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Acyline

Generic Name
Acyline
Drug Type
Small Molecule
Chemical Formula
C80H102ClN15O14
CAS Number
170157-13-8
Unique Ingredient Identifier
S3439D3B35

Overview

Acyline has been investigated for the prevention and treatment of Hypogonadism and Contraception.

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Research Report

Published: Sep 30, 2025

A Comprehensive Monograph on the Investigational GnRH Antagonist: Acyline (DB11906)

1.0 Executive Summary

Acyline (developmental code name MER-104) is a potent, long-acting, synthetic peptide classified as a third-generation gonadotropin-releasing hormone (GnRH) antagonist.[1] As a small molecule oligopeptide, its primary mechanism of action is the direct, competitive inhibition of the gonadotropin-releasing hormone receptor (GnRHR) located on the anterior pituitary gland.[4] This blockade prevents endogenous GnRH from stimulating the receptor, resulting in an immediate, profound, and sustained suppression of the gonadotropins, luteinizing hormone (LH) and follicle-stimulating hormone (FSH).[6] The subsequent reduction in gonadotropin signaling leads to a rapid decrease in gonadal steroidogenesis, most notably causing serum testosterone levels in males to fall to castrate levels without the initial "flare" effect characteristic of GnRH agonists.[5]

The clinical development program for Acyline was ambitious, with male hormonal contraception as its lead indication, reaching Phase 3 clinical trials.[2] Its potent and long-lasting effect, with a single subcutaneous injection capable of suppressing testosterone for over two weeks, made it a promising candidate for a convenient, long-acting male contraceptive regimen.[7] The compound was also explored in Phase 2 trials for a range of other hormone-dependent conditions, including advanced prostate cancer, androgen deficiency, precocious puberty, and metabolic disorders such as Type 2 diabetes mellitus and obesity.[2]

Continue reading the full research report

FDA Drug Approvals

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EMA Drug Approvals

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HSA Drug Approvals

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NMPA Drug Approvals

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PPB Drug Approvals

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TGA Drug Approvals

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Health Canada Drug Approvals

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CIMA AEMPS Drug Approvals

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No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

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No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

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No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

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UK EMC Drug Information

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