Fesoterodine

Fesoterodine is a medicine already authorised for the treatment of overactive bladder in adults with symptoms of urge urinary incontinence, urgency, and frequency, and for neurogenic detrusor overactivity in children aged 6 years and older who weigh more than 25 kg.^[3] It is now also being investigated in two phase 2 clinical trials as part of a fixed combination called ML-007C-MA for hallucinations and delusions associated with Alzheimer's disease psychosis.^[2][1]

Table of contents

• What is fesoterodine?
• How does fesoterodine work?
• Which conditions is it used or studied for?
• How is fesoterodine given?
• What do the clinical trials show?
• What side effects are known?

What is fesoterodine?

Fesoterodine is a medicine that belongs to a group of drugs used for urinary problems. In the product records of the two Alzheimer's disease psychosis trials, it appears under the full registry name fesoterodine, 5-[(1R,5R)-3-azabicyclo[3.1.0]hexan-1-yl]-3-methyl-1,2,4-oxadiazole.^[2][1] The therapeutic area recorded for these trials is psychiatry and psychology, specifically mental disorders.^[2]

Fesoterodine is already marketed as fesoterodine fumarate extended-release tablets for oral use, with an initial approval in the United States in 2008.^[3] In the product records for the Alzheimer's disease psychosis trials, however, the substance has no marketing authorisation and is described as an investigational substance.^[2] The authorisation holder named in these records is Maplight Therapeutics Inc.^[2] In one product record, fesoterodine is part of a fixed combination, which corresponds to the ML-007C-MA product being studied.^[2]

How does fesoterodine work?

The supplementary sources provided do not include a detailed explanation of the mechanism of action of fesoterodine. The prescribing information states that fesoterodine fumarate extended-release tablets are indicated for overactive bladder and neurogenic detrusor overactivity, but the mechanism section is not reproduced in the available source content.^[3] A review article on the safety and tolerability of fesoterodine in older adults with overactive bladder notes that older patients with overactive bladder are more likely to have functional impairment and comorbidity than those without the condition, but does not describe the molecular target of the drug in the provided excerpt.^[5]

Because the mechanism of action is not stated in the provided sources, this section cannot describe how fesoterodine works at the molecular level. The clinical trials in Alzheimer's disease psychosis do not include a mechanism description in their registry records.^[2][1]

Which conditions is it used or studied for?

Fesoterodine is authorised for two conditions, and it is being studied for a third:

• Overactive bladder in adults — a condition with symptoms of urge urinary incontinence, urgency, and frequency.^[3]
• Neurogenic detrusor overactivity in children — in children aged 6 years and older who weigh more than 25 kg.^[3]
• Hallucinations and delusions associated with Alzheimer's disease psychosis — the condition being investigated in the two phase 2 trials, where fesoterodine is part of the fixed combination ML-007C-MA.^[2][1]

How is fesoterodine given?

Fesoterodine is given as a tablet for oral use. The authorised fesoterodine fumarate product is a film-coated, extended-release tablet for oral use.^[3] In the Alzheimer's disease psychosis trials, the product records list the pharmaceutical form as tablet and the route of administration as oral use.^[2][1] The dose used in these trials is 210 mg as part of the ML-007C-MA bilayer tablet.^[2][1]

For the authorised overactive bladder indication, the prescribing information gives a recommended starting dose of 4 mg once daily in adults, which may be increased to a maximum of 8 mg once daily based on individual response and tolerability. For children with neurogenic detrusor overactivity, the dose depends on body weight.^[3]

What do the clinical trials show?

Two phase 2 clinical trials are authorised for fesoterodine as part of the fixed combination ML-007C-MA in adults with hallucinations and delusions associated with Alzheimer's disease psychosis.^[2][1] Both trials are interventional studies, and both are currently in the authorised status, meaning they have been approved but are not yet recruiting or completed.

The first trial, NCT06887192, is a placebo-controlled study that plans to enrol 330 participants. It compares ML-007C-MA with a placebo bilayer tablet. The main outcome measure is the change from baseline to week 7 in the NPI-C H+D score, which is a scale that measures hallucinations and delusions.^[2] The second trial, 2025-521757-16-00, is an open-label study that plans to enrol 221 participants. It evaluates the long-term safety and tolerability of ML-007C-MA, with the main outcome being the incidence of treatment-emergent adverse events, treatment-emergent serious adverse events, and treatment-emergent adverse events leading to study discontinuation.^[1]

Both trials use a 210 mg oral tablet of fesoterodine as part of the combination product. In the placebo-controlled trial, the placebo arm is a bilayer tablet that does not contain the active substance.^[2]

What side effects are known?

The provided sources do not include a detailed list of side effects for fesoterodine. The review article on safety and tolerability in older adults with overactive bladder discusses the topic, but the provided excerpt does not list specific adverse reactions.^[5] The prescribing information for fesoterodine fumarate extended-release tablets includes safety information, but the side effect section is not reproduced in the available content.^[3]

In the open-label Alzheimer's disease psychosis trial, the main outcome measure is the incidence of treatment-emergent adverse events, which will provide safety data for the 210 mg dose used in that study.^[1] The Devon formulary lists fesoterodine fumarate as a second-line drug for urinary frequency, enuresis, and incontinence, but does not provide side effect information in the available content.^[4]