Linzagolix – Uterine Fibroids

Posted on by Sylwia Scheel-Krüger

Milestones

EC & UK MHRA Marketing Authorization for Yselty® (linzagolix) in Q2:22

CHMP confirmation of positive opinion (Q2:22)

NDA PDUFA action Q3:22

Clinical Trials

Recruitment Completed

Commercial Rights

ObsEva holds U.S. and Canadian rights

Kissei holds Asian rights

Exclusive worldwide rights outside of the U.S., Canada, and Asia licensed to Theramex

Condition

Uterine fibroids

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Disclaimer

Note that the following information contains information on investigational medicinal products. These products have not yet been approved for marketing by the European Medicines Agency or the U.S. Food and Drug Administration and are still under development. Further additional investigations may be needed in order for the marketing authorization to be granted, which grant may depend on a variety of factors and is not guaranteed. Click on “return” if you do not wish to receive such information. By clicking on “continue” you acknowledge that you wish to receive scientific information on our investigational products.

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Disclaimer

Note that the following information contains information on investigational medicinal products. These products have not yet been approved for marketing by the European Medicines Agency or the U.S. Food and Drug Administration and are still under development. Further additional investigations may be needed in order for the marketing authorization to be granted, which grant may depend on a variety of factors and is not guaranteed. Click on “return” if you do not wish to receive such information. By clicking on “continue” you acknowledge that you wish to receive scientific information on our investigational products.

Continue