September 18, 2026 — The European Medicines Agency's human medicines committee (CHMP) has finalised its review of medicines containing ipidacrine, used in adults to treat various nervous system conditions, and recommended restricting their approved uses to better align with available evidence and current clinical practice.
Revised Indications
Under the new recommendations, ipidacrine medicines may now only be used for:
Symptomatic treatment of acquired mononeuropathies and polyneuropathies
Adjunctive symptomatic treatment of myasthenia gravis
Symptomatic treatment of mild to moderately severe Alzheimer's disease
Symptomatic treatment of intestinal atony
Adjunctive treatment in patients recovering from stroke or traumatic brain injury
The committee recommended that ipidacrine should no longer be used for neuritis, polyneuritis, polyradiculoneuropathy, myasthenic syndrome, or demyelinating diseases, citing limited data supporting benefits and changes in standard of care.
Safety Considerations
While no new safety concerns were identified, the CHMP noted an increased risk of side effects at high doses and a potential risk of liver toxicity. Caution is advised for daily doses exceeding 80 mg and in patients with a history of liver problems.
Prescribing Restrictions
Ipidacrine should only be prescribed by physicians experienced in diagnosing and treating the relevant conditions.
Background
Ipidacrine-containing medicines have been authorised in several EU countries since 1997, including Austria, Bulgaria, Croatia, Finland, Hungary, Latvia, Lithuania, Norway, Poland, Romania, Slovakia and Slovenia. They are available as oral tablets and injectable formulations under brand names including Ipidacrine Grindeks, Ipigriks, and Neiromidin.
