AP707 · program
AP707 for Neuropathic pain
AP707 (adezunap), a sublingual THC nanodispersion spray, for chronic neuropathic pain. Apurano registered six Phase 3 neuropathic-pain trials on ClinicalTrials.gov on 2023-10-10 - paired 14-week efficacy and 52-week long-term studies in each of three populations: chronic pain due to central neuropathy of any genesis (multiple sclerosis, stroke, traumatic brain injury, phantom pain, paraplegia; NCT06071949 / NCT06072001), chronic pain due to traumatic or post-operative peripheral neuropathy (NCT06071936 / NCT06071988), and painful diabetic polyneuropathy (NCT06072573 / NCT06071975) - each randomized, placebo-controlled, ~558 patients (estimated), dosing up to 17.6 mg THC/day across 4 intakes as add-on to standard of care, starting 2023-11-02. All six records have been in CT.gov 'Unknown' status since their last update on 2024-01-31 (last known: Recruiting), the estimated primary completion of 2024-09-30 has passed with no posted results, and no press release or publication reporting outcomes could be found through 2026-08-31 - so program status is recorded honestly as unknown rather than active or discontinued. The company's own site continues to present the Phase 3 program (DISCOVER, EMA-permitted) as current. Two further Phase 3 trials in chronic back pain (NCT06072560, NCT06071962) belong to a separate non-neuropathic indication with no slug in this vocabulary and are not part of this record.
Development timeline
- Date of the last update the sponsor made to any of the Phase 3 registry records. All six records subsequently lapsed into ClinicalTrials.gov 'Unknown' status (last known: Recruiting); the estimated primary completion of 2024-09-30 passed with no posted results and no press release found through 2026-08-31. Registry staleness, not a documented discontinuation - the company site still presents the Phase 3 program as current.
- Six Phase 3 neuropathic-pain trials (plus two in chronic back pain, outside this record) registered 2023-10-10 and started 2023-11-02, sponsored by Apurano Pharmaceuticals GmbH. Program went directly from a single-dose Phase 1 to Phase 3 - no Phase 2 is registered anywhere.
- Trial startedAll six Phase 3 neuropathic-pain trials of AP707 start
- Trial registeredApurano registers six Phase 3 trials of AP707 (adezunap) in chronic neuropathic pain on ClinicalTrials.gov
- SELECT-I (NCT05267769) started: single-dose pharmacokinetics and tolerability of AP707 in 12 healthy volunteers, sponsored by CannaXan GmbH (merged into Apurano Pharmaceuticals GmbH 2023-01-26). Completed 2022-04-03.
Clinical trials in Neuropathic pain
NCT06072573Phase 3Unknownn=558
Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Diabetic Polyneuropathy
NCT06072001Phase 3Unknownn=558
Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Central Neuropathy of Any Genesis
NCT06071975Phase 3Unknownn=558
Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Diabetic Polyneuropathy
NCT06071949Phase 3Unknownn=558
Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Central Neuropathy of Any Genesis
NCT06071936Phase 3Unknownn=558
Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Traumatic or Post-operative Peripheral Neuropathy
NCT06071988Phase 3Unknownn=558
Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Traumatic or Post-operative Peripheral Neuropathy
NCT05267769Phase 1Completedn=12
Clinical Trial on Pharmacokinetics and Tolerability of AP707
Formulations
| Formulation | Route | Regimen | Pharmacokinetics |
|---|---|---|---|
| AP707 sublingual spray (aqueous THC nanodispersion, PuranoTec)PuranoTec aqueous nanodispersion (particle size <250 nm) of a cannabis flower preparation, delivered as a sublingual mouth spray for transmucosal absorption Phase 3 trials dose up to a maximum of 17.6 mg THC per day divided across 4 intakes, as add-on to standard of care over 14-week (efficacy) or 52-week (long-term) treatment periods. Phase 1 (SELECT-I, NCT05267769) was a single oromucosal dose in 12 healthy volunteers. | Sublingual | — | — |
Mechanism of action
The primary active constituent of AP707 is delta-9-tetrahydrocannabinol (THC; dronabinol as the defined single substance, PubChem CID 16078, UNII 7J8897W37S), a partial agonist at both cannabinoid receptors CB1 (CNR1) and CB2 (CNR2), Gi/o-coupled class-A GPCRs. CB1 agonism in central and peripheral pain pathways underlies the analgesic rationale in chronic neuropathic pain; the sponsor describes AP707 as a THC-focused endocannabinoid-system modulator. Because AP707 is a cannabis flower preparation rather than a single chemical entity, minor cannabinoids may be present; no AP707-specific receptor pharmacology has been published, so all receptor characterization here is parent-molecule (THC) literature.
| Target | Action | Affinity |
|---|---|---|
| CB1primaryCNR1 | Partial agonist | —ⓘ |
| CB2CNR2 | Partial agonist | —ⓘ |
← Full AP707 compound page (identity, identifiers, all indications)
Sources
- Apurano - smart bio-nanotechnology (company site: ADEZUNAP/AP707, PuranoTec aqueous nanodispersion <250 nm, sublingual spray, SELECT-I Phase 1 completed, EMA permission for Phase 3 DISCOVER, beleronap pipeline, Warngau HQ) — Apurano Pharmaceuticals GmbH
- CB1 receptor (CNR1), GtoPdb object 56 - delta-9-THC listed as partial agonist — IUPHAR/BPS Guide to PHARMACOLOGY
- CB2 receptor (CNR2), GtoPdb object 57 - delta-9-THC listed as partial agonist — IUPHAR/BPS Guide to PHARMACOLOGY
- NCT05267769 - Clinical Trial on Pharmacokinetics and Tolerability of AP707 (SELECT-I; CannaXan GmbH; completed 2022) — ClinicalTrials.gov (U.S. National Library of Medicine)
- NCT06071936 - Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Traumatic or Post-operative Peripheral Neuropathy — ClinicalTrials.gov (U.S. National Library of Medicine)
- NCT06071949 - Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Central Neuropathy of Any Genesis — ClinicalTrials.gov (U.S. National Library of Medicine)
- NCT06071975 - Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Diabetic Polyneuropathy — ClinicalTrials.gov (U.S. National Library of Medicine)
- NCT06071988 - Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Traumatic or Post-operative Peripheral Neuropathy — ClinicalTrials.gov (U.S. National Library of Medicine)
- NCT06072001 - Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Central Neuropathy of Any Genesis — ClinicalTrials.gov (U.S. National Library of Medicine)
- NCT06072573 - Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Diabetic Polyneuropathy — ClinicalTrials.gov (U.S. National Library of Medicine)