Delving into the Latest Updates on Megestrol Acetate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

17-Acetoxy-6-methylpregna-4,6-diene-3,20-dione, 17-Hydroxy-6-methylpregna-4,6-diene-3,20-dione 17-acetate, 17alpha-Acetoxy-6-dehydro-6-methylprogesterone

+ [36]

Target

PR

Mechanism

PR agonists(Progesterone receptor agonists)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesUrogenital Diseases+ [1]

Active Indication

Acquired Immunodeficiency SyndromeSquamous Cell Carcinoma of Head and Neck

Inactive Indication

AnorexiaCachexiaDementia+ [3]

Originator Organization

Bristol Myers Squibb Co.

Active Organization

Endo Operations Ltd.

Changchun Genescience Pharmaceuticals Co., Ltd.

Inactive Organization

Endo Pharmaceuticals, Inc.

Bristol Myers Squibb Co.

Par Pharmaceutical, Inc.

+ [2]

Drug Highest PhaseApproved

First Approval Date

US (18 Aug 1971),

Acquired Immunodeficiency Syndrome

RegulationOrphan Drug (EU)

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Structure/Sequence

Molecular FormulaC24H32O4

InChIKeyRQZAXGRLVPAYTJ-GQFGMJRRSA-N

CAS Registry595-33-5

This study is a prospective, randomized, parallel-controlled clinical trial, with the primary objective to evaluate the efficacy and safety of nano-crystalline megestrol acetate combined with standard treatment compared to standard treatment alone for adjuvant therapy in patients with high-risk squamous cell carcinoma of the head and neck (excluding nasopharyngeal carcinoma) after surgery.

Start Date01 Jan 2025

Sponsor / Collaborator

Changchun Genescience Pharmaceuticals Co., Ltd.

IRCT20230222057495N24

/ RecruitingNot Applicable

Bioequivalence study of megestrol 40 mg tablets from Ati Pharmed Pharmaceutical Company compared to megestrol 160 mg tablets from Meda Pharma Pharmaceutical Company, Spain, on healthy volunteers

Start Date04 Dec 2024

Sponsor / Collaborator-

IRCT20090613002027N23

/ RecruitingPhase 2/3IIT

Evaluation of the safety and efficacy of megestrol acetate plus mirtazapine in combination versus megestrol acetate alone in cachexia induced by GI cancers

Start Date22 Oct 2024

Sponsor / Collaborator

Mazandaran University of Medical Sciences

100 Clinical Results associated with Megestrol Acetate

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100 Translational Medicine associated with Megestrol Acetate

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100 Patents (Medical) associated with Megestrol Acetate

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2,046

Literatures (Medical) associated with Megestrol Acetate

01 Jan 2025·Gynecologic Oncology

Palbociclib plus letrozole in estrogen receptor-positive advanced/recurrent endometrial cancer: Double-blind placebo-controlled randomized phase II ENGOT-EN3/PALEO trial

Article

Author: Redondo, Andrés ; Bjørge, Line ; Petersson, Karen S ; Ginesta, M Pilar Barretina ; Mirza, Mansoor R ; Roed, Henrik ; Luczak, Adam A ; Salutari, Vanda ; Lindemann, Kristina ; Sehouli, Jalid ; Ataseven, Beyhan ; Trillsch, Fabian ; Runnebaum, Ingo B ; Rubio, Maria Jesús ; Auranen, Annika ; Nyvang, Gitte-Bettina ; Marmé, Frederik ; Christensen, René DePont ; Kurtz, Jean-Emmanuel ; Gil-Martin, Marta

PURPOSEThe CDK4/6 inhibitor palbociclib inhibits cyclin A, which is overexpressed in endometrial cancer. Combining palbociclib with endocrine therapy improves efficacy in hormone receptor-positive breast cancer. We investigated palbociclib combined with endocrine therapy for estrogen receptor-positive advanced/recurrent endometrial cancer.PATIENTS AND METHODSThis placebo-controlled double-blind, randomized phase II screening trial (NCT02730429) enrolled women with measurable/evaluable estrogen receptor-positive endometrioid endometrial cancer that was primary metastatic or had relapsed after ≥1 prior systemic therapy. Patients were randomized in a 1:1 ratio, stratified by number of prior chemotherapy lines, measurable versus evaluable non-measurable disease, and prior medroxyprogesterone/megestrol acetate treatment, to receive oral letrozole 2.5 mg on days 1-28 plus either oral palbociclib 125 mg or placebo on days 1-21, repeated every 28 days until disease progression or unacceptable toxicity. The primary end point was investigator-assessed progression-free survival (PFS).RESULTSAmong 77 patients randomized between February 16, 2017, and December 21, 2018, 73 were treated (36 with palbociclib-letrozole, 37 with placebo-letrozole). Median follow-up was 21.9 (95 % CI, 16.7 to 22.3) months. Median PFS was 8.3 (95 % CI, 4.6 to 11.2) versus 3.1 (95 % CI, 2.7 to 6.8) months, respectively. In a landmark analysis at 12 months the PFS hazard ratio was 0.57 (95 % CI, 0.32 to 0.99; P = .044). Grade ≥ 3 adverse events were more common with palbociclib-letrozole (67 %) than placebo-letrozole (30 %), most commonly neutropenia (44 % v 0 %, respectively).CONCLUSIONThese results support a potential role of the palbociclib-letrozole combination as treatment for hormone receptor-positive advanced/recurrent endometrial cancer. Based on these encouraging results, phase III evaluation of letrozole combined with a CDK4/6 inhibitor is planned.CLINICAL TRIAL INFORMATIONNCT02730429.

20 Dec 2024·Medicine

Comparative effectiveness of Korean medicine treatment for idiopathic central precocious puberty: A Bayesian network meta-analysis

Review

Author: Lee, Hye-Lim ; Lee, Hyun-Hee ; Shim, Soo-Bo ; Choi, Eun-Young ; Son, Mi-Ju

Background:The purpose of this study is to analyze the comparative effect of the Korean medicine treatment for idiopathic central precocious puberty (ICPP) using Bayesian network meta-analysis (NMA).Methods:Seventeen electronic databases were used to search for randomized controlled trials (RCTs) that evaluated various Korean medicine treatments for ICPP. R software (version 4.2.3) was used to perform NMA. The risk of bias was assessed using the Risk of Bias 2 tool proposed by the Cochrane Collaboration. The results of NMA were expressed as network map, SUCRA, and Rank plot.Results:A total of 81 RCTs were included in the NMA. The gonadotropin-releasing hormone agonist (GnRHa) was the most effective for growth rate, followed by herbal medicine (HM) combined with GnRHa. The combination of HM and auricular plaster therapy was the most effective in improving the bone age index and ovarian volume, and megestrol was the most effective in improving uterine volume. The combination of HM, auricular plaster therapy and GnRHa was the most effective in improving follicle-stimulating hormone, and the combination of HM and GnRHa was the most effective in improving luteinizing hormone and estradiol.Conclusion:The combination of HM and GnRHa generally showed greater effectiveness compared to GnRHa monotherapy or HM monotherapy. Although there have been few reports of adverse events related to HM, additional research and practical experience are needed. Further diverse studies should be conducted to support the decision-making process of patients and clinicians during the diagnosis and treatment of ICPP.

01 Dec 2024·Gynecologic Oncology

Comparative analysis of hormonal therapy in low-grade endometrial stromal sarcoma: A retrospective study

Article

Author: Frumovitz, Michael ; Ratan, Ravin ; Soliman, Pamela T ; Fleming, Nicole D ; Saab, Reem ; Meyer, Larissa A ; Legarreta, Alejandra Flores ; Fleming, Nicole D. ; Fellman, Bryan M ; Fellman, Bryan M. ; Nassif Haddad, Elise F ; Nassif Haddad, Elise F. ; Meyer, Larissa A. ; Soliman, Pamela T.

OBJECTIVETo evaluate the disease course of patients with low grade endometrial stromal sarcoma (LG-ESS) and compare oncologic outcomes associated with hormonal therapy in primary and recurrent disease.METHODSThis is a retrospective study of patients with LG-ESS who underwent active treatment between January 2000 and July 2023. Recurrence-free survival (RFS) and overall survival (OS) were estimated using the Kaplan-Meier product-limit estimator and modeled via Cox proportional hazards regression.RESULTSA total of 221 patients were included; 58 % of patients (91/157) were stage I, 12 % (19/157) stage II, 13 % (20/157) stage III, and 17 % (27/157) stage IV. Surgery was the primary treatment for 98 % (213/218). Only 79 patients received hormonal adjuvant therapy, 58 % (46/79) Megace, 24 % (19/79) Letrozole, and 18 % (14/79) received other hormonal therapy. There was no significant difference in RFS (p = 0.159) and OS (p = 0.167) between patients receiving Megace versus Letrozole as adjuvant therapy. At first recurrence, patients given Megace had a similar RFS to those on Letrozole (p = 0.302), but a better OS (27 vs 10 months, p = 0.018). Negative status of estrogen, smooth muscle actin, and desmin were associated with lower RFS (p = 0.039, p = 0.002, and p = 0.015, respectively) and OS (p = 0.008, p = 0.012, and p = 0.013, respectively). Lymphovascular invasion was associated with lower RFS (p = 0.033), and negative status of progesterone was associated with lower OS (p = 0.003).CONCLUSIONThere was no difference in oncologic outcomes between Megace and Letrozole in patients who received adjuvant therapy for LG-ESS. Megace may have potential survival advantage in recurrent disease. Further study is warranted to determine the most effective agents and their sequence in the treatment of LG-ESS.

100 Deals associated with Megestrol Acetate

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External Link

KEGG	Wiki	ATC	Drug Bank
D00952	Megestrol Acetate	G03DB02 G03AC05 L02AB01	DB00351

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Acquired Immunodeficiency Syndrome	US	Endo Operations Ltd.	05 Jul 2005

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Squamous Cell Carcinoma of Head and Neck	Phase 3	CN	Changchun Genescience Pharmaceuticals Co., Ltd.	01 Jan 2025
Dementia	Phase 2	ES	Rottapharm Sl	01 Jun 2007
Neoplasms	Phase 2	US	Par Pharmaceutical, Inc.	01 Jun 2006
Anorexia	Phase 2	US	Bristol Myers Squibb Co.	31 Aug 2001
Cachexia	Phase 2	US	Bristol Myers Squibb Co.	31 Aug 2001
HIV Wasting Syndrome	Discovery	ZA	Endo Pharmaceuticals, Inc.	01 Dec 2004
Anorexia	Discovery	US	Bristol Myers Squibb Co.	31 Aug 2001
Cachexia	Discovery	US	Bristol Myers Squibb Co.	31 Aug 2001
Malnutrition	Discovery	US	Bristol Myers Squibb Co.	31 Aug 2001

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05492487 (not provided, Pubmed \| J Assist Reprod Genet)	Phase 2	Endometrioid intraepithelial neoplasia	-	Megestrol Acetate	yomvispsvx(uohexsucsr) = sgygznhsil rcmdxqyser (mhbmpzhkwx ) View more	Positive	31 Aug 2024
				Levonorgestrel-Intrauterine System	yomvispsvx(uohexsucsr) = elywqgkcjw rcmdxqyser (mhbmpzhkwx ) View more
ENDO2024	Not Applicable	Addisonian crisis	-	Megestrol Acetate 400 mg daily	vpzswfhbca(uzifbxamfn) = omydnimwnj bdktxuvdgm (mnoojtkjcc ) View more	-	01 Jun 2024
ASCO2024	Not Applicable	Neoplasms	-	Megestrol Acetate	eeenczlnew(xljekrprsq) = aspekhqyth gpircsqdql (siseixiroo ) View more	-	24 May 2024
SAT319 (ENDO2023)	Not Applicable	Adrenal Insufficiency	-	Megestrol 200mg	(gcdgirpvab) = drpxlzwmnz tyjyctfwkj (otyndlmrto ) View more	-	05 Oct 2023
				Hydrocortisone	ahpddlfwaw(tdkvlbfgcv) = qhzaogplzb aasjjbtscj (tmkorsozhc )
NCT03671811 (ASCO2023)	Phase 2	Endometrial Carcinoma	44	Megestrol acetate + Pterostilbene	dkbqzrthsl(mqyfcoefmd) = fazxbrpgzs dkpcxigjkl (aodyqrqceh )	Positive	31 May 2023
				Megestrol acetate	dkbqzrthsl(mqyfcoefmd) = xxigfrvizv dkpcxigjkl (aodyqrqceh )
NCT02269670 (CTgov)	Phase 2	Breast cancer recurrent \| Hormone receptor positive breast cancer \| PR-positive breast cancer \| HER2-negative breast cancer \| Metastatic breast cancer \| Estrogen receptor positive breast cancer \| Breast Cancer 3	3	Fulvestrant+tamoxifen citrate+Letrozole+megestrol acetate+Everolimus+anastrozole	orydyxrnnc(bwgcngajug) = dtfwjgdpze bskrvsfhkd (jihzgclqpd, uewartilgl - oawwfhydum) View more	-	05 Apr 2022
NCT01968317 (CTgov)	Phase 2	Endometrioid intraepithelial neoplasia \| uterus adenocarcinoma	150	Megestrol acetat+metformin (Megestrol Acetate and Metformin)	tkbfqczxnb(zffbeekqdv) = exicayufqg yuasjptkrl (xjcruxdjwa, unvvlcvdxz - qneuqhftzj) View more	-	13 Sep 2021
				megestrol acetate (Megestrol Acetate)	tkbfqczxnb(zffbeekqdv) = iyvnhxfchw yuasjptkrl (xjcruxdjwa, bcleqfkfuc - wsvavotbop) View more
NCT00503581 (CTgov)	Phase 2	Uterine Corpus Cancer \| Endometrioid intraepithelial neoplasia \| Endometrial Hyperplasia \| Squamous Intraepithelial Lesions	9	Quality-of-Life Assessment+megestrol acetate (Regimen 1 (Megestrol Acetate, Surgery))	gwjsncfihm(tiliibftxo) = zwbmfocumt wkdgzsjwqz (hgudzgizxe, dczjgzzppe - svqlvbhaui) View more	-	14 Oct 2020
				Quality-of-Life Assessment+megestrol acetate (Regimen 2 (Megestrol Acetate, Surgery))	gwjsncfihm(tiliibftxo) = tjlsmqwbnw wkdgzsjwqz (hgudzgizxe, lfemvqoeou - zvoabshqoq) View more
SUN-031 (ENDO2020)	Not Applicable	-	1	Megestrol Acetate 625/5mg	ekeaormzta(fzuvybnyxj) = jyoptsayds hseqpxsnpv (fitvtorhgr ) View more	-	08 May 2020
NCT02595723 (CTgov)	Phase 4	Cognitive Dysfunction \| Amnesia, Anterograde	21	Megestrol 800 mg liquid+Phenytoin 200 mg capsule (Phenytoin, Then Megestrol)	sukrumjwjh(xgbcjpwndv) = itdzekdsor uqcefaxxjo (rumrwgnskc, izogvmqvod - fxmbiyrqbq) View more	-	09 Sep 2019
				Phenytoin-matched Placebo capsule+Megestrol 800 mg liquid (Placebo, Then Megestrol)	sukrumjwjh(xgbcjpwndv) = kgiugoiots uqcefaxxjo (rumrwgnskc, cofvzpbmdq - bystbaymgq) View more