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comp-027 — Disulfiram Dose Modeling Summary

Headline: GREEN — sub-AUD GSDMD-dominant window EXISTS under the conservative cell-free EC50 anchor.

Recommended 503A dose range (mg/day): 100 - 100

Per-dose dose-response

Dose (mg/d) Cmax parent DSF (μM) Cmax total DTC (μM) Me-DTC peak (nM) GSDMD block (parent, conservative) GSDMD block (total DTC) NLRP3-palm block (parent) ALDH inhibition Verdict
25 0.10 [0.04-0.25] 0.4 17 25% 57% 1.0% 14% RED_below_GSDMD_threshold
50 0.20 [0.08-0.50] 0.8 35 40% 73% 2.0% 25% YELLOW
62.5 0.25 [0.10-0.62] 1.0 43 46% 77% 2.4% 29% YELLOW
100 0.40 [0.16-1.00] 1.6 70 57% 84% 3.8% 40% GREEN
125 0.50 [0.20-1.25] 2.0 87 62% 87% 4.8% 45% YELLOW
200 0.80 [0.32-2.00] 3.2 139 73% 91% 7.4% 57% RED_above_DER_threshold
250 1.00 [0.40-2.50] 4.0 174 77% 93% 9.1% 62% RED_above_DER_threshold
500 2.00 [0.80-5.00] 8.0 348 87% 96% 16.7% 77% RED_above_DER_threshold
1000 4.00 [1.60-10.00] 16.0 695 93% 98% 28.6% 87% RED_above_DER_threshold
2000 10.22 [4.09-25.55] 40.9 1775 97% 99% 50.5% 94% RED_above_DER_threshold

Window summary

  • GREEN doses (mg/d): [100]
  • YELLOW doses (mg/d): [50, 62.5, 125]
  • RED-below-GSDMD-threshold (mg/d): [25]
  • RED-above-DER-threshold (mg/d): [200, 250, 500, 1000, 2000]

Key assumptions and load-bearing anchors

  • DSF PK: Lee 2018 PMC6379104 (CL=0.53 L/hr, Vd=1.3 L, F=0.875).
  • Me-DTC PK: Johansson 1989 PMID 2551696 (278 nM peak at 400 mg).
  • GSDMD EC50 (conservative): 0.30 μM cell-free liposome — Hu 2020 PMC7316630.
  • GSDMD EC50 (optimistic): 0.02 μM cellular preincub — Hu 2020.
  • NLRP3-palmitoylation EC50: 10 μM partial / 30 μM complete — Xu 2024 PMC11398858.
  • ALDH EC50: 104 nM Me-DTC (calibrated to Faiman 1989 PMID 2537080 hypotension threshold).
  • DER hypotension threshold: 40% ALDH inhibition (Faiman 1989).

Anchored verdict thresholds: - GREEN: GSDMD blockade ≥ 50% AND ALDH inhibition ≤ 40% - YELLOW: GSDMD blockade ≥ 30% AND ALDH inhibition ≤ 50% - RED: outside either bound