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

Abbott Healthcare Products BV

Solvay SAViatris Healthcare GK

+ [1]

Inactive Organization

Abbott LaboratoriesAbbott Products LLCSolvay Pharmaceuticals SA

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

This cross-sectional study aims to compare the effectiveness of oral contraceptives, oral progesterone (didrogesterone), and inositol in regulating menstrual cycles among women diagnosed with polycystic ovary syndrome (PCOS).
PCOS is a common endocrine disorder affecting reproductive-aged women and is associated with menstrual irregularities, hyperandrogenism, and polycystic ovarian morphology. While oral contraceptives are the mainstay of treatment, their use may be contraindicated in patients with cardiovascular risk factors, liver dysfunction, or in those who desire pregnancy.
This study investigates whether oral progesterone and myo-inositol can serve as effective and safer alternatives for menstrual regulation and improvement of ovarian morphology and hyperandrogenic symptoms.
A total of 150 women aged 15-40 years with a diagnosis of PCOS will be enrolled and divided into three equal groups:
Group 1: Oral contraceptive users
Group 2: Oral progesterone users
Group 3: Inositol users The study will assess changes in menstrual regularity, ovarian morphology (via ultrasound), and clinical features such as hirsutism and acne before and after treatment.

Start Date01 Dec 2025

Sponsor / Collaborator

Ege Universitesi

CTR20252376

/ RecruitingPhase 3

瑞卢戈利片治疗子宫肌瘤相关的月经过多的有效性和安全性III期临床研究

[Translation] Phase III clinical study on the efficacy and safety of relugolix tablets in the treatment of menorrhagia associated with uterine fibroids

评价瑞卢戈利片40mg治疗子宫肌瘤相关的月经过多的有效性和安全性。

[Translation]

To evaluate the efficacy and safety of relugolix tablets 40 mg in the treatment of menorrhagia associated with uterine fibroids.

Start Date22 Sep 2025

Sponsor / Collaborator

Hangzhou Minsheng 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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946

Literatures (Medical) associated with Dydrogesterone

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

A retrospective comparison of live birth rate in freeze-all cycles between progestin-primed ovarian stimulation with dydrogesterone and GnRH antagonist protocols

Article

Author: Pham, Toan Duong ; Ho, Nguyen-Tuong ; Le, Ho Long ; Vuong, Lan Ngoc ; Le, Tien Khac ; Ho, Tuong Manh ; Le, Xuyen Thi-Ha

RESEARCH QUESTION:

Does progestin-primed ovarian stimulation (PPOS) using dydrogesterone yield a live birth rate comparable with the gonadotrophin-releasing hormone (GnRH) antagonist protocol in in-vitro fertilization (IVF) freeze-all cycles?

DESIGN:

This retrospective cohort study, conducted at a tertiary hospital from June 2022 to January 2024, included 1045 women aged 18-40 years undergoing IVF/intracytoplasmic sperm injection with freeze-all indications. Participants were assigned to receive PPOS-dydrogesterone (n = 482) or GnRH antagonist (n = 563), followed by frozen embryo transfer (FET). The primary outcome was the live birth rate after the first FET cycle.

RESULTS:

The live birth rate after the first FET cycle were comparable between the PPOS-dydrogesterone (35.1 %) and GnRH antagonist (40.3 %) groups (p = 0.092), showing no significant difference. The PPOS-dydrogesterone group experienced a longer stimulation period [mean ± standard deviation (SD) 8.4 ± 2.0 vs 8.0 ± 2.0 days; p = 0.002] and a higher gonadotrophin dosage (mean ± SD 2622.2 ± 818.8 vs 2413.4 ± 663.4 IU; p < 0.001) than the GnRH antagonist group, but produced more blastocysts (mean ± SD 6.3 ± 3.9 vs 5.6 ± 3.5; p = 0.013). Multivariate analysis showed that age [adjusted odds ratio (aOR) 0.96, 95 % confidence interval (CI) 0.93-0.99; p = 0.006] and anti-Müllerian hormone concentration (aOR 1.05, 95 % CI 1.01-1.10; p = 0.011) were key predictors of live birth, overshadowing protocol effects (aOR 1.27, 95 % CI 0.98-1.67; p = 0.076).

CONCLUSION:

The PPOS-dydrogesterone protocol has a similar live birth rate to the GnRH antagonist protocol in IVF freeze-all cycles, with added benefits in blastocyst yield despite higher stimulation demands. Patient factors, rather than protocol choice, primarily drive outcomes, positioning the PPOS-dydrogesterone protocol as an effective alternative to the GnRH antagonist protocol.

01 Oct 2025·JOURNAL OF THE FORMOSAN MEDICAL ASSOCIATION

Comment on “Fewer good-quality cleavage embryos in dydrogesterone-primed ovarian stimulation compared to GnRH antagonist protocol in POSEIDON group 4 patients”

Letter

Author: Wu, Shangqing ; Yang, Dongbao ; Liu, Bin

01 Oct 2025·JOURNAL OF THE FORMOSAN MEDICAL ASSOCIATION

Comment on “Fewer good-quality cleavage embryos in dydrogesterone-primed ovarian stimulation compared to GnRH antagonist protocol in POSEIDON group 4 patients”

Letter

Author: Xu, Sijing ; Li, Siqi

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

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03858049 (CTgov)	Phase 4	Infertility	172	Crinone	ytppvnnnvu = mbwhbpxeby ddxqaizwyq (zrocgzjgru, dyfcmewftd - djycvyuand) View more	-	12 Mar 2024
NCT04537078 (CTgov)	Phase 3	Infertility, Female	90	Gonadotropin+Decapeptyl+Cyclo-Progynova+progesterone+Duphaston (the Progestin Primed Double Stimulation Group)	glrdyevmnk(cnacjhkzbx) = ujfjppudjz lljwmywgqp (gtnxeqblsa, smehqpakor - xpfhnnyaro) View more	-	17 Feb 2022
				Chorionic Gonadotropin+Cetrotide Injectable Product+Decapeptyl+Cyclo-Progynova+progesterone (the Flexible GnRh Antagonist)	lqmafzsjpt(atltumjkqy) = bmrhhcyotg ynrkvjirkw (wbxoggfnyz, uwumdccefc - ktgvajrqee) View more
NCT03935152 (Pubmed \| BMC Pregnancy Childbirth)	Phase 4	Obstetric Labor, Premature	48	Oral dydrogesterone 10mg	nekqwsyjng(dydcnwcynt) = ccturebiro ihvsmzmxoh (bqbasjpqbg )	Negative	28 Jan 2021
				Placebo	nekqwsyjng(dydcnwcynt) = mqtezxcrti ihvsmzmxoh (bqbasjpqbg )
NCT02491437 (Lotus II, CTgov)	Phase 3	Infertility, Female	1,034	Dydrogesterone 30 mg (Dydrogesterone Tablets 3x10 mg)	ssjrlpjstb = rdxicnpbac whuobsvymw (iuyzkrxvff, xjriorwymw - ecrvdebtrw) View more	-	01 Oct 2019
				intravaginal progesterone gel 90 mg (Crinone 8% Intravaginal Progesterone Gel 90 mg)	ssjrlpjstb = fywvuscxdy whuobsvymw (iuyzkrxvff, ebkquvllar - nmrzeeqpzp) View more
NCT02491437 (Lotus II, Pubmed \| Hum Reprod)	Phase 3	Ventricular Fibrillation, Paroxysmal Familial, 1	1,034	Oral dydrogesterone 30 mg	slokiwueht(yljajyoyim) = ksagyghycc dfsgrachbx (zhvakrgvoz ) View more	Positive	10 Oct 2018
				8% MVP gel 90 mg	slokiwueht(yljajyoyim) = sbncsjobdp dfsgrachbx (zhvakrgvoz ) View more
NCT01850030 (Lotus I, CTgov)	Phase 3	Infertility, Female	1,070	Placebo progesterone+Dydrogesterone 30 mg (Dydrogesterone 30 mg)	svfynmrnxt = zzxgwllbso zrmdsufhya (kntwfttrca, vytzjzwroj - byxtlfziit) View more	-	02 Jan 2018
				Placebo dydrogesterone+Micronized Progesterone 600 mg (Micronized Progesterone 600 mg)	svfynmrnxt = rlojulzyiz zrmdsufhya (kntwfttrca, vnhsnpwxgx - pwleiqnkpc) View more
NCT01850030 (Lotus I, Pubmed \| Hum Reprod)	Phase 3	-	1,031	Oral dydrogesterone 30 mg daily	zkdrmwvulp(qzohqpqzii) = bbvedvlkyt gccsmfpasl (nxslmwybig ) View more	Positive	01 May 2017
				Micronized vaginal progesterone 600 mg daily	zkdrmwvulp(qzohqpqzii) = oqsaxlmwxe gccsmfpasl (nxslmwybig ) View more
NCT03935152 (Pubmed \| Sci Rep)	Phase 4	Obstetric Labor, Premature Adjuvant	48	Oral dydrogesterone (20mg daily)	atllsotcgu(hkxcawswxn) = pafacrhxju jktkhbpidy (djehvonpvi ) View more	Negative	09 Feb 2016
				Oral placebo	atllsotcgu(hkxcawswxn) = mxwsfdjpae jktkhbpidy (djehvonpvi ) View more
NCT01178931 (Pubmed \| Eur J Obstet Gynecol Reprod Biol)	Not Applicable	-	853	Crinone 8% vaginal progesterone gel	zuenqkcljn(ekknfiixkh) = Interference with coitus occurred significantly more in Crinone group than in dydrogesterone group ccoyxfmirh (bhdnoryjde ) View more	-	01 Mar 2015
				Oral dydrogesterone Duphaston
NCT04788108 (Pubmed \| Maturitas)	Phase 4	Abortion, Threatened	191	Dydrogesterone	gayvtrwbax(hfsfhmghkp) = qasuqnnfce dblmorkhac (ajzbyqtdlj )	Positive	01 Dec 2009
				Dydrogesterone (Conservative management)	gayvtrwbax(hfsfhmghkp) = ncddnwebmb dblmorkhac (ajzbyqtdlj )