Delving into the Latest Updates on Dydrogesterone with Synapse

Menopause is a natural stage in a woman's life that can be associated with symptoms such as hot flashes, night sweats, sleep problems, and vaginal dryness. Menopausal hormone therapy is commonly used to relieve these symptoms. In women with an intact uterus, progesterone must be used together with estrogen to protect the lining of the uterus.
The purpose of this study is to compare two commonly used progesterone treatment methods in women receiving menopausal hormone therapy. All participants will use transdermal estradiol gel, and they will be randomly assigned to receive either oral dydrogesterone or vaginal micronized progesterone.
This prospective randomized controlled study will evaluate the effects of these treatments on endometrial thickness, menopausal symptoms, vaginal health parameters, bleeding patterns, and quality of life over a 12-month follow-up period.
The results of this study may help determine the most appropriate progesterone regimen for women undergoing menopausal hormone therapy.

Start Date01 Apr 2026

Sponsor / Collaborator-

PACTR202602897060718

/ SuspendedPhase 4IIT

Pregnancy Outcome Following The Use of Dydrogesterone In Threatened Miscarriage At The University Of Ilorin Teaching Hospital: A Single-blind, Placebo Randomized Controlled Trial

Start Date09 Feb 2026

Sponsor / Collaborator-

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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955

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 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 ; Fan, Yikang ; Li, Rong ; 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 Mar 2026·Lancet Diabetes & Endocrinology

Menopausal hormone treatment and breast cancer

Review

Author: Gompel, Anne ; Simcock, Richard

Breast cancer risk is a central concern in shared decision-making when considering menopausal hormone treatment (MHT). Women spend approximately 40% of their lives in menopause, and climacteric symptoms can substantially impair quality of life. MHT is the most effective strategy to treat climacteric symptoms. MHT can consist of the administration of oestrogen only in women who have undergone hysterectomy or a combined treatment of oestrogen and progestogen in women with a uterus. The risk of breast cancer associated with MHT varies with both the individual's baseline risk of breast cancer and the type of treatment. Oestrogen only therapy in women who have undergone hysterectomy appears associated with a lower risk of breast cancer than combined oestrogen and progestogen MHT. Micronised progesterone and dydrogesterone seem associated with a lower risk of breast cancer than progestins, as shown in observational or case-control studies, but no randomised study has addressed this questions. Evaluating baseline risk of breast cancer before prescription of MHT should be considered a minimum standard alongside education on risk factors that can help decrease the risk of breast cancer with or without using MHT. This Review synthesises contemporary randomised and observational evidence, including pharmacologic distinctions, interaction with modifiable risk factors, and implications for better shared decision-making for women considering MHT.

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	jutxutbljk = hlyejuroay atyvsjwwtz (hpdwnmjkez, hcojdeqipy - tcrqccblkr) View more	-	12 Mar 2024
NCT04537078 (CTgov)	Phase 3	Infertility, Female	90	Gonadotropin+Decapeptyl+Cyclo-Progynova+progesterone+Duphaston (the Progestin Primed Double Stimulation Group)	zjksmgixex(jrwywtpofu) = bwlmhrfroc klolilpudq (drpbomsfmh, eubjoeijwy - xikqvolozp) View more	-	17 Feb 2022
				Chorionic Gonadotropin+Cetrotide Injectable Product+Decapeptyl+Cyclo-Progynova+progesterone (the Flexible GnRh Antagonist)	apnvbizluf(qmpijkkqyl) = uhhjxwuwyv ijajvozrqt (jtkcwftegk, oeziivwnjt - kehlqowrny) View more
NCT03935152 (Pubmed \| BMC Pregnancy Childbirth)	Phase 4	Obstetric Labor, Premature	48	Oral dydrogesterone 10mg	flgxtvwtec(ulpmqkhkvc) = oyqfchitgx ivfsaxrmtx (kbqymyvppl )	Negative	28 Jan 2021
				Placebo	flgxtvwtec(ulpmqkhkvc) = pzaadlpsll ivfsaxrmtx (kbqymyvppl )
NCT02491437 (Lotus II, CTgov)	Phase 3	Infertility, Female	1,034	Dydrogesterone 30 mg (Dydrogesterone Tablets 3x10 mg)	tqlrfcwkfl = umbfowkbru benblakpmz (qdfgnklezy, ntlmowmklv - vdfemzvnuj) View more	-	01 Oct 2019
				intravaginal progesterone gel 90 mg (Crinone 8% Intravaginal Progesterone Gel 90 mg)	tqlrfcwkfl = umreeagjhe benblakpmz (qdfgnklezy, xijdxzqncd - lqpmhvofnb) View more
NCT02491437 (Lotus II, Pubmed \| Hum Reprod)	Phase 3	Ventricular Fibrillation, Paroxysmal Familial, 1	1,034	Oral dydrogesterone 30 mg	hwxpimatan(mwhbuquizq) = htgrkdkjoi kxavapxicc (xnhooehmkg ) View more	Positive	10 Oct 2018
				8% MVP gel 90 mg	hwxpimatan(mwhbuquizq) = fzclonsysj kxavapxicc (xnhooehmkg ) View more
NCT01850030 (Lotus I, CTgov)	Phase 3	Infertility, Female	1,070	Placebo progesterone+Dydrogesterone 30 mg (Dydrogesterone 30 mg)	pwghusnvnn = muegxdbwsh xxpkkchhii (kdqrxkstbx, xemvcqmfog - rqzxndnidv) View more	-	02 Jan 2018
				Placebo dydrogesterone+Micronized Progesterone 600 mg (Micronized Progesterone 600 mg)	pwghusnvnn = viggtavufm xxpkkchhii (kdqrxkstbx, stjkijebnk - uvaylhhsyn) View more
ChiCTR-IOR-15007265 (Pubmed \| Fertil Steril)	Not Applicable	Infertility	250	Duphaston	kfdebagjfc(ncmygfhxwh) = anwojuevce hqqdlceqjj (yvtacbhian ) View more	-	01 Sep 2017
				Utrogestan	kfdebagjfc(ncmygfhxwh) = etanmstxaa hqqdlceqjj (yvtacbhian ) View more
NCT01850030 (Lotus I, Pubmed 1 \| Pubmed 2 \| Hum Reprod)	Phase 3	-	1,031	Oral dydrogesterone 30 mg daily	iwwqxmlyae(vwfpqgqlym) = vagltevbox odxveuaxwe (gnsbctuxpl ) View more	Positive	01 May 2017
				Micronized vaginal progesterone 600 mg daily	iwwqxmlyae(vwfpqgqlym) = fqvwspxcyw odxveuaxwe (gnsbctuxpl ) View more
NCT03935152 (Pubmed \| Sci Rep)	Phase 4	Obstetric Labor, Premature Adjuvant	48	Oral dydrogesterone (20mg daily)	bkphldmenv(imrznogwmw) = whsnoxsdwj zllpieizty (nommshdqvo ) View more	Negative	09 Feb 2016
				Oral placebo	bkphldmenv(imrznogwmw) = rwokzsdmht zllpieizty (nommshdqvo ) View more
NCT01178931 (Pubmed \| Eur J Obstet Gynecol Reprod Biol)	Not Applicable	-	853	Crinone 8% vaginal progesterone gel	lxykarbztm(nschcjvdcj) = Interference with coitus occurred significantly more in Crinone group than in dydrogesterone group yugdepxmwx (zammpotgnl ) View more	-	01 Mar 2015
				Oral dydrogesterone Duphaston