Innovating for Well-being

Throughout our 130-year history, we have focused on developing medicines that effectively restore, restart and regulate fundamental female and male body processes.  From our initial tonic wine to homeopathic, orally delivered remedies for a variety of respiratory, cardiovascular, anti-inflammatory conditions to our current pipeline of hormone-replacement therapies, Besins has built an impressive track record of innovation through cutting-edge research and progressive partnership.

We developed transdermal gel technology, a novel drug-delivery mechanism, with several benefits over transdermal patches.  Besins was the first company to successfully commercialize this technology with the introduction of Progestogel® and Oestrogel®.  With the introduction of Utrogestan®, we became a world leader in bioavailable, orally administered natural progesterone treatments.  We pioneered micronized progesterone firstly as an oral formulation then extended into vaginal administration for a host of women’s health indications.  Another development included the world’s first dihydrotestosterone (DHT) treatment for andropause and gynecomastia.

Today, our discovery and development efforts are focused on gynecology, fertility, obstetrical conditions and androgen deficiency — a core set of therapeutic areas where we have proven expertise.  Besins is actively supporting more than 40 investigator-initiated trials

Investigator Initiated Trials*
ProductStudy AcronymStudy TitlePatient Size
Testosterone gelT‐TRANSPORTTransdermal Testosterone Gel for Poor Ovarian Responders. A Multicenter Double‐blind Placebo Controlled Randomized Trial400
UtrogestanIVMInfluence of a Prematuration Culture With a Phosphodiesterase‐3 Inhibitor (PDE3‐I) on Embryonic Aneuploidy Rate and Developmental Potential213
UtrogestanIVMA single centre randomized controlled trial investigating the influence of a novel prematuration system (PMS) using a phosphodiesterase‐3 inhibitor for in‐vitro maturation of oocytes“160
UtrogestanN/AOral Micronized Progesterone for Perimenopausal Vasomotor Symptoms249
UtrogestanPROTOPilot Randomized Controlled Trial of Vaginal Progesterone to Prevent Preterm Birth in Women With Threatened Preterm Labor34
UtrogestanN/AOral Micronized Progesterone Effects on Perimenopausal Menstrual Flow59
UtrogestanN/AThe Impact of Progesterone on the Risk of Preterm Birth Among Women With Second Trimester Bleeding. A Double Blind Placebo Controlled Trial268
UtrogestanN/AVaginal Progesterone for the Prolongation of Pregnancy After Arrested Pre‐term Labor ‐ Randomized Double Blind Placebo Controlled Trial120
UtrogestanPROTECTProgestagens for the Tertiary Prophylaxis of Preterm Delivery in Women With Short Cervix. A Randomized Multicentre Trial480
To evaluate therapeutic potential of hormone therapy (Estrogel + mic progesterone) co‐ administered with donepezil in Korean women with mild cognitive impairment
UtrogestanQUADRUPLE PPessary or Progesterone to Prevent Preterm birth in women with short cervical length1020
UtrogestanN/AVaginal Progesterone for Prevention of Preterm Birth After an Episode of Preterm Labor30
UtrogestanOPPTIMUMDoes progesterone prophylaxis to prevent preterm labour improve outcome – a randomised double blind placebo controlled trial750
UtrogestanPRISMEffectiveness of progesterone to prevent miscarriage in women with early pregnancy bleeding: A randomised placebo‐controlled trial4150
UtrogestanSuPPoRTThe prevention of preterm birth in women who develop a short cervix. A multicentre randomised controlled trial to compare three treatments; cervical cerclage, cervical pessary and vaginal progesterone540
UtrogestanRECAPTo prevent spontaneous preterm birth in asymptomatic high‐risk women ‐ Feasibility study (pilot): Progesterone vs Cerclage vs Arabin Pessary39
UtrogestanPROMISEFirst trimester progesterone theraspy in women with a history of unexplained recurrent miscarriages: A randomised, double‐blind, placebo‐controlled, multi‐centre trial790
UtrogestanEVENTSEarly vaginal progesterone for the preVention of spontaneous prEterm birth iN TwinS: A randomised, placebo controlled, double‐blinded trial1180
UtrogestanN/AThe Central Nervous System Effects of Pharmacologically Induced Hypogonadotropic Hypogonadism With and Without Estrogen and Progesterone Replacement150
TestogelT4ADSTestosterone for Androgen Deficiency‐Like Symptoms: A three phase, placebo‐controlled, double‐blind crossover study for males 40 years or older who believe they have androgen‐ like deficiency to assess whether testosterone gel treatment is superior to a placebo gel.40
German registry of hypogoandism in men
TestogelT&DEffects of Transdermal Testosterone and/or Monthly Vitamin D on Fall Risk in Pre‐‐frail Hypogonadal Seniors. Double Blind, 2×2 Factorial, Randomized Placebo‐‐Controlled Clinical Trial168
TestogelT‐IRAndrogen‐mediated pathways in the regulation of insulin sensitivity in men60

Besins Healthcare global research and development is conducted out of Besins healthcare Ireland , which focuses on unmet medical needs. Advancing medical science and improving clinical patient outcomes are two goals and drivers for our company, & our employees as we enter our next era of innovation.

Products in Development
Product CandidatesProof of ConceptPhase 1/2Phase 3
Indication: VMS (menopause)
PROGEST Phase 3 study
Indication: Reduction of breast density
4WARD Phase 3 study ( NCT03199963)
Indication: Prostate Cancer
MASTERS Phase 2 study (ClinicalTrials. gov: NCT02349386)
Indication: Endometrial Priming
Indication: Gynecomastia

Indication: HRT or T diagnostic
* PRNewswire, Global Market Insights
** Phase 2 Study of Afimoxifene Gel to Treat Cyclic Mastalgia in Premenopausal Women successfully completed ( : NCT00272714)