Delving into the Latest Updates on Dydrogesterone with Synapse

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-

NCT06952296

/ Not yet recruitingNot Applicable

Study of the Effectiveness of Dydrogesterone in the Treatment of Endometriosis-related Pain

The study is an observational, multicenter, prospective, single arm study to evaluate the efficacy of dydrogesterone in endometriosis-related pain (EAP).

Start Date01 Apr 2025

Sponsor / Collaborator

Abbott Laboratories

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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1,272

Literatures (Medical) associated with Dydrogesterone

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.

01 Jul 2025·JOURNAL OF CLINICAL NEUROSCIENCE

Disproportionality analysis of progestogens and estrogens demonstrates increased meningioma risk

Article

Author: Frey, Connor ; Etminan, Mahyar

OBJECTIVE:

This study aims to clarify the relationship between the use of various progestogens and estrogens and the risk of developing meningiomas, given the widespread prescription of hormonal contraceptives and their potential implications in tumour proliferation.

METHODS:

Data from the FDA Adverse Event Reporting System (FAERS) was analyzed using disproportionality analysis to assess the association between specific progestogens and estrogens and meningioma risk. Reporting odds ratios (RORs) and 95% confidence intervals (CIs) were calculated to quantify these associations.

RESULTS:

Among progestogens, promegestone showed the highest risk with an ROR of 2620.651 (95% CI: 982.032, 6993.474), followed by medrogestone with an ROR of 871.475 (95% CI: 256.382, 2962.253) and dydrogesterone with moderate risk (ROR 113.802; 95% CI: 60.676, 213.444). For estrogens, estradiol exhibited the highest risk (ROR 17.786; 95% CI: 14.875, 21.266), followed by ethinyl estradiol (ROR 7.441; 95% CI: 6.099, 9.080), while conjugated estrogens showed a lower risk (ROR 1.736; 95% CI: 1.043, 2.889). No cases were reported for estriol, estrone, or mestranol, indicating a potentially lower risk profile for these estrogens.

CONCLUSION:

The study reveals significant variations in meningioma risk associated with different hormonal therapies. Certain progestogens and estrogens present notably higher risks, emphasizing the need for personalized risk assessments in hormonal therapy prescriptions. These findings advocate for further research to better understand meningioma risk linked to hormone-based contraceptives, supporting safer clinical decision-making.

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	shzhmqslcl = xnbtvwrewc wxfbfmrcks (tsbzigmxnj, fdzxxmothd - ssglufheli) View more	-	12 Mar 2024
NCT04537078 (CTgov)	Phase 3	Infertility, Female	90	Combined Oral Contraceptive+Decapeptyl+Cyclo-Progynova+progesterone+Gonadotropin+Duphaston (the Progestin Primed Double Stimulation Group)	haehypjdlc(dkbmigujrq) = equpvunqru yzwpdkyxzp (qhjcubstbw, eiakewswwg - rlqwfcjskq) View more	-	17 Feb 2022
				Combined Oral Contraceptive+Cetrotide Injectable Product+Decapeptyl+Cyclo-Progynova+progesterone+Chorionic Gonadotropin+Gonadotropin (the Flexible GnRh Antagonist)	vhdzbcvqhb(hzssbhkogb) = xgfsjllqvt jfuntkccpy (lcabwxrarh, ekbzgioull - krldnmnblm) View more
NCT03935152 (Pubmed \| BMC Pregnancy Childbirth)	Phase 4	Obstetric Labor, Premature	48	Oral dydrogesterone 10mg	uircijnehn(arjguffjih) = nxnbjuinad bioegywfkv (jabgxfofzt )	Negative	28 Jan 2021
				Placebo	uircijnehn(arjguffjih) = tbhfsuhhlx bioegywfkv (jabgxfofzt )
NCT02491437 (Lotus II, CTgov)	Phase 3	Infertility, Female	1,034	Dydrogesterone 30 mg (Dydrogesterone Tablets 3x10 mg)	wphujieqof = lxlygeglpe ltuoeevuha (cvarsymuod, tnnlcywtli - lfymtueuex) View more	-	01 Oct 2019
				intravaginal progesterone gel 90 mg (Crinone 8% Intravaginal Progesterone Gel 90 mg)	wphujieqof = qekeejhvsi ltuoeevuha (cvarsymuod, gwxsakeexh - svctwipqug) View more
NCT02491437 (Lotus II, Pubmed \| Hum Reprod)	Phase 3	Ventricular Fibrillation, Paroxysmal Familial, 1	1,034	Oral dydrogesterone 30 mg	cdyiqgmtmq(hybuqxlacf) = llwxakroks nfhfwrjovp (soecflcfzx ) View more	Positive	10 Oct 2018
				8% MVP gel 90 mg	cdyiqgmtmq(hybuqxlacf) = khkbkvluvy nfhfwrjovp (soecflcfzx ) View more
NCT01850030 (Lotus I, CTgov)	Phase 3	Infertility, Female	1,070	Placebo progesterone+Dydrogesterone 30 mg (Dydrogesterone 30 mg)	euyopnmzvd = avwvjghlbx ccjphcijeu (awdvlyspdh, uqkoofxmtu - tqojeuphtt) View more	-	02 Jan 2018
				Placebo dydrogesterone+Micronized Progesterone 600 mg (Micronized Progesterone 600 mg)	euyopnmzvd = ckypcichzb ccjphcijeu (awdvlyspdh, smrstumero - ubufxsswxf) View more
ChiCTR-IOR-15007265 (Pubmed \| Fertil Steril)	Not Applicable	Infertility	250	Duphaston	pyctzdmhli(kmnwwqncht) = hpspmdxgft ssheuqdvjr (kkfglglhfn ) View more	-	01 Sep 2017
				Utrogestan	pyctzdmhli(kmnwwqncht) = vqlkryzpse ssheuqdvjr (kkfglglhfn ) View more
NCT01850030 (Lotus I, Pubmed \| Hum Reprod)	Phase 3	-	1,031	Oral dydrogesterone 30 mg daily	hwqnzbbywv(mqtngqdomv) = iguvcxlcxh hfpmozwclh (ngiusolpbt ) View more	Positive	01 May 2017
				Micronized vaginal progesterone 600 mg daily	hwqnzbbywv(mqtngqdomv) = azrzzxcguy hfpmozwclh (ngiusolpbt ) View more
NCT03935152 (Pubmed \| Sci Rep)	Phase 4	Obstetric Labor, Premature Adjuvant	48	Oral dydrogesterone (20mg daily)	nbbtlnrxvb(rsqnqmxqww) = nqfgqcazye aedcwraotw (snxazzulwp ) View more	Negative	09 Feb 2016
				Oral placebo	nbbtlnrxvb(rsqnqmxqww) = mqowrhotbx aedcwraotw (snxazzulwp ) View more
NCT01178931 (Pubmed \| Eur J Obstet Gynecol Reprod Biol)	Not Applicable	-	853	Crinone 8% vaginal progesterone gel	wdwyscovor(askkwbxtgo) = Interference with coitus occurred significantly more in Crinone group than in dydrogesterone group gljaqocvrm (rdxoyjpmyv ) View more	-	01 Mar 2015
				Oral dydrogesterone Duphaston