Bayer has started a Phase III ASTEROID clinical programme of vilaprisan with enrolment of the first patient for treatment of uterine fibroids. 

Vilaprisan is Bayer’s oral, selective progesterone receptor modulator (SPRM) being developed to provide long-term treatment of uterine fibroids and endometriosis.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The ASTEROID Phase III programme is designed to evaluate the efficacy and safety of 2mg vilaprisan in multiple clinical trials involving symptomatic uterine fibroid patients.

Estimated to be performed over a period of three years, the programme will recruit more than 3,600 subjects at up to 900 sites in around 40 countries. 

"It is our ambitious goal that our research efforts in this field result in a medical therapy that controls symptoms and thereby significantly improves the quality of life for women with uterine fibroids."

Bayer Development head and Pharmaceutical division executive committee member Dr Joerg Moeller said: "Based on the promising results we have seen with vilaprisan in the Phase II clinical study programme, we are very excited about the start of the Phase III trials that aims for a new symptom control for symptomatic uterine fibroids in a long-term treatment option.

See Also:

“It is our ambitious goal that our research efforts in this field result in a medical therapy that controls symptoms and thereby significantly improves the quality of life for women with uterine fibroids.”

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The ASTEROID Phase II clinical study programme conducted in patients suffering from symptomatic uterine fibroids had been the base for the determination of dosing regimen and design of Phase III programme.

The Phase II programme included a Phase IIb ASTEROID 1 trial that compared the efficacy and safety of four doses of vilaprisan to placebo and another Phase IIb ASTEROID 2 trial that assessed the efficacy and safety of vilaprisan as compared to placebo and ulipristal acetate (Esmya).