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
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]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2016/05/02 | Not Applicable | Completed | |||
2014/05/28 | Phase 2 | Withdrawn | |||
2012/09/18 | Phase 1 | Completed | |||
2011/04/01 | Phase 2 | Completed | |||
2010/10/06 | Phase 1 | Completed | |||
2010/07/22 | Phase 1 | Completed | |||
2009/02/09 | Phase 1 | Completed | |||
2008/08/08 | Phase 2 | Completed | |||
2008/04/22 | Phase 1 | Completed | |||
2008/01/28 | Phase 1 | Completed |
FDA Drug Approvals
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No FDA approvals found for this drug. |
EMA Drug Approvals
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No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
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No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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No UK EMC drug information found for this drug. |
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