Nolasiban

Active substance Nolasiban
Domain Metabolism and Endocrinology
Reason of inclusion in Horizonscan Geneesmiddelen New medicine (specialité)
Main indication Other metabolism and Endocrinology
Extended indication Improving pregnancy rate following in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) procedures.

Product

Manufacturer ObsEva
Mechanism of action Receptor antagonist
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)
Additional comments Oxytocine receptor antagonist

Registration

Registration route Centralised (EMA)
Submission date 2020
Expected Registration 2021
Orphan drug No
Registration phase Clinical trials
Additional comments Eerste resultaten van de fase 3 IMPLANT4 studie worden verwacht in december 2019.

Therapeutic value

Therapeutic value No judgement
Substantiation Primary endpoint gehaald. Absolute toename aantal zwangerschappen na 10 weken met 7,1% met nolasiban versus placebo. De verwachting is dat de impact niet groot is.
Dosage per administration 900 mg
References ObsEva persbericht 26 februari 2018; NCT03081208
Additional comments Eenmalige dosis nolasiban op 10 weken na embryo transfer.

Expected patient volume per year

References Freya.nl
Additional comments In 2016 werden er 14.584 IVF/ICSI-behandelingen uitgevoerd. Nolasiban zou bij een deel hiervan kunnen worden ingezet. Aangezien geen grote impact verwacht wordt, zal het mogelijk een klein aantal patiënten betreffen.

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension No

Other information

There is currently no futher information available.