinical Results associated with Linustedastat

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100 Translational Medicine associated with Linustedastat

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100 Patents (Medical) associated with Linustedastat

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15

News (Medical) associated with Linustedastat

02 Jul 2025

·pipelinereview.com

Organon Provides Update on Phase 2 ELENA Proof-of-Concept Study Evaluating OG-6219 in Patients with Endometriosis-Related Pain

JERSEY CITY, NJ, USA I July 02, 2025 I Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, today announced that the Phase 2 ELENA proof-of-concept study evaluating the investigational candidate OG-6219 in endometriosis-related pain did not meet its primary efficacy endpoint. OG-6219 is an oral 17β-hydroxysteroid dehydrogenase type 1 (HSD17B1) inhibitor, which Organon acquired through its acquisition of Forendo Pharma in 2021. In the study, OG-6219 did not demonstrate improvement in moderate-to-severe endometriosis-related overall pelvic pain compared to placebo. Based on these results, the company plans to discontinue the OG-6219 clinical development program. “While these study results are disappointing, Organon remains committed to our long-term vision to create a better and healthier every day for all women including those living with endometriosis,” said Juan Camilo Arjona Ferreira, M.D., Head of Research & Development and Chief Medical Officer at Organon. “We are grateful to all the patients, caregivers, and investigators for their participation in and support of this study.” The randomized, double-blind, placebo-controlled, parallel-group, global multi-center Phase 2a/b study ( NCT05560646 ) aimed to evaluate the efficacy, safety, and tolerability of three dose levels of OG-6219 in pre-menopausal women 18 to 49 years of age who have been surgically diagnosed with endometriosis with moderate-to-severe endometriosis-related pain. Eligible patients were randomized to receive one of three doses of OG-6219 or placebo orally twice a day. The primary efficacy endpoint was the change from the baseline cycle (placebo run-in cycle) to the last planned treatment cycle (third month of treatment exposure), in the mean endometriosis-related overall pelvic pain score (measured using an eleven-point numerical rating scale). About Organon Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women’s Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 markets. Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at www.organon.com and follow us on LinkedIn , Instagram , X , YouTube , TikTok and Facebook . SOURCE: Organon

Phase 2Clinical ResultAcquisition

02 Jul 2025

·www.fiercebiotech.com

Organon axes \'biggest potential opportunity\' after flunking phase 2 trial

Ending development of its endometriosis prospect is a blow to Organon’s attempts to launch new growth drivers.\n A drug candidate Organon hailed as perhaps its “biggest potential opportunity” has flunked a phase 2 trial, prompting the company to end clinical development of the endometriosis prospect.Women’s health specialist Organon picked up the candidate, OG-6219, in its buyout of Forendo Pharma. Seeking to build a R&D pipeline after spinning out of Merck & Co., Organon paid $75 million upfront to acquire the company in 2021 and started a phase 2 trial the next year. Investigators randomized 354 premenopausal women with moderate to severe endometriosis-related pain to receive one of three doses of OG-6219 or placebo. Organon was betting that OG-6219 would reduce pain by inhibiting production of a hormone that regulates the growth of uterine tissue and can cause inflammation.The bet failed. Organon found OG-6219 was no better than placebo at reducing endometriosis-related overall pelvic pain, causing the study to miss its primary endpoint. The company responded by stopping clinical development of OG-6219. The development is a blow to Organon’s attempts to launch new growth drivers to support the approved drugs the company inherited from Merck. Talking on an earnings call in February, Juan Camilo Ferreira, M.D., head of R&D at Organon, called (PDF) OG-6219 “perhaps the biggest potential opportunity we have.”There may still be an opportunity for Organon to generate a return on the Forendo buyout. On the February call, Ferreira said the company had a backup program for OG-6219, “which supports our goal to deliver a product based on this novel mechanism.” Organon made no mention of the backup program in its statement about the failure of the study and discontinuation of OG-6219.Whatever happens to the backup program, the failure of OG-6219 will set back Organon’s aspirations to deliver a new nonhormonal treatment option for endometriosis. The company was planning to start a phase 3 program next year with a view to launching the product by the end of the decade.

$Organon axes \'biggest potential opportunity\' after flunking phase 2 trial$

Phase 2Phase 3Acquisition

02 Jul 2025

·firstwordpharma.com

Organon's non-hormonal endometriosis hope dashed

Organon said Wednesday it will discontinue development of its experimental endometriosis treatment OG-6219 after the drug failed to demonstrate superior pain relief compared to placebo in a Phase II trial. The decision marks a setback for the women's health specialist, which acquired the asset through its Forendo Pharma takeout in 2021 for up to $954 million.The ELENA study enrolled 354 pre-menopausal women ages 18 to 49 with surgically diagnosed endometriosis and moderate-to-severe pelvic pain. Patients were randomised to one of three dose levels of OG-6219 or placebo twice daily for approximately 16 weeks. The primary endpoint measured changes in endometriosis-related overall pelvic pain scores from baseline to the third month of treatment using an 11-point numerical rating scale."While these study results are disappointing, Organon remains committed to our long-term vision to create a better and healthier every day for all women including those living with endometriosis," said Juan Camilo Arjona Ferreira, head of R&D and chief medical officer at the Merck & Co. spinout, in a company release Wednesday.OG-6219, an oral inhibitor of the HSD17B1 enzyme, is designed to selectively reduce local oestrogen production in endometrial tissue and endometriotic lesions without suppressing systemic hormone levels. The mechanism was intended to address limitations of current therapies, which can cause bone density loss and menopausal symptoms, while potentially enabling longer-term use.During Organon's February earnings call, executives had expressed high expectations for the programme. CEO Kevin Ali described OG-6219 as having "the potential to be game-changing," while Ferreira called it "perhaps the biggest potential opportunity we have," projecting it could become "a new non-hormonal treatment option for endometriosis by the end of the decade." The company had planned to initiate Phase III testing in 2026.Ferreira also mentioned during the call that the company had "a backup programme, which supports our goal to deliver a product based on this novel mechanism." However, Wednesday's announcement made no reference to this backup programme or alternative development paths for OG-6219.Forendo had been exploring a preclinical compound targeting HSD17B5 for polycystic ovary syndrome, and aside from women's health, it also had a collaboration with Novartis to use its HSD17B platform in chronic liver diseases.

Phase 2Acquisition

100 Deals associated with Linustedastat

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pelvic Pain	Phase 2	United States	Organon & Co.	25 Oct 2022
Pelvic Pain	Phase 2	Belgium	Organon & Co.	25 Oct 2022
Pelvic Pain	Phase 2	Bulgaria	Organon & Co.	25 Oct 2022
Pelvic Pain	Phase 2	Czechia	Organon & Co.	25 Oct 2022
Pelvic Pain	Phase 2	France	Organon & Co.	25 Oct 2022
Pelvic Pain	Phase 2	Germany	Organon & Co.	25 Oct 2022
Pelvic Pain	Phase 2	Hungary	Organon & Co.	25 Oct 2022
Pelvic Pain	Phase 2	Italy	Organon & Co.	25 Oct 2022
Pelvic Pain	Phase 2	Latvia	Organon & Co.	25 Oct 2022
Pelvic Pain	Phase 2	Poland	Organon & Co.	25 Oct 2022

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05560646 (ELENA, PipelineReview) Manual	Phase 2	Endometriosis \| Pain	-	OG-6219	jknuvaptsz(ameoiivgql) = OG-6219 did not demonstrate improvement in moderate-to-severe endometriosis-related overall pelvic pain compared to placebo. tjounnxmba (rwlcbjmkut ) Not Met	Negative	02 Jul 2025
				Placebo