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

+ [20]

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

Solvay SAAbbott Healthcare Products BVViatris 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 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 Sep 2026·Synthetic and Systems Biotechnology

P450 engineering via structure-guided rational design achieves high C21-selectivity and bioconversion in steroid biosynthesis

Article

Author: Xu, Lian-Hua ; Li, Shengying ; Gao, Qilin ; Yang, Jian ; Li, Rong ; Fan, Yikang ; Ma, Guiying ; Wang, Qiang ; Ma, Li

C21-hydroxylation is a crucial step in the synthesis of corticosteroids. For instance, C21-hydroxylase catalyzes the conversion of progesterone (PRO) into 11-deoxycorticosterone (DOC, the precursor of cortisol and aldosterone). Through structure-guided rational design combined with focused rational iterative site-directed mutagenesis (FRISM), we engineered the wild-type CYP154C5 from Nocardia farcinica to obtain the highly efficient variant M6a (F92A/V291L/L294I/Q239K/F180W/Q398M). This variant demonstrated a complete regioselectivity shift from C16α to C21 hydroxylation (98% selectivity) of PRO with high catalytic efficiency (>99% conversion). To further enhance catalytic performance, we engineered a redox fusion variant (M6a-RhFRED L3) that demonstrated the highest catalytic activity, achieving a 1.43-fold improvement compared to the M6a-RhFRED. Additionally, M6a-RhFRED L3 catalyzed the C21-hydroxylation of three steroid analogs (dydrogesterone, 16-dehydroprogesterone, and pregna-4,6-diene-3,20-dione), with selectivity reaching 98% and conversion rates exceeding 60%. Molecular docking and molecular dynamics (MD) simulations revealed that the PRO substrate undergoes conformational rearrangement in the M6a active site. This structural reorganization underscores the critical role of key residues in modulating regioselectivity, particularly the shift from C16α to C21 hydroxylation. This study not only provides an efficient biocatalyst for steroids C21-hydroxylation but also offers valuable insight for the rational engineering of the P450 enzymes.

01 Aug 2026·MATURITAS

Evaluation of breast risk at menopause: what impact on the use of menopausal hormone therapy?

Review

Author: Gompel, Anne ; Rodrigues, Márcio Alexandre Hipólito

A key concern with menopausal hormone therapy is the potential duration-dependent increase in breast cancer risk. Despite using progestogens (micronized progesterone and dydrogesterone), associated with the lowest risk, a slight increase in risk is still observed over 6 years of treatment. This increase in breast cancer concerns estradiol receptor-positive breast cancers and is consistent with a promoter effect on preexisting lesions. It is thus recommended to select patients according to their level of breast cancer risk before indicating menopause hormone therapy or preferring nonhormonal alternatives. A very high risk is being a carrier of a pathogenic variant or having a strong history of breast cancer in the family that occurs at a young age. Women biopsied with atypical hyperplasia, having benefited from thoracic radiotherapy at a young age, or with high breast density, are also at high risk of breast cancer. Lower-risk factors include reproductive and lifestyle factors. Some scores can, albeit imperfectly, help evaluate a woman's risk category and the probability of carrying a pathogenic variant. The IBIS score, Gail score, and CANrisk are the most commonly used tools for risk stratification. Various scientific societies have based their recommendations on the limitations of menopausal hormone therapy, depending on risk category. Discussions with the patient and lifestyle improvements can help modulate and tailor these recommendations.

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	jgjfzsvxvx = ceiqvxghrk pszubdunxw (vgcunuzrkd, sxzripknai - cemurwewwx) View more	-	12 Mar 2024
NCT04537078 (CTgov)	Phase 3	Infertility, Female	90	Gonadotropin+Decapeptyl+Cyclo-Progynova+progesterone+Duphaston (the Progestin Primed Double Stimulation Group)	jxrlnxyjbe(wwpsucyxjs) = zjsccncorp oessmkwcfr (qvihatzfcq, lqrokqqfgr - apzagqtgzd) View more	-	17 Feb 2022
				Chorionic Gonadotropin+Cetrotide Injectable Product+Decapeptyl+Cyclo-Progynova+progesterone (the Flexible GnRh Antagonist)	fvptgkqtvj(wkzfexgtnq) = rbindqxyia yvmclugoys (svdcylfhww, aloyscykgc - hcovihdijm) View more
NCT03935152 (Pubmed \| BMC Pregnancy Childbirth)	Phase 4	Obstetric Labor, Premature	48	Oral dydrogesterone 10mg	wouimznavv(fcztpgmzon) = lhyrjsdiid kwrhuuhuwe (mifntroopw )	Negative	28 Jan 2021
				Placebo	wouimznavv(fcztpgmzon) = ribpyegtrx kwrhuuhuwe (mifntroopw )
NCT02491437 (Lotus II, CTgov)	Phase 3	Infertility, Female	1,034	Dydrogesterone 30 mg (Dydrogesterone Tablets 3x10 mg)	upvktnvqlx = eqkrdrsqov pivuxubezg (pgadrfmozb, bzuslftnyt - hrnalvmwbn) View more	-	01 Oct 2019
				intravaginal progesterone gel 90 mg (Crinone 8% Intravaginal Progesterone Gel 90 mg)	upvktnvqlx = wnccagksuk pivuxubezg (pgadrfmozb, lqssqtiwlo - ttbccdqizr) View more
NCT02491437 (Lotus II, Pubmed \| Hum Reprod)	Phase 3	Ventricular Fibrillation, Paroxysmal Familial, 1	1,034	Oral dydrogesterone 30 mg	nesqqavfst(oisfamronh) = lwpwmduhcy qrvbkhbubz (hlkxfadekl ) View more	Positive	10 Oct 2018
				8% MVP gel 90 mg	nesqqavfst(oisfamronh) = nteksgmkvm qrvbkhbubz (hlkxfadekl ) View more
NCT01850030 (Lotus I, CTgov)	Phase 3	Infertility, Female	1,070	Placebo progesterone+Dydrogesterone 30 mg (Dydrogesterone 30 mg)	kngbynsmvk = onvdwwdntq pbavytqisc (apeomfibup, opqjkcalmx - ybkjfqggba) View more	-	02 Jan 2018
				Placebo dydrogesterone+Micronized Progesterone 600 mg (Micronized Progesterone 600 mg)	kngbynsmvk = kellmvlydg pbavytqisc (apeomfibup, jitdflttlz - hryebpnmpa) View more
ChiCTR-IOR-15007265 (Pubmed \| Fertil Steril)	Not Applicable	Infertility	250	Duphaston	ktzduabxuz(stjgyqlpck) = bfzoszifda gschpgxwde (xsqzkujhvi ) View more	-	01 Sep 2017
				Utrogestan	ktzduabxuz(stjgyqlpck) = htfurwghrj gschpgxwde (xsqzkujhvi ) View more
NCT01850030 (Lotus I, Pubmed 1 \| Pubmed 2 \| Hum Reprod)	Phase 3	-	1,031	Oral dydrogesterone 30 mg daily	wbemwlfaci(kxgfkmvcux) = scocqeytxz zmieelkwqu (fejnkqncgp ) View more	Positive	01 May 2017
				Micronized vaginal progesterone 600 mg daily	wbemwlfaci(kxgfkmvcux) = qgtjptxfof zmieelkwqu (fejnkqncgp ) View more
NCT03935152 (Pubmed \| Sci Rep)	Phase 4	Obstetric Labor, Premature Adjuvant	48	Oral dydrogesterone (20mg daily)	yqeganrvav(jfkiggnytf) = njyfbpvwis tkhmvuwgnb (mssdcnwavw ) View more	Negative	09 Feb 2016
				Oral placebo	yqeganrvav(jfkiggnytf) = lcraivlrlg tkhmvuwgnb (mssdcnwavw ) View more
NCT01178931 (Pubmed \| Eur J Obstet Gynecol Reprod Biol)	Not Applicable	-	853	Crinone 8% vaginal progesterone gel	awoeuihhah(penwgdrzkg) = Interference with coitus occurred significantly more in Crinone group than in dydrogesterone group qrixqxbmrx (uazlyufeez ) View more	-	01 Mar 2015
				Oral dydrogesterone Duphaston