AGI-001 is in
Phase II development for the treatment of Functional
Dyspepsia and Irritable Bowel Syndrome (IBS)
AGI-001 is an oral dosage form of espindolol (the
S-isomer of pindolol) which is being developed
by AGI for the treatment of functional dyspepsia,
a functional disorder of the upper GI tract, in
both men and women.
Functional dyspepsia, also referred to as non-ulcer dyspepsia or NUD, is a cluster
of chronic or recurrent upper GI symptoms, including early satiety, abdominal
distension and fullness and discomfort and pain, not associated with any known
structural abnormality.
Estimates as to the prevalence of functional dyspepsia vary, with some studies
suggesting that it affects up to 25 per cent of the US population annually and
accounts for up to 5% of all visits to primary care physicians. No prescription
therapeutic drug products have been found to have a high success rate in the
treatment of functional dyspepsia and there are as yet no therapeutic drug products
approved for its treatment in the US. AGI believes that functional dyspepsia
represents an unmet medical need and that there are significant market opportunities
for new therapeutic drug products which can treat the disorder.
AGI has developed a solid oral dosage form of AGI-001 and a Phase II clinical
trial evaluating the efficacy of AGI-001 in the treatment of functional dyspepsia
is currently ongoing.
AGI-001 is also being developed for the treatment of irritable bowel syndrome
(IBS) in both men and women. A Phase II clinical trial evaluating the efficacy
of AGI-001 in the treatment of IBS is currently ongoing.
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