Delving into the Latest Updates on Dydrogesterone with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

(9β,10α)-pregna-4,6-diene-3,20-dione, 10α-Isopregnenone, 6-Dehydro-retro-progesterone

+ [19]

Target

PR

Action

agonists

Mechanism

PR agonists(Progesterone receptor agonists)

Therapeutic Areas

Nervous System DiseasesUrogenital DiseasesOther Diseases

Active Indication

Uterine HemorrhageAbortion, HabitualAbortion, Threatened+ [6]

Inactive Indication

Infertility, Female

Originator Organization

Philips-Duphar

Active Organization

Viatris Pharmaceutical GKAbbott Healthcare Products BV

Solvay SA

+ [1]

Inactive Organization

Abbott LaboratoriesAbbott Products LLC

Solvay Pharmaceuticals, Inc.

+ [1]

License Organization

Theramex HQ U.K Ltd.

Viatris, Inc.

Drug Highest PhaseApproved

First Approval Date

United Kingdom (01 Jan 1961),

EndometriosisMenstruation Disturbances

Regulation-

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Structure/Sequence

Molecular FormulaC21H28O2

InChIKeyJGMOKGBVKVMRFX-HQZYFCCVSA-N

CAS Registry152-62-5

主要研究目的研究空腹和餐后状态下单次口服受试制剂地屈孕酮片（规格：10mg，四川科伦药业股份有限公司生产，武汉九珑人福药业有限责任公司提供）与参比制剂地屈孕酮片（商品名：达芙通®，规格：10mg，Abbott Biologicals B.V.生产，Abbott B.V.持证）在中国健康女性受试者体内的药代动力学，评价两制剂生物等效性。次要研究目的评价中国健康女性受试者空腹和餐后单次口服受试制剂（T）地屈孕酮片和参比制剂（R）地屈孕酮片（达芙通®）后的安全性。

[Translation]

Main study objectives To study the pharmacokinetics of the test preparation Dydrogesterone Tablets (Specification: 10 mg, produced by Sichuan Kelun Pharmaceutical Co., Ltd., provided by Wuhan Jiulong Renfu Pharmaceutical Co., Ltd.) and the reference preparation Dydrogesterone Tablets (trade name: Daphaston®, specification: 10 mg, produced by Abbott Biologicals B.V., licensed by Abbott B.V.) in healthy Chinese female subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations. Secondary study objectives To evaluate the safety of the test preparation (T) Dydrogesterone Tablets and the reference preparation (R) Dydrogesterone Tablets (Daphaston®) in healthy Chinese female subjects after a single oral administration in the fasting and fed state.

Start Date03 Jun 2025

Sponsor / Collaborator

Wuhan Jiulong Renfu Pharmaceutical Co., Ltd.

CTR20251220

/ Active, not recruitingNot Applicable

地屈孕酮片在中国健康人群中空腹和餐后状态下单次给药的人体生物等效性临床试验

[Translation] A human bioequivalence clinical trial of dydrogesterone tablets in Chinese healthy subjects after single administration under fasting and fed conditions

主要目的：以持证商为Abbott B.V.的地屈孕酮片（商品名：达芙通，规格：10mg）为参比制剂，以湖北民康药业集团有限公司研发的地屈孕酮片（10mg）为受试制剂，评价两种制剂在中国健康受试者中空腹和餐后状态下的生物等效性。次要目的：观察受试制剂和参比制剂在中国健康受试者中的安全性。

[Translation]

Primary objective: To evaluate the bioequivalence of the two preparations in Chinese healthy subjects in the fasting and postprandial states, using the dydrogesterone tablets (trade name: Duphaston, specification: 10 mg) of Abbott B.V. as the reference preparation and the dydrogesterone tablets (10 mg) developed by Hubei Minkang Pharmaceutical Group Co., Ltd. as the test preparation. Secondary objective: To observe the safety of the test preparation and the reference preparation in Chinese healthy subjects.

Start Date08 May 2025

Sponsor / Collaborator

Hubei Minkang Pharmaceutical Group Co., Ltd.

PACTR202504881516590

/ SuspendedNot ApplicableIIT

Comparative Evaluation of the Efficacy, Safety and Tolerability of Oral Dydrogesterone and Micronised Vaginal Progesterone in Luteal Phase Support During Assisted Reproductive Treatment in Enugu South Eastern Nigeria.

Start Date14 Apr 2025

Sponsor / Collaborator-

100 Clinical Results associated with Dydrogesterone

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100 Translational Medicine associated with Dydrogesterone

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100 Patents (Medical) associated with Dydrogesterone

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1,289

Literatures (Medical) associated with Dydrogesterone

01 Aug 2025·European Journal of Obstetrics & Gynecology and Reproductive Biology

Pharmacological Treatments for Menopausal Vasomotor Symptoms: A Systematic Review and Bayesian Network Meta-Analysis of Efficacy and Safety

Review

Author: Saraiva, Cainã Araújo ; Oliveira Amador, Wellgner Fernandes ; Queiroz, Ivo ; Pinilla Alarcón, Juan Alejandro ; Roberto De Sa, Joao ; Iqbal, Asad ; de Souza Gaio, Giovana ; Ruelas, Mariano Gallo

OBJECTIVES:

To evaluate the efficacy and safety of pharmacological treatments for vasomotor symptoms (VMS) in postmenopausal women.

METHODS:

A systematic search was conducted in PubMed, Embase, and the Cochrane Library through January 2025. Eligible studies were Phase 3 or 4 randomized controlled trials (RCTs) assessing pharmacological treatments for moderate to severe VMS with ≥ 12 weeks of follow-up. A Bayesian random-effects network meta-analysis estimated mean differences (MDs) and risk ratios (RRs) with 95 % credible intervals (CrI). Treatments were ranked using surface under the cumulative ranking (SUCRA). Risk of bias was assessed using Cochrane's tool.

RESULTS:

Forty-one RCTs (n = 14,743; mean age 53.4 years) were included. Synthetic conjugated estrogens (SCE) 1.25 mg showed the greatest reduction in VMS frequency (MD -5.69; 95 % CrI -7.93 to -3.38), while drospirenone 0.5 mg + estradiol 0.5 mg was most effective for severity (MD -1.06; 95 % CrI -1.39 to -0.72). Most treatments had safety profiles similar to placebo, though estradiol 0.5 mg + dydrogesterone 2.5 mg was linked to more adverse events (RR 1.56; 95 % CrI 1.16 to 2.24). No significant differences in serious adverse events were found. SUCRA rankings highlighted SCE and transdermal estradiol gel as most effective for frequency, while drospirenone + estradiol led for severity. Fezolinetant and elinzanetant showed moderate efficacy. Of the studies, 22 had low risk of bias, and 19 had some concerns.

CONCLUSIONS:

Conjugated estrogens and drospirenone with estradiol are the most effective options for reducing VMS frequency and severity, and Fezolinetant and Elinzanetant showed moderate efficacy, with overall similar safety across treatments.

01 Jul 2025·MARINE POLLUTION BULLETIN

Spatiotemporal distribution and priority assessment of steroids in the estuarine environment: Implications for environmental risk management

Article

Author: Hong, Bing ; Yu, Shen ; Xu, Ru ; Hu, Yong-Xia ; Liu, Shan ; Xu, Xiang-Rong ; Hao, Qin-Wei ; Chen, Hui ; Wu, Nian-Nian

Steroids, known for their endocrine-disrupting capabilities, have become a subject of considerable concern in the scientific community. This research offers a thorough evaluation of steroid contaminants within the Jiulong River Estuary (JRE), examining their spatiotemporal distribution, multimedia distribution, and mass inventory. Seven steroids were detected in water samples, while ten steroids were identified in sediments, with concentrations ranging from 0.2 to 51 ng/L in water and no-detectable (ND) to 12 ng g^-1 in sediments. In both water and sediments, natural steroids were the most prevalent throughout both the dry and wet seasons. The distribution of these compounds within the aquatic-sediment system was governed by their hydrophobicity and a suite of environmental factors, such as temperature, salinity, pH, chlorophyll-a, and total organic carbon content. Mass inventory analysis revealed that over 90 % of the total steroid mass inventory was stored in the sediments, underscoring their pivotal role as a repository for these substances within the JRE. Furthermore, this research represents the first comprehensive screening to identify priority contaminants in this region. Utilizing a multi-metric evaluation approach, progesterone and testosterone were identified as high-priority pollutants during the dry season, with progesterone alone ranking as a high-priority pollutant in the wet season. This study provides crucial insights for the management of steroid-related pollution and the assessment of environmental risks in estuarine ecosystems.

01 Jul 2025·JOURNAL OF HAZARDOUS MATERIALS

Screening and risk assessment of priority organic micropollutants for control in reclaimed water in China

Article

Author: Wang, Zijian ; Meng, Qingling ; Wen, Zhao ; Sun, Kaicheng ; Xue, Honghai

Organic micropollutants (OMPs) in reclaimed water have been frequently detected over the past decades, posing significant risks to ecosystems and human health. Given the complexity of these pollutants and the differences in their risk and toxicity, current assessments remain incomplete. This study conducted a large-scale investigation of OMPs in reclaimed water across China and developed a comprehensive multi-criteria integrated scoring method based on OMP toxicity and exposure potential. This method aims to protect aquatic organisms and human health by screening and prioritizing OMPs in reclaimed water, classifying their priority levels, and creating a prioritized control list. The study quantified OMP exposure potential, environmental persistence, bioaccumulation, and impacts on ecology and human health. The survey detected 369 OMPs from 11 chemical classes, with 325 compounds passing pre-selection. According to the prioritization scheme, 29 OMPs were identified as high priority, 171 as medium priority, and 125 as low priority. The BPs and Other Industrial Chemicals categories had the highest average maximum concentrations, followed by HPCCs and PAEs. High-priority pollutants were dominated by PAHs and PCBs, each comprising 31.03 %. Medium- and low-priority groups were mainly composed of Pesticides. PAHs and PCBs showed higher risk quotients, indicating significant ecological risks, while PCB 126, BaP, and PFOA exhibited high toxicity and potential health risks. This study provides valuable information for controlling priority pollutants in Chinese reclaimed water and establishes a foundation for OMP risk management. Future research should intensify monitoring to ensure the safe and sustainable use of water resources.

14

News (Medical) associated with Dydrogesterone

29 Nov 2024

·pharma.economictimes.indiatimes.com

CORONA’s manufacturing plant for hormonal products completed, production to begin by 2026

Ahmedabad: The construction of CORONA Remedies Private Limited, state-of-the-art hormonal product manufacturing plant in Bhayla, Ahmedabad has been completed and the company is expecting commercial production from the unit to commence in FY 2026. With an annual production capacity of 20 crore units, the plant is designed to meet growing domestic and international demand. It will focus on producing a range of female hormone products , including treatments for conditions such as dysmenorrhoea, polycystic ovary syndrome ( PCOS ), infertility, PMS & hormonal disorders . The facility is equipped with isolator systems for handling potent hormonal APIs , ensuring zero contamination, maximum safety and meets the highest regulatory standards. Nirav Mehta, Managing Director & CEO of CORONA Remedies said, “India’s women’s healthcare sector is growing rapidly, driven by increasing awareness and prevalence of conditions like PCOS infertility, PMS & hormonal disorders. With cutting-edge technology and adherence to global standards, we are poised to meet both local and global demand.” As per the release, “The company currently occupies four per cent market share in the female hormone category and leads in categories like progesterone, dydrogesterone, and norethisterone.” By Online Bureau ,

28 Nov 2024

·www.pharmaindustrial-india.com

CORONA Remedies to Launch its New Hormonal Products Manufacturing Plant in Ahmedabad

CORONA Remedies has announced about its upcoming state-of-the-art hormonal product manufacturing plant in Bhayla, Ahmedabad. The construction of the facility has been completed. Commercial production is expected to commence in FY 2026, marking a significant step forward in CORONA’s commitment to women’s healthcare. The new facility will focus on producing a range of essential female hormone products, including treatments for conditions such as dysmenorrhoea, polycystic ovary syndrome (PCOS), infertility, PMS & hormonal disorders. With an annual production capacity of 20 crore units, the plant is designed to meet growing domestic and international demand. CORONA Remedies already holds a strong position in the women’s health segment, with a 4 percent market share in the female hormone category. The company ranks among the top 10 players in the Indian market, with leadership in key products such as progesterone, dydrogesterone, and norethisterone. The company’s existing manufacturing infrastructure, certified by WHO-GMP and EU-GMP, supports its extensive portfolio in areas including cardiovascular care, neuropathy, pain management and urology. Two DSIR-approved R&D centres, staffed by over 100 scientists working on more than 80 projects, drive CORONA’s innovation. This new hormone facility will integrate advanced automation and AI technologies, reinforcing the company’s dedication to quality, safety, and efficacy. Nirav Mehta, Managing Director & CEO of CORONA Remedies, emphasised, “India’s women’s healthcare sector is growing rapidly, driven by increasing awareness and prevalence of conditions like PCOS infertility, PMS & hormonal disorders. Despite women comprising nearly 50 percent of the population, the country has very few specialised hormonal products’ manufacturing units. Our new facility aims to bridge this gap, ensuring high-quality, consistent hormonal products for millions of women. With cutting-edge technology and adherence to global standards, we are poised to meet both local and global demand.” The facility is equipped with advanced isolator systems for handling potent hormonal APIs, ensuring zero contamination and maximum safety. Designed to meet the highest regulatory standards, it reflects CORONA Remedies’ commitment to providing innovative and affordable healthcare solutions, reinforcing its position as a leader in India’s pharmaceutical industry.

28 Nov 2024

·www.pharmaindustrial-india.com

CORONA Remedies to Launch its New Hormonal Products Manufacturing Plant in Ahmedabad

CORONA Remedies has announced about its upcoming state-of-the-art hormonal product manufacturing plant in Bhayla, Ahmedabad. The construction of the facility has been completed. Commercial production is expected to commence in FY 2026, marking a significant step forward in CORONA’s commitment to women’s healthcare. The new facility will focus on producing a range of essential female hormone products, including treatments for conditions such as dysmenorrhoea, polycystic ovary syndrome (PCOS), infertility, PMS & hormonal disorders. With an annual production capacity of 20 crore units, the plant is designed to meet growing domestic and international demand. CORONA Remedies already holds a strong position in the women’s health segment, with a 4 percent market share in the female hormone category. The company ranks among the top 10 players in the Indian market, with leadership in key products such as progesterone, dydrogesterone, and norethisterone. The company’s existing manufacturing infrastructure, certified by WHO-GMP and EU-GMP, supports its extensive portfolio in areas including cardiovascular care, neuropathy, pain management and urology. Two DSIR-approved R&D centres, staffed by over 100 scientists working on more than 80 projects, drive CORONA’s innovation. This new hormone facility will integrate advanced automation and AI technologies, reinforcing the company’s dedication to quality, safety, and efficacy. Nirav Mehta, Managing Director & CEO of CORONA Remedies, emphasised, “India’s women’s healthcare sector is growing rapidly, driven by increasing awareness and prevalence of conditions like PCOS infertility, PMS & hormonal disorders. Despite women comprising nearly 50 percent of the population, the country has very few specialised hormonal products’ manufacturing units. Our new facility aims to bridge this gap, ensuring high-quality, consistent hormonal products for millions of women. With cutting-edge technology and adherence to global standards, we are poised to meet both local and global demand.” The facility is equipped with advanced isolator systems for handling potent hormonal APIs, ensuring zero contamination and maximum safety. Designed to meet the highest regulatory standards, it reflects CORONA Remedies’ commitment to providing innovative and affordable healthcare solutions, reinforcing its position as a leader in India’s pharmaceutical industry.

100 Deals associated with Dydrogesterone

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External Link

KEGG	Wiki	ATC	Drug Bank
D01217	Dydrogesterone	G03DB01	DB00378

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Uterine Hemorrhage	China	Abbott Healthcare Products BV	31 Dec 2002
Abortion, Habitual	Japan	Viatris Pharmaceutical GK	31 Oct 1964
Abortion, Threatened	Japan	Viatris Healthcare GK	31 Oct 1964
Amenorrhea	Japan	Viatris Pharmaceutical GK	31 Oct 1964
Dysmenorrhea	Japan	Viatris Pharmaceutical GK	31 Oct 1964
Infertility	Japan	Viatris Pharmaceutical GK	31 Oct 1964
Metrorrhagia	Japan	Viatris Pharmaceutical GK	31 Oct 1964
Endometriosis	United Kingdom	Solvay SA	01 Jan 1961
Menstruation Disturbances	United Kingdom	Solvay SA	01 Jan 1961

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Infertility, Female	Phase 3	Austria	Abbott Laboratories	01 Aug 2013
Infertility, Female	Phase 3	Belgium	Abbott Laboratories	01 Aug 2013
Infertility, Female	Phase 3	Finland	Abbott Laboratories	01 Aug 2013
Infertility, Female	Phase 3	Germany	Abbott Laboratories	01 Aug 2013
Infertility, Female	Phase 3	Israel	Abbott Laboratories	01 Aug 2013
Infertility, Female	Phase 3	Russia	Abbott Laboratories	01 Aug 2013
Infertility, Female	Phase 3	Spain	Abbott Laboratories	01 Aug 2013

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03858049 (CTgov)	Phase 4	Infertility	172	Crinone	wxjefuhfxw = kcziikdbmp jjcvzoofwq (ywnwxhvnds, mzrkfgrdyg - oqahxoubyb) View more	-	12 Mar 2024
NCT04537078 (CTgov)	Phase 3	Infertility, Female	90	Gonadotropin+Decapeptyl+Cyclo-Progynova+progesterone+Duphaston (the Progestin Primed Double Stimulation Group)	kyhguzytqz(nuqxkiqkcj) = gjyzvjsfgm dqazhktlbc (bslijcfanr, gfacgtdrqd - kvkfvmvaim) View more	-	17 Feb 2022
				Chorionic Gonadotropin+Cetrotide Injectable Product+Decapeptyl+Cyclo-Progynova+progesterone (the Flexible GnRh Antagonist)	qiosheeyer(ekglosyevn) = ifmbonslft ttwdybahbk (gyozqsacex, stpwpftpqm - drdnmptteo) View more
NCT03935152 (Pubmed \| BMC Pregnancy Childbirth)	Phase 4	Obstetric Labor, Premature	48	Oral dydrogesterone 10mg	tyzqhypbia(kmrvfljqro) = sgxtdvyjeh ugxblpkthw (gffwxnahqp )	Negative	28 Jan 2021
				Placebo	tyzqhypbia(kmrvfljqro) = xoqtuovtgn ugxblpkthw (gffwxnahqp )
NCT02491437 (Lotus II, CTgov)	Phase 3	Infertility, Female	1,034	Dydrogesterone 30 mg (Dydrogesterone Tablets 3x10 mg)	flrxpvtyjy = ccjjpakkil ioqpfofpwl (mxyraxqztg, zhaakswksb - ubkwtkiluz) View more	-	01 Oct 2019
				intravaginal progesterone gel 90 mg (Crinone 8% Intravaginal Progesterone Gel 90 mg)	flrxpvtyjy = ubylhwmvwt ioqpfofpwl (mxyraxqztg, mblmqtdzsr - prfquupxks) View more
NCT02491437 (Lotus II, Pubmed \| Hum Reprod)	Phase 3	Ventricular Fibrillation, Paroxysmal Familial, 1	1,034	Oral dydrogesterone 30 mg	npxohcqqsd(pvhupqhrxk) = uchlcjcgyt abhfwakdyv (utstpernoa ) View more	Positive	10 Oct 2018
				8% MVP gel 90 mg	npxohcqqsd(pvhupqhrxk) = yzumxewqer abhfwakdyv (utstpernoa ) View more
NCT01850030 (Lotus I, CTgov)	Phase 3	Infertility, Female	1,070	Placebo progesterone+Dydrogesterone 30 mg (Dydrogesterone 30 mg)	fqaazbzsrc = oicdhxthlz umtvmqvwkw (jbwlczzost, rojfuzsxlg - jgxcqxsykm) View more	-	02 Jan 2018
				Placebo dydrogesterone+Micronized Progesterone 600 mg (Micronized Progesterone 600 mg)	fqaazbzsrc = fesiegqhan umtvmqvwkw (jbwlczzost, afxguwzpos - bxjrvsncvf) View more
ChiCTR-IOR-15007265 (Pubmed \| Fertil Steril)	Not Applicable	Infertility	250	Duphaston	ckddevqtvz(kldvkvplsv) = frzgmjewbd fxttwdvdvf (puphphaaiq ) View more	-	01 Sep 2017
				Utrogestan	ckddevqtvz(kldvkvplsv) = ywoudgdcyw fxttwdvdvf (puphphaaiq ) View more
NCT01850030 (Lotus I, Pubmed \| Hum Reprod)	Phase 3	-	1,031	Oral dydrogesterone 30 mg daily	vdhfwvjwei(asqmqjngtn) = gxinfvknzn nengottrwj (tmmszizywb ) View more	Positive	01 May 2017
				Micronized vaginal progesterone 600 mg daily	vdhfwvjwei(asqmqjngtn) = pkzgzedyql nengottrwj (tmmszizywb ) View more
NCT03935152 (Pubmed \| Sci Rep)	Phase 4	Obstetric Labor, Premature Adjuvant	48	Oral dydrogesterone (20mg daily)	tshkrtsztm(usadyewwjv) = zzsyaorcex biiiqftpsq (vxjzddwouy ) View more	Negative	09 Feb 2016
				Oral placebo	tshkrtsztm(usadyewwjv) = oxzcazfieb biiiqftpsq (vxjzddwouy ) View more
NCT01178931 (Pubmed \| Eur J Obstet Gynecol Reprod Biol)	Not Applicable	-	853	Crinone 8% vaginal progesterone gel	noesuncnzz(yyhvdariks) = Interference with coitus occurred significantly more in Crinone group than in dydrogesterone group jncqmvlkon (svsxquvfoo ) View more	-	01 Mar 2015
				Oral dydrogesterone Duphaston