US-based Millendo Therapeutics has begun the Phase IIb clinical trial of MLE4901 to treat polycystic ovary syndrome (PCOS).

Millendo’s oral drug candidate, MLE4901, is a non-hormonal therapy and an antagonist of the Neurokinin 3 receptor (NK3R), which can be found on the (kisspeptin / neurokinin B / dynorphin) neuron that decreases Gonadotropin Releasing Hormone (GnRH) hyperpulsatility responsible for PCOS.

Related Company Profiles

View all

The double-blind, randomised, parallel-group, placebo-controlled Phase IIb trial is designed to test the efficacy of MLE4901 to treat PCOS.

It is expected to involve 220 females who will be administered with MLE4901 in three dosages against placebo for seven months.

"We believe our lead candidate, MLE4901, addresses a significant unmet medical need, offering a new therapeutic option for PCOS beyond current off-label therapies."

The trial is primarily focused on determining the effect of MLE4901 on improving menstrual regularity in women with PCOS-induced symptoms known as amenorrhea or oligomenorrhea.

The trial's secondary goal is to examine the number of menstrual periods during week 28 of a double blind treatment period.

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.

Millendo president and CEO Julia Owens said: “We believe our lead candidate, MLE4901, addresses a significant unmet medical need, offering a new therapeutic option for PCOS beyond current off-label therapies, which are limited to managing patient symptoms.

“The initiation of this Phase IIb clinical trial marks the continued advancement of MLE4901 and is an important milestone in the progression of our robust clinical portfolio of novel treatment options for endocrine diseases.”

Millendo has recently reported positive Phase IIa clinical trial results of MLE4901 in treating PCOS, thereby achieving its primary goal of baseline change in serum luteinising hormone (LH) concentrations after seven days of treatment.