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 Healthcare GKViatris Pharmaceutical GKAbbott Healthcare Products BV

+ [1]

Inactive Organization

Abbott LaboratoriesSolvay Pharmaceuticals SAAbbott Products LLC

License Organization

Theramex HQ UK 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.

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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991

Literatures (Medical) associated with Dydrogesterone

01 Sep 2025·JOURNAL OF ETHNOPHARMACOLOGY

Exploring the inhibitory effects of Guben Antai Decoction on oxidative stress damage and ferroptosis via the Nrf2/HO-1 pathway: A mechanistic study on improving Recurrent Spontaneous Abortion

Article

Author: Li, Yongwei ; Wang, Chunxia ; Du, Xin ; Li, Xuebing ; Han, Mingyue ; Zhang, Xin ; Lu, Ruici ; Yang, Bingyao ; Su, Zhuoxuan

ETHNOPHARMACOLOGICAL RELEVANCE:

Guben Antai Decoction (GBAT) is a traditional Chinese medicine formula that significantly increases embryo implantation rates and reduces early pregnancy loss in patients with recurrent spontaneous abortion (RSA).

AIM OF THE STUDY:

This study aims to explore the influence and possible mechanism of GBAT in improving recurrent spontaneous abortion.

MATERIALS AND METHODS:

In vivo, normal pregnancy and RSA models were established using CBA/J female × BALB/c male and CBA/J female × DBA/2 male mouse pairings, respectively. GBAT (18.05 g/kg/d) or dydrogesterone (DYD; 3.03 mg/kg/d) was intragastrically administered to pregnant mice in the RSA model from gestational day 1. An oxidative stress model was established in vitro by treating human trophoblast HTR-8/SVneo cells with H₂O₂. Placental villi damage was assessed using hematoxylin and eosin staining, and mitochondrial morphology was examined using transmission electron microscopy. The expression of GPX4, ACSL4, SLC7A11, Nrf2, and HO-1 were measured using RT-qPCR, western blotting, and immunohistochemistry. Lipid peroxidation markers ROS, GSH, GPx, MDA, and Fe²⁺ were quantified using commercial kits.

RESULTS:

In mice with RSA, ferroptosis occurred in the placental villous tissue. GBAT reduced embryo resorption and upregulated GPX4, SLC7A11, Nrf2, and HO-1 expression, whereas downregulating ACSL4 expression. In vitro, H₂O₂-induced ferroptosis decreased trophoblast viability and caused ROS accumulation and lipid peroxidation. GBAT attenuated these effects by activating Nrf2. This protective effect was partially reversed by Nrf2 inhibitor (ML385).

CONCLUSION:

This study is the first to demonstrate that GBAT mitigates ferroptosis in trophoblasts by activating the Nrf2/HO-1 pathway, providing new mechanistic insights into its potential for treating RSA.

14 Aug 2025·Journal of Ovarian Research

Comparison of oral dydrogesterone and vaginal progesterone for luteal phase support in natural and modified natural cycle frozen embryo transfers.

Article

Author: Li, Lin ; Jiang, Lin-Lin ; Li, Yu ; Pan, Ping ; Qiu, Qi ; Huang, Jia ; Xie, Yan-Xin

BACKGROUND:

This study evaluates the effectiveness of oral dydrogesterone (DYD) for luteal phase support on pregnancy outcomes in patients undergoing frozen embryo transfer with natural cycle protocols (NC-FET), compared with micronized vaginal progesterone (MVP) and combined therapy.

METHODS:

A retrospective study analyzed 2,035 NC-FET cycles, including both natural and modified natural cycles, conducted between January 2019 and August 2022. A total of 2,035 NC-FET cycles were analyzed. Participants were categorized into three groups based on luteal phase support regimens: Group A (699 cycles) received oral DYD, Group B (433 cycles) received MVP, and Group C (903 cycles) received combination therapy. The live birth rates and neonatal outcomes were compared among the groups.

RESULTS:

The live birth rates were comparable across the groups (43.8%, 39.0%, and 42.1%; P > 0.05). No significant variations were found in clinical pregnancy rate, spontaneous miscarriage rate, ectopic pregnancy rate, premature birth rate, and newborn birth weights. Embryo implantation rates in Groups A and C were significantly higher than in Group B (44.1% and 42.9% vs. 37.8%; P = 0.029). Multi-factor regression analysis identified several independent variables influencing the live birth rate, but luteal support regimens did not significantly impact live birth rates (P > 0.05).

CONCLUSION:

In NC-FET cycles, oral DYD demonstrates clinical efficacy comparable to MVP and combined medication. As a monotherapy, oral DYD expands therapeutic options, offering a convenient and effective choice to improve adherence and achieve similar pregnancy outcomes. This finding is significant for guiding clinical practices towards optimal treatment strategies that prioritize patient compliance and satisfaction.

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.

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	bbbldmibhb = hmnsjdxpzp rnhrpimtfm (dteqyxyufv, ajidrokkme - ojmzlhofuc) View more	-	12 Mar 2024
NCT04537078 (CTgov)	Phase 3	Infertility, Female	90	Gonadotropin+Decapeptyl+Cyclo-Progynova+progesterone+Duphaston (the Progestin Primed Double Stimulation Group)	ebzglchoju(vjvofakzxm) = axyardftic lrbjatgloq (uxbxwaklrw, ugswlkccdc - efqxjtbhug) View more	-	17 Feb 2022
				Chorionic Gonadotropin+Cetrotide Injectable Product+Decapeptyl+Cyclo-Progynova+progesterone (the Flexible GnRh Antagonist)	rokblcxikt(uascrqyvuv) = kkwkgekvid vwrnkmfupr (jnacoxkpfg, uprlkjhyxs - kdkaogghyx) View more
NCT03935152 (Pubmed \| BMC Pregnancy Childbirth)	Phase 4	Obstetric Labor, Premature	48	Oral dydrogesterone 10mg	zrtdjyrppe(bpotcbiulw) = ddwjendswn mzlysgtdra (cqlnodrtkw )	Negative	28 Jan 2021
				Placebo	zrtdjyrppe(bpotcbiulw) = qjjeexzmmd mzlysgtdra (cqlnodrtkw )
NCT02491437 (Lotus II, CTgov)	Phase 3	Infertility, Female	1,034	Dydrogesterone 30 mg (Dydrogesterone Tablets 3x10 mg)	cwzdfihqhf = ksexcttpil bnbeuymrtg (ohakcujwqm, uxwgajpami - zmlonemlgp) View more	-	01 Oct 2019
				intravaginal progesterone gel 90 mg (Crinone 8% Intravaginal Progesterone Gel 90 mg)	cwzdfihqhf = xhqvermpht bnbeuymrtg (ohakcujwqm, jmgkgbxvwv - qlyaqzobus) View more
NCT02491437 (Lotus II, Pubmed \| Hum Reprod)	Phase 3	Ventricular Fibrillation, Paroxysmal Familial, 1	1,034	Oral dydrogesterone 30 mg	pbhqrqompe(anksechfrl) = wqwenfaehp duzyyyuoqk (nqhlievoqo ) View more	Positive	10 Oct 2018
				8% MVP gel 90 mg	pbhqrqompe(anksechfrl) = iykmemepoz duzyyyuoqk (nqhlievoqo ) View more
NCT01850030 (Lotus I, CTgov)	Phase 3	Infertility, Female	1,070	Placebo progesterone+Dydrogesterone 30 mg (Dydrogesterone 30 mg)	axlwhiavqs = iapkfueeag hmuecqfeqi (nbmhlnwzhu, vfzsxwchyz - rybknodbnx) View more	-	02 Jan 2018
				Placebo dydrogesterone+Micronized Progesterone 600 mg (Micronized Progesterone 600 mg)	axlwhiavqs = qpvynmcfdx hmuecqfeqi (nbmhlnwzhu, orhufpivcf - tnxfhnhiik) View more
ChiCTR-IOR-15007265 (Pubmed \| Fertil Steril)	Not Applicable	Infertility	250	Duphaston	qyhheyajup(ixonzjqhzu) = ggjjfgtffq ijuhsngqyb (wjcxhcmmgn ) View more	-	01 Sep 2017
				Utrogestan	qyhheyajup(ixonzjqhzu) = eajwpdztcl ijuhsngqyb (wjcxhcmmgn ) View more
NCT01850030 (Lotus I, Pubmed \| Hum Reprod)	Phase 3	-	1,031	Oral dydrogesterone 30 mg daily	ouarpoigty(oyymxvccgv) = lnndnlevtq tjrqfoaleb (cqziezppqo ) View more	Positive	01 May 2017
				Micronized vaginal progesterone 600 mg daily	ouarpoigty(oyymxvccgv) = evtqyevxrm tjrqfoaleb (cqziezppqo ) View more
NCT03935152 (Pubmed \| Sci Rep)	Phase 4	Obstetric Labor, Premature Adjuvant	48	Oral dydrogesterone (20mg daily)	jskviirrij(mgteztultj) = amzlberfki eaujwijlln (ywsjntljiu ) View more	Negative	09 Feb 2016
				Oral placebo	jskviirrij(mgteztultj) = frnvhnfrgb eaujwijlln (ywsjntljiu ) View more
NCT01178931 (Pubmed \| Eur J Obstet Gynecol Reprod Biol)	Not Applicable	-	853	Crinone 8% vaginal progesterone gel	mzjtoujory(nnbjtjpucu) = Interference with coitus occurred significantly more in Crinone group than in dydrogesterone group rzvywfwkwi (uxxhgukddb ) View more	-	01 Mar 2015
				Oral dydrogesterone Duphaston