Juq-097 ◉ (FRESH)

"JUQ-097" is a title released under the Madonna label, a studio renowned for its focus on the "mature woman" (jukujo) genre. The film features Yumi Kazama, a prominent and long-standing figure in the AV industry known for her versatility and commanding screen presence. The production fits squarely into the studio's aesthetic of high-quality, narrative-driven adult films focusing on older women.

| Phase | Design | Enrollment | Status | Key Outcomes | |-------|--------|------------|--------|--------------| | Phase I (US/Europe) | Single‑ascending dose (SAD) & multiple‑ascending dose (MAD) in healthy volunteers. | 96 | Completed 2023 | • Linear PK, t½ ≈ 9 h.
• No serious AEs.
• Max tolerated dose = 120 mg qd. | | Phase Ib (AUD) | Randomized, double‑blind, 2‑week lead‑in, 4‑week treatment. 30 mg vs. placebo. | 48 (moderate‑severity AUD) | Completed 2024 | • Primary: % heavy‑drinking days ↓ 27 % vs. 5 % placebo (p = 0.004).
• Secondary: Craving VAS ↓ 34 % (p = 0.001). | | Phase IIa (AUD + MDD) | 12‑week, 2‑arm (30 mg vs. 60 mg) with standard psychosocial counseling. | 210 (AUD + comorbid MDD) | Ongoing – Interim analysis (Week 8) | • Trend toward greater abstinence rates (60 % vs. 45 % placebo).
• PHQ‑9 reduction of 5 points vs. 2 points (p = 0.02). | | Phase IIb/III (planned) | Global, multicenter, 24‑week, 3 arms (30 mg, 60 mg, placebo). Primary endpoint: % days abstinent; key secondary: relapse‑free survival, depressive symptom remission. | ~1,200 (target) | Recruitment slated for Q4 2026 | — | JUQ-097

Note: The US FDA granted Fast‑Track designation (Sept 2024) and Breakthrough Therapy status (Jan 2025) based on Phase Ib data. "JUQ-097" is a title released under the Madonna

| Area | Open Question | Planned/Proposed Study | |------|---------------|------------------------| | Broad addiction spectrum | Does NOP antagonism reduce opioid or stimulant relapse? | Phase IIb exploratory arm in opioid‑use disorder (OUD) slated for 2027. | | Neuroimaging biomarkers | Which brain circuits show occupancy‑linked changes? | PET ligand (NOP‑specific) study using [¹⁸F]‑JNJ‑54175446, recruiting 30 AUD patients (2026). | | Precision medicine | Are there genetic polymorphisms (OPRL1) that predict response? | Genome‑wide association sub‑analysis of Phase II data. | | Long‑term safety | Effects beyond 12 months, especially on mood and cognition? | Open‑label extension (OLE) up to 24 months (ongoing). | | Combination with Naltrexone | Additive or synergistic anti‑craving? | Small‑scale crossover trial (n = 40) planned for late 2026. | | Area | Open Question | Planned/Proposed Study