Our products

PregLem’s product pipeline focuses on women’s reproductive medicine with significant unmet medical needs that severely impact a patient’s quality of life and fertility.

ESMYA® (Ulipristal Acetate 5mg)

ESMYA® (ulipristal acetate 5mg)

ESMYA® (ulipristal acetate 5mg), is a first-in-class, oral selective progesterone receptor modulator (SPRM) which reversibly blocks the progesterone receptor in its target tissues (uterus, cervix, ovaries, hypothalamus) and acts as a potent, orally active antiprogestational agent. It is the first medical treatment for long term management of uterine fibroids. ESMYA® has successfully completed four Phase III clinical trials in Europe and has confirmed its efficacy and safety for the long term management of uterine fibroids and the treatment of symptomatic uterine fibroids in patients prior to surgery. Pivotal clinical studies have been published in peer reviewed journals such as New England Journal of Medicine and Fertility and Sterility.

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BEMFOLA® (Follitropin Alfa)

BEMFOLA® (Follitropin Alfa)

BEMFOLA® is a recombinant-human Follicle Stimulating Hormone (r-hFSH) and was the first biosimilar r-hFSH launched in Europe. Both BEMFOLA® and the reference product are formulations of the naturally occurring hormone FSH, which plays a key role in human reproduction.
The European marketing authorisation for BEMFOLA® was supported by data from a large Phase III study, in which BEMFOLA® therapy was found to be similar to the reference product, based on the numbers of oocytes retrieved after completing FSH therapy. In this Phase III study, similar efficacy and safety profiles were observed between the two study arms and similar numbers of live babies were born to patients who became pregnant following completion of therapy.
BEMFOLA® is supplied in a single-use, unique, state-of-the-art delivery system which results in a simple, once-a-day disposable device, allowing the patient to self-inject.

PGL2001 (Steroid Sulfatase Inhibitor, STS-I)

PGL2001 is an oral, once-a-week steroid sulfatase inhibitor (STS-I) being developed for the management of endometriosis, including the relief of pain associated with the condition. Steroid sulfatases (STS) are enzymes expressed in tissues whose growth is oestrogen dependent. In these tissues, STS converts inactive oestrogens and androgens into their corresponding biologically active forms.

PGL2001 has the potential to be the first of a new class of products for the treatment of mild to moderate endometriosis and other benign gynaecological conditions.

Development stage: Phase IIa

PGL1001 (Somatostatin Antagonist, SST-ATG)

PGL1001 is a somatostatin antagonist (SST-ATG) with the potential to accelerate the recruitment of resting follicles from the ovarian follicular reserve. In this way, more follicles could be made responsive to gonadotrophin stimulation and could eventually produce an oocyte (egg). PGL1001 has the potential to become the first treatment for increasing the number of gonadotrophin-sensitive follicles in patients with a diminished or aging ovarian reserve, who undergo Assisted Reproductive Techniques (“ART”).

Development stage: Pre-Clinical Development

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