Gedeon Richter UK Brings Back Dydrogesterone-Only HRT Option
Gedeon Richter UK has announced the launch of Nalvee (10mg dydrogesterone) in the United Kingdom, marking the long-awaited return of a dydrogesterone-only formulation for hormone replacement therapy (HRT) after more than 17 years.
The oral tablet provides clinicians with a fresh progestogen option for non-hysterectomised women receiving oestrogen therapy, enhancing the tools available for personalised menopause care.
A Proven Molecule with a Long Clinical Legacy
Nalvee is a branded generic of a dydrogesterone product first introduced in 1961. While it was withdrawn from the UK market in 2008 due to a decline in HRT use, it has continued to be available in other countries, building a robust safety profile from over six decades of clinical use.
Dydrogesterone is structurally close to natural progesterone, offering high bioavailability and specificity for progesterone receptors. This high receptor affinity allows for clinical efficacy at doses 10 to 20 times lower than micronised progesterone.
Its primary role in HRT is to protect the endometrium from unopposed oestrogen, supporting a predictable bleeding pattern – a key factor in treatment adherence.
Clinical Efficacy and Tolerability
Evidence for dydrogesterone’s effectiveness is compelling. Studies show a 97% success rate in endometrial protection with the 10mg dose.
Clinical trials in postmenopausal women have confirmed its tolerability, while a meta-analysis of four studies demonstrated that dydrogesterone combined with oestradiol produced well-tolerated, predictable bleeding profiles.
What’s more, most women experienced slight cyclical bleeds of predictable duration, which has been shown to enhance satisfaction with treatment.
A Consultant in Sexual and Reproductive Health highlighted that one of the major reasons women discontinue HRT is the return of bleeding, which often prompts further investigation. They noted that dydrogesterone’s favourable endometrial safety profile and lighter, predictable bleeding patterns provide an important alternative for personalising HRT.
Strengthening a Commitment to Women’s Health
Commenting on the launch, the Managing Director of Gedeon Richter UK said that they are delighted to bring Nalvee to the UK market, providing an additional progestogen option for menopause treatment.
They also wanted it to be noted that this expansion of their HRT portfolio underscores their dedication to women’s health.
Conclusion
With its return to the UK, Nalvee reintroduces a trusted, low-dose, dydrogesterone-only option for HRT, giving clinicians and patients greater flexibility in treatment choices.
Backed by over 60 years of safety data and proven clinical performance, it offers both effective endometrial protection and improved bleeding predictability, addressing one of the most common barriers to HRT continuation.
Its launch signals not only a renewed choice for women but also Gedeon Richter UK’s continued investment in advancing menopause care.
News Credits: Gedeon Richter launches Nalvee in UK to expand HRT options for menopause
Things you may also like: