Estetrol/drospirenone

Estetrol/drospirenone (E4/DRSP; developmental code name FSN-013) is a combination of estetrol, an estrogen, and drospirenone, a progestin, which is under development by Estetra S.A. as a combined oral contraceptive for the prevention of pregnancy in women.[1] It contains 15 mg estetrol and 3 mg drospirenone.[2] As of 2018, it is in phase III clinical trials for this indication.[1]

Estetrol/drospirenone
Combination of
Estetrol (medication)Estrogen
DrospirenoneProgestogen
Clinical data
Other namesE4/DRSP; FSN-013
AHFS/Drugs.comMonograph
Routes of
administration		By mouth
ATC code
Identifiers
ChemSpider
  • None

E4/DRSP has a much lower impact on liver protein synthesis, including of sex hormone-binding globulin, angiotensinogen, and coagulation factors, than does ethinylestradiol/drospirenone.[3]

Society and culture

On 25 March 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Lydisilka (estetrol/drospirenone), intended for oral contraception.[4] The applicant for this medicinal product is Estetra SPRL.[4] The CHMP also recommended the granting of a marketing authorisation for the medicinal product Drovelis (estetrol/drospirenone), intended for oral contraception.[5] The applicant for this medicinal product is Gedeon Richter Plc.[5]

See also

References
  1. http://adisinsight.springer.com/drugs/800034634
  2. https://investors.mithra.com/wp-content/uploads/2018/08/2018-08-08-Estelle-Phase-III-EU-RU-en.pdf
  3. Farris M, Bastianelli C, Rosato E, Brosens I, Benagiano G (October 2017). "Pharmacodynamics of combined estrogen-progestin oral contraceptives: 2. effects on hemostasis". Expert Rev Clin Pharmacol. 10 (10): 1129–1144. doi:10.1080/17512433.2017.1356718. PMID 28712325. S2CID 205931204.
  4. "Lydisilka: Pending EC decision". European Medicines Agency (EMA). 25 March 2021. Retrieved 26 March 2021. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  5. "Drovelis: Pending EC decision". European Medicines Agency (EMA). 25 March 2021. Retrieved 26 March 2021.


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