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AXS-12

Research only

cataplexy in narcolepsy

Published evidence

2 publications0 exact-program2 related3 context / correction notes

Review publications

Program details

Sponsor identifies AXS-12 as reboxetine and reports a May 1, 2027 FDA target for cataplexy in narcolepsy.

Program names
AXS-12 / reboxetine
Modality
Small molecule
Indication
cataplexy in narcolepsy
Associated trial
NCT05059223
FDA target
May 1, 2027Date-only guidance; not a trading cutoff.

Publications 2

Evidence is grouped by its relationship to this program.

Search PubMed

Publication notes explain the evidence behind this program. PubMed / NCBI data notice

Coverage & interpretation
  • The bounded AXS-12/reboxetine-narcolepsy query returned no modern branded AXS-12 phase 3 results paper.
  • Selected evidence is an older human pilot and a mouse-model study; neither substitutes for the current clinical dossier.

No exact-program publication is linked here yet. Follow the registry and PubMed sources to explore further.

Same compound & related evidence

2 records
Same compoundhuman clinicalPMID 11322710

Stimulant and anticataplectic effects of reboxetine in patients with narcolepsy: a pilot study.

Sleep · 2001-05-01

An open-label, two-week pilot treated 12 people with narcolepsy using reboxetine. Sleepiness and cataplexy measures improved in this small uncontrolled study; it cannot substitute for a modern randomized AXS-12 trial.

Program relevance

An early reboxetine narcolepsy pilot predates the branded AXS-12 program and is not its modern phase 3 trial.

Formulation / population: Oral reboxetine; the paper does not establish the later branded AXS-12 formulation.

  • Small open-label pilot published in 2001.
  • Predates the branded AXS-12 program.

Journal Article

Same compoundpreclinicalPMID 27118715

The norepinephrine reuptake inhibitor reboxetine is more potent in treating murine narcoleptic episodes than the serotonin reuptake inhibitor escitalopram.

Behavioural brain research · 2016-04-23

In orexin-deficient mice, reboxetine and escitalopram reduced narcoleptic episodes, with reboxetine active at lower doses in this model. This supports a mechanistic hypothesis about norepinephrine signaling, not human treatment efficacy.

Program relevance

Reboxetine was tested in a mouse narcolepsy model, not in a human AXS-12 study.

Formulation / population: Reboxetine administered in an orexin-deficient mouse model.

  • Mouse model; not human clinical efficacy evidence.

Journal Article

Sources

Publication and retrieval dates are shown separately. Market rules determine which evidence can resolve an outcome.

sec-filingwww.sec.gov
Sponsor identifies AXS-12 as reboxetine and reports a May 1, 2027 FDA target for cataplexy in narcolepsy.
Published
Jul 15, 2026
Retrieved
2026-10-30 02:09:48 UTC
sponsor-programwww.axsome.com
Sponsor identifies reboxetine as a norepinephrine reuptake inhibitor being developed for narcolepsy.
Published
Not supplied
Retrieved
2026-10-30 02:09:48 UTC
clinical-trial-registryclinicaltrials.gov
Registry identifies a placebo-controlled AXS-12 narcolepsy study sponsored by Axsome.
Published
Not supplied
Retrieved
2026-10-30 02:09:48 UTC

Research identity and publications do not establish regulatory approval, clinical suitability or an executable market. Read the limits