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 LaboratoriesAbbott Products LLCAbbott Laboratories GmbH

+ [1]

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

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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852

Literatures (Medical) associated with Dydrogesterone

31 Dec 2026·GYNECOLOGICAL ENDOCRINOLOGY

Dydrogesterone versus levonorgestrel-releasing intrauterine system for abnormal uterine bleeding: a propensity score-matched analysis of long-term efficacy and recurrence

Article

Author: Huang, Li ; Wei, Xiaoli ; Li, Xiangzun

OBJECTIVE:

To compare dydrogesterone versus levonorgestrel-releasing intrauterine system (LNG-IUS) for abnormal uterine bleeding (AUB) management with long-term follow-up and etiology-stratified analysis.

METHODS:

This single-center retrospective cohort study analyzed reproductive-aged women with International Federation of Gynecology and Obstetrics (FIGO)-classified AUB receiving dydrogesterone (n = 131) or LNG-IUS (n = 118). Propensity score matching balanced baseline covariates between groups (n = 104 pairs). Primary outcomes were bleeding control rates (composite: hemoglobin increase ≥ 1.5 g/dL, ≥ 50% Pictorial Blood Loss Assessment Chart [PBAC] reduction, no rescue interventions) at 3 and 12 months. Secondary outcomes included 24-month recurrence and adverse events (AEs).

RESULTS:

LNG-IUS demonstrated superior 3-month bleeding control versus dydrogesterone (82.7% vs. 65.4%; relative risk [RR] 1.26, 95% confidence interval [CI] 1.08-1.48; p = 0.002). At 12 months, bleeding control rates were comparable between groups (78.8% vs. 72.1%; RR 1.09, 95% CI 0.96-1.24; p = 0.17). LNG-IUS significantly reduced 24-month recurrence risk (hazard ratio [HR] 0.48, 95% CI 0.32-0.72; p < 0.001), particularly for structural AUB (HR 0.39, 95% CI 0.24-0.64). Subgroup analysis revealed LNG-IUS superiority in adenomyosis at 12 months (88.2% vs. 60.0%; RR 1.47, 95% CI 1.24-1.74; p < 0.001) but comparable efficacy in nonstructural AUB (76.6% vs. 72.9%; RR 0.95, 95% CI 0.78-1.16; p = 0.63). Dydrogesterone exhibited higher systemic AEs (28.2% vs. 13.6%; p = 0.003), while LNG-IUS had device-related events including expulsion (5.1%).

CONCLUSION:

LNG-IUS offers superior short-term bleeding control and sustained long-term recurrence prevention, especially for structural AUB. Dydrogesterone effectively manages nonstructural etiologies but carries higher systemic adverse event rates. Treatment selection should be etiology-guided, balancing immediate symptom control versus recurrence prevention and individualized safety considerations.

01 Feb 2026·REPRODUCTIVE BIOMEDICINE ONLINE

Network meta-analysis of progestogen administration routes for luteal phase support in fresh embryo transfer IVF cycles

Review

Author: Manipalviratn, Somjate ; Griesinger, Georg ; Kahler, Elke ; Li, Rose ; Murdia, Kshitiz ; Wang, Qian ; Pabuccu, Emre ; Labarta, Elena

The route of administration significantly influences the pharmacokinetics of progestogens. For luteal phase support (LPS) after fresh embryo transfer in IVF, ESHRE recommends vaginal, intramuscular, subcutaneous progesterone or oral dydrogesterone. This network meta-analysis evaluated the relative effectiveness of progestogen administration routes on clinical pregnancy rate (CPR) and live birth rate (LBR) in fresh IVF cycles. A systematic review identified peer-reviewed, published randomized controlled trials (RCTs) comparing individual progestogens (versus placebo or other progestogens) and reporting CPR. Studies involving frozen-thawed transfers, non-progestogenic LPS or non-available formulations were excluded. Of the 24 RCTs included, oral administration was the only route reaching statistical significance for increased CPR, although overlapping confidence intervals across comparisons indicate uncertainty in clinically relevant superiority. For LBR, only oral and intramuscular routes demonstrated statistically significant improvement versus placebo; vaginal and subcutaneous did not. These findings, supported by sensitivity analyses excluding low-quality and older studies, suggest that oral and intramuscular progestogens may be more effective in improving IVF outcomes, but outcome differences require further studies. This study substantially advances the evidence base by integrating recent data, applying rigorous quality assessment standards and using state-of-the-art network meta-analytic methodology, contributing to refining recommendations for optimal progestogenic LPS in fresh IVF cycles.

01 Jan 2026·JOURNAL OF ASSISTED REPRODUCTION AND GENETICS

Impact of Follicle Size at Trigger on Reproductive Outcomes in Letrozole-Modified Natural Frozen Embryo Transfer Cycles in High Responder Patients

Article

Author: Ucar, Ugras ; Pabuccu, Recai ; Blockeel, Christophe ; Pabuccu, Emre

PURPOSE:

To evaluate whether follicle size at hCG trigger influences reproductive outcomes in letrozole-modified natural frozen embryo transfer (let-mNC-FET) cycles among high-responder patients.

METHODS:

This observational cohort included 170 let-mNC-FET cycles. Patients were stratified by follicle-size percentiles at trigger: 0-25th (15-17 mm; n = 43), 25-75th (18-20 mm; n = 90), and > 75th (21-24 mm; n = 37). Oral dydrogesterone provided luteal support. Serum progesterone (P4) on embryo-transfer (ET) day was measured with an assay that does not detect dydrogesterone (reflecting endogenous luteal production). The primary outcome was the ongoing pregnancy rate (OPR). Group comparisons used ANOVA/Kruskal-Wallis and χ² tests; predictors of OPR were evaluated with logistic regression.

RESULTS:

Positive hCG and OPR did not differ across percentile groups (51.2%, 52.2%, 55.6%; p = 0.920 and 48.8%, 50.0%, 52.7%; p = 0.833, respectively). Endometrial thickness at trigger differed by group (medians 8.0, 9.0, 7.8 mm; p < 0.001), while ET-day P4 increased with larger follicles (medians 19.74, 21.00, 26.50 ng/mL; p = 0.001; post-hoc 0-25th vs > 75th p = 0.0009). In multivariable analysis, younger age (aOR 0.834; 95% CI 0.762-0.914; p = 0.0001), higher BMI (aOR 1.169; 1.015-1.346; p = 0.0303), fewer stimulation days (aOR 0.798; 0.647-0.983; p = 0.0343), larger leading follicle size (aOR 1.343; 1.059-1.703; p = 0.0151), and higher ET-day P4 (aOR 1.067; 1.027-1.108; p = 0.0007) independently predicted OPR; EMT and AMH were not associated (p ≥ 0.08 and p = 0.25).

CONCLUSIONS:

Although OPR did not differ across follicle-size strata, larger follicle size at trigger and higher endogenous luteal P4 were independent predictors of OPR in highresponders. Confirmation in adequately powered prospective studies is warranted.

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	cmccubrouj = yexmydeqza btcblkaueo (vnpwltsmrc, cggteuomwr - zkvpxyuddw) View more	-	12 Mar 2024
NCT04537078 (CTgov)	Phase 3	Infertility, Female	90	Gonadotropin+Decapeptyl+Cyclo-Progynova+progesterone+Duphaston (the Progestin Primed Double Stimulation Group)	ztamgaysmf(xxceygitka) = ewlnoguhns eeenwqoilv (tselynmhpq, stvhnlrnks - gxhnuvxnoe) View more	-	17 Feb 2022
				Chorionic Gonadotropin+Cetrotide Injectable Product+Decapeptyl+Cyclo-Progynova+progesterone (the Flexible GnRh Antagonist)	hyaxrhyoto(faxazphxff) = dfgeaicifv wdcajamkqz (qkmqbbrunn, mbozjsxsrs - mzcgcnhcro) View more
NCT03935152 (Pubmed \| BMC Pregnancy Childbirth)	Phase 4	Obstetric Labor, Premature	48	Oral dydrogesterone 10mg	gbkqozqnza(yjxcgvecfk) = zretbigpzj fzzcjaleaz (uzorzzkaxk )	Negative	28 Jan 2021
				Placebo	gbkqozqnza(yjxcgvecfk) = ffzgbrdotp fzzcjaleaz (uzorzzkaxk )
NCT02491437 (Lotus II, CTgov)	Phase 3	Infertility, Female	1,034	Dydrogesterone 30 mg (Dydrogesterone Tablets 3x10 mg)	ixhqhwehee = dqeonzbjyk xkrgenhwjd (iftxhumngi, csqxuiweiw - svxhecevvy) View more	-	01 Oct 2019
				intravaginal progesterone gel 90 mg (Crinone 8% Intravaginal Progesterone Gel 90 mg)	ixhqhwehee = ypstwxpxcu xkrgenhwjd (iftxhumngi, fzsnobumgb - tbhqboossr) View more
NCT02491437 (Lotus II, Pubmed \| Hum Reprod)	Phase 3	Ventricular Fibrillation, Paroxysmal Familial, 1	1,034	Oral dydrogesterone 30 mg	qdvfquopai(qbchybvgoj) = xqcdzbttdr vhtsymyxvo (jmuzkinhfe ) View more	Positive	10 Oct 2018
				8% MVP gel 90 mg	qdvfquopai(qbchybvgoj) = sudvrmaopn vhtsymyxvo (jmuzkinhfe ) View more
NCT01850030 (Lotus I, CTgov)	Phase 3	Infertility, Female	1,070	Placebo progesterone+Dydrogesterone 30 mg (Dydrogesterone 30 mg)	nvumiqstao = mvededljbr tboyceznrg (ifjeasazgi, bxovhzsrdd - csregjusmh) View more	-	02 Jan 2018
				Placebo dydrogesterone+Micronized Progesterone 600 mg (Micronized Progesterone 600 mg)	nvumiqstao = nzgggqirto tboyceznrg (ifjeasazgi, vavinpfvfy - mivqynkcrb) View more
ChiCTR-IOR-15007265 (Pubmed \| Fertil Steril)	Not Applicable	Infertility	250	Duphaston	sdtdsuohcy(kjirwdbjhj) = mtlokfyzmh dvlrnavdhi (shdbrprhdl ) View more	-	01 Sep 2017
				Utrogestan	sdtdsuohcy(kjirwdbjhj) = lyqbcmjwai dvlrnavdhi (shdbrprhdl ) View more
NCT01850030 (Lotus I, Pubmed 1 \| Pubmed 2 \| Hum Reprod)	Phase 3	-	1,031	Oral dydrogesterone 30 mg daily	dxnjzzjwih(hfhfxtpeto) = huascnegir xunpbkyigc (zzturobgyw ) View more	Positive	01 May 2017
				Micronized vaginal progesterone 600 mg daily	dxnjzzjwih(hfhfxtpeto) = tmtltbsfmm xunpbkyigc (zzturobgyw ) View more
NCT03935152 (Pubmed \| Sci Rep)	Phase 4	Obstetric Labor, Premature Adjuvant	48	Oral dydrogesterone (20mg daily)	ndoraxdvaq(hyfltxbdxh) = gpleonsntv lelyuufztz (xgcgmetxag ) View more	Negative	09 Feb 2016
				Oral placebo	ndoraxdvaq(hyfltxbdxh) = yqpzztoner lelyuufztz (xgcgmetxag ) View more
NCT01178931 (Pubmed \| Eur J Obstet Gynecol Reprod Biol)	Not Applicable	-	853	Crinone 8% vaginal progesterone gel	tvhexrrkti(uzoovqyumb) = Interference with coitus occurred significantly more in Crinone group than in dydrogesterone group psvldmvxrb (mladosvuii ) View more	-	01 Mar 2015
				Oral dydrogesterone Duphaston