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PP-01
- Development stage
- Phase 3
- Lead developer
- PleoPharma
- Modality
- Small Molecules
- Administration
- Oral
01
Overview
**PP-01** is PleoPharma's investigational, once-daily oral fixed-dose combination of nabilone and gabapentin for mitigating cannabis withdrawal symptoms in adults with moderate to severe cannabis use disorder. Nabilone is intended to address suppressed cannabinoid receptor 1 signaling, while gabapentin is intended to modulate neurotransmitter dysregulation in the mesolimbic reward pathway. PP-01 completed Phase 2b evaluation and entered a pivotal Phase 3 program in June 2026; it has received FDA Fast Track designation for cannabis withdrawal symptoms in patients with cannabis use disorder. ([pleopharma.com](https://www.pleopharma.com/post/pleopharma-inc-presents-positive-cannabis-withdrawal-clinical-trial-results-at-aaap-annual-meeting))
- Other names
- nabilone + gabapentinnabilone/gabapentin
02
Targets
α2δ (Voltage-gated calcium channel alpha-2-delta subunit)CNR1 (Cannabinoid receptor 1)
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