Optimising Health through Physiological Hormone Replacement

Products & Pipeline

Diurnal has created its pipeline of enhanced product opportunities by evaluating three key therapeutic indications within the endocrine area where current therapies are considered sub-optimal and could be superseded with physiological hormonal replacement:

  • A) Steroid Hormone Replacement - Diurnal’s prime objective is the development of a proprietary physiological hydrocortisone delivery platform with release profiles specifically tailored to fit the treatment regimes for steroid withdrawal, inflammatory disorders (inc. rheumatoid arthritis - RA) and adrenal insufficiency.

    Highlights -

    • Over 10 million new prescriptions for oral glucocorticoids are written in the USA p.a.
    • The total market for oral glucocorticoids is estimated at £5 Billion.
    • Approximately 0.5% of the general population and 1.8% of women over 55 years take glucocorticoids and 56% to 68% of patients with RA are treated with glucocorticoids.
    • The main side-effects of current steroid therapies are suppression of the normal cortisol rhythm and excess exposure to steroids leading to Cushing’s syndrome, characterised by fat accumulation, weight gain, skin thinning and bone and muscle weakness. Over-time, left untreated, serious cardiovascular and metabolic complications may develop. The Diurnal approach specifically addresses these side-effects to provide a therapeutic that is dose-sparing with reduced suppression of endogenous steroids.
    • Adrenal insufficiency programme successfully out-licensed to Phoqus Pharmaceuticals.
    • Diurnal intends to develop its proprietary hydrocortisone drug delivery platform and complete pharmacokinetic studies in healthy volunteers to verify the steroid hormone replacement concepts by the end of 2010
  • B) Testosterone Replacement – Diurnal seeks to develop a first-in-class orally-active native testosterone product for the treatment of hypogonadism.

    Highlights -

    • Hypogonadism (testosterone deficiency) is estimated to affect 1% of young men.
    • Market size is estimated at £800M p.a. worldwide.
    • Currently there is no oral formulation of native testosterone available because testosterone is quickly removed by the liver.
    • The only currently available oral forms are either alkylated or esterified and are sub-standard therapies that present significant pharmacokinetic variability and long-term safety issues (related to  hepatic toxicity of the alkylated and esterified salts).
    • Testosterone gels, patches and creams are inconvenient for patients and testosterone injections are painful and poorly accepted.
    • Diurnal has developed drug delivery IP and plans to expedite  formulation development, pre-clinical in vivo studies and completion of a Phase 1 pharmacokinetic study in healthy volunteers by the end of 2010.
  • C) Thyroid Hormone Replacement – Diurnal intends to develop the first physiological combination therapy of T3 (triiodothyronine) and T4 (thyroxine) hormones for hypothyroidism.

    Highlights -

    • Hypothyroidism is common affecting up to 5% of people over 60 years.
    • Market size is estimated at £800 Million p.a. worldwide.
    • Despite conventional thyroxine replacement >25% of patients with hypothyroidism report significantly impaired quality of life with medical and social economic consequences.
    • Commercially available combination products of T3 and T4 do not provide physiological replacement and at best are titrated empirically (by  the physician) based on symptomatic responses.
    • Diurnal has developed and secured initial intellectual property protection for its novel treatment principles through physiological  replacement approaches for T3 and T4.
    • Diurnal has also completed an initial formulation  development programme to enable the selection of drug delivery technology to underpin its development programme.
    • Diurnal plans to complete formulation development, Phase 1  pharmacokinetic studies and a Phase 2A efficacy-based study in patients

Coming Soon


Phase 1 completed December 2009. Moving into Phase 2 mid-June 2010