EnCyzix

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Questions & Answers

On 25 January 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product EnCyzix, intended for the treatment of hypogonadotropic hypogonadism in men.

The company that applied for authorisation is Renable Pharma Limited. It may request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.

What is EnCyzix?

EnCyzix is a medicine that contains the active substance enclomifene. It was to be available as capsules to be taken by mouth.

What was EnCyzix expected to be used for?

EnCyzix was expected to be used to treat hypogonadotropic hypogonadism in men. In this condition, the sex organs (the testes in men) do not work properly resulting in symptoms such as infertility, low libido, impotence, weakened bones and weight gain. EnCyzix was to be used in overweight men with a body mass index (BMI) of at least 25 kg/m2.

How does EnCyzix work?

Overweight men with hypogonadotropic hypogonadism produce too much of the hormone oestrogen. This stops the release of other hormones called gonadotrophins, which are needed for the testes to produce testosterone and to work normally. EnCyzix blocks the excess oestrogen enabling release of gonadotrophins and normal testicular function.

What did the company present to support its application?

The company presented the results of 4 main studies involving a total of 588 patients. Patients were given either EnCyzix, or placebo (a dummy treatment) with and without application of a testosterone gel. The main measures of effectiveness were the amount of sperm produced and testosterone levels.

What were the CHMP’s main concerns that led to the refusal?

The CHMP noted that although the studies showed an increase in testosterone levels with EnCyzix, they did not look at whether EnCyzix would improve symptoms such as bone strength, weight gain, impotence and libido. In addition, there is a risk of venous thromboembolism (problems due to the formation of blood clots in the veins) with the medicine. Therefore, the CHMP was of the opinion that the benefits of EnCyzix did not outweigh its risks and recommended that it be refused marketing authorisation.

What consequences does this refusal have for patients in clinical trials or compassionate use programmes?

The company informed the CHMP that there are no ongoing clinical trials or compassionate use programmes with EnCyzix.

Name Language First published Last updated
Questions and answers on refusal of the marketing authorisation for EnCyzix (enclomifene) BG = bălgarski 2018-01-26 2018-04-20
Questions and answers on refusal of the marketing authorisation for EnCyzix (enclomifene) ES = español 2018-01-26 2018-04-20
Questions and answers on refusal of the marketing authorisation for EnCyzix (enclomifene) CS = čeština 2018-01-26 2018-04-20
Questions and answers on refusal of the marketing authorisation for EnCyzix (enclomifene) DA = dansk 2018-01-26 2018-04-20
Questions and answers on refusal of the marketing authorisation for EnCyzix (enclomifene) DE = Deutsch 2018-01-26 2018-04-20
Questions and answers on refusal of the marketing authorisation for EnCyzix (enclomifene) ET = eesti keel 2018-01-26 2018-04-20
Questions and answers on refusal of the marketing authorisation for EnCyzix (enclomifene) EL = elliniká 2018-01-26 2018-04-20
Questions and answers on refusal of the marketing authorisation for EnCyzix (enclomifene) EN = English 2018-01-26 2018-04-20
Questions and answers on refusal of the marketing authorisation for EnCyzix (enclomifene) FR = français 2018-01-26 2018-04-20
Questions and answers on refusal of the marketing authorisation for EnCyzix (enclomifene) IT = italiano 2018-01-26 2018-04-20
Questions and answers on refusal of the marketing authorisation for EnCyzix (enclomifene) LV = latviešu valoda 2018-01-26 2018-04-20
Questions and answers on refusal of the marketing authorisation for EnCyzix (enclomifene) LT = lietuvių kalba 2018-01-26 2018-04-20
Questions and answers on refusal of the marketing authorisation for EnCyzix (enclomifene) HU = magyar 2018-01-26 2018-04-20
Questions and answers on refusal of the marketing authorisation for EnCyzix (enclomifene) MT = Malti 2018-01-26 2018-04-20
Questions and answers on refusal of the marketing authorisation for EnCyzix (enclomifene) NL = Nederlands 2018-01-26 2018-04-20
Questions and answers on refusal of the marketing authorisation for EnCyzix (enclomifene) PL = polski 2018-01-26 2018-04-20
Questions and answers on refusal of the marketing authorisation for EnCyzix (enclomifene) PT = português 2018-01-26 2018-04-20
Questions and answers on refusal of the marketing authorisation for EnCyzix (enclomifene) RO = română 2018-01-26 2018-04-20
Questions and answers on refusal of the marketing authorisation for EnCyzix (enclomifene) SK = slovenčina 2018-01-26 2018-04-20
Questions and answers on refusal of the marketing authorisation for EnCyzix (enclomifene) SL = slovenščina 2018-01-26 2018-04-20
Questions and answers on refusal of the marketing authorisation for EnCyzix (enclomifene) FI = suomi 2018-01-26 2018-04-20
Questions and answers on refusal of the marketing authorisation for EnCyzix (enclomifene) SV = svenska 2018-01-26 2018-04-20
Questions and answers on refusal of the marketing authorisation for EnCyzix (enclomifene) HR = Hrvatski 2018-01-26 2018-04-20

Key facts

Product details for EnCyzix
NameEnCyzix
INN or common name

enclomifene

Therapeutic area Hypogonadism
Active substance

enclomifene citrate

Date opinion adopted25/01/2018
Company name

Renable Pharma Limited

StatusNegative
Application typeInitial authorisation