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Bavisant started life at Johnson & Johnson as JNJ-31001074, a potent, brain-penetrant histamine H3 antagonist aimed at adult ADHD; a controlled dose-ranging trial found it did not produce a clinically meaningful benefit over placebo, and J&J's ADHD program quietly closed. The molecule's story did not end there. BenevolentAI, an AI-driven drug discovery company, later licensed the same compound, renamed it bavisant, and repositioned it around a side effect noted in the original data, dose-dependent insomnia, betting that the same wake-promoting H3 blockade could help excessive daytime sleepiness in Parkinson's disease instead. That reran the drug through a Phase IIb trial testing three doses against placebo in roughly 230 Parkinson's patients, an unusually direct case of an abandoned CNS candidate getting a second clinical life through indication-hopping rather than fresh chemistry.
- wake-promoting, alertness-boosting effects consistent with H3 receptor blockade
- high brain penetrance and oral bioavailability
- being tested specifically for excessive daytime sleepiness in Parkinson's disease
- well characterized receptor binding and selectivity profile
- dose-dependent insomnia, the same effect now being repurposed as its intended benefit
- Bavisant is being developed for the opposite framing of its original side effect: the dose-dependent insomnia that hurt it as an ADHD drug is exactly the wake-promoting property researchers now want for Parkinson's daytime sleepiness.
Mechanism
Potent, selective, orally active H3 receptor (Ki ~5.4 nM) that crosses into the brain; blocking presynaptic H3 autoreceptors increases histamine and downstream monoamine release, promoting wakefulness and alertness.
Safetyrisks and cautions, not medical advice
At 10 mg a day almost one in five participants stopped the drug because of side effects, against fewer than one in thirty on placebo, and 89 percent reported some adverse event compared with 59 percent on placebo. The two lower doses behaved very differently, discontinuing 4.4 percent at 1 mg and 7.4 percent at 3 mg, roughly matching atomoxetine and methylphenidate in the same study. So the dose-limiting problem is steep and it sits between 3 mg and 10 mg. Insomnia is the expected complaint from a wake-promoting H3 blocker, and it is now the effect being deliberately used.
History
Discovered by Johnson & Johnson as JNJ-31001074 and tested in a Phase II adult ADHD trial (NCT00880217) that failed to show clinically meaningful benefit; later licensed by BenevolentAI, renamed bavisant, and advanced into a Phase IIb dose-ranging trial (NCT03194217) for excessive daytime sleepiness in Parkinson's disease.
Subjective profileweighing the evidence above
A rare example of a failed ADHD candidate getting resurrected for an entirely different indication by leaning into its own side effect.
Resources
This entry is here for reference.
Reviews
My notesprivate to this device
FAQ
Is bavisant the same compound as JNJ-31001074?
Yes. Bavisant is the renamed version of Johnson & Johnson's JNJ-31001074, later licensed by BenevolentAI for a new indication.
Why did the ADHD program fail?
The controlled trial did not show a clinically meaningful improvement over placebo, even though the drug's H3 receptor engagement and wake-promoting activity were well documented.
Limitations of the evidence
- did not show clinically meaningful benefit in its original ADHD trial
- no drug has yet reached approval, so long-term human safety data remains limited
Adverse effects
- dose-dependent insomnia, the same effect now being repurposed as its intended benefit