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Sepranolone has achieved an excellent safety profile in repeated studies. In phase IIa and IIb trials for PMDD it was administered to hundreds of women in thousands of doses—with no severe adverse effects. Minor adverse effects were primarily slight skin irritations. The compound’s targeted specificity is key to its excellent safety record.

Sepranolone’s inhibitory effect is highly specific to ALLO—so it does not interfere with GABA itself or other GABA agonists’ effect on the receptor (e.g. benzodiazepines) (1).

Early research into Sepranolone on mouse models of Tourette symptoms, for example, highlights its potential to reduce tics with the same efficacy as today’s most efficacious current therap (Haldol), but none of its serious side effects. (Haldol’s side effects range from blurred vision, nausea and diarrhoea to severe involuntary movement disorder, irregular heartbeat and even renal failure.)

“I’m totally convinced Sepranolone is safe and has no side effects. I believe in its safety profile.”

Prof Marie Bixo, University of Umeå, Lead study Investigator, phase IIa study for Sepranolone for PMDD.