EMB-001 · program

EMB-001 (metyrapone/oxazepam) for Tobacco use disorder

DiscontinuedDiscontinuedEmbera NeuroTherapeutics, Inc.

Indications for EMB-001: Cocaine use disorder · Phase 2 Tobacco use disorder · Discontinued

EMB-001 (metyrapone/oxazepam) for smoking cessation / tobacco use disorder. Phase 1 safety/PK was run in otherwise healthy regular smokers (NCT02406066, 2015). An open-label Phase 1/2 ('Phase 2a') study at Rose Research Center, North Carolina (NCT04933916; 720/24 mg BID for 12 weeks; funded by the Foundation for a Smoke-Free World and a $1.3M investor financing) dosed its first subject in June 2021 with topline guided for Q1 2022, but was terminated for a business decision after enrolling 16 of up to 50 subjects (completed 2023-05-01). No efficacy results have been posted or announced.

Data current as of

Development timeline

DiscontinuedMay 2023
  1. NCT04933916 terminated, why stopped: 'Business decision' (16 enrolled). Inferred program discontinuation; no formal company statement.
  2. Trial terminatedEMB-001 smoking cessation study terminated (business decision)
Phase 1/2Jun 2021 – Jun 2021
  1. FinancingEmbera discloses $1.3 million financing from current investors↗
  2. Open-label smoking cessation study NCT04933916 started (registered Phase 1/Phase 2; company calls it Phase 2a). First subject dosed announced 2021-06-30.
  3. Trial startedOpen-label Phase 2a study of EMB-001 in smoking cessation starts
Phase 1Mar 2015 – Jun 2020
  1. FinancingEmbera completes $1.2 million Series B financing↗
  2. Phase 1 SAD/MAD in otherwise healthy regular cigarette smokers (NCT02406066) started March 2015 (month precision).

Clinical trials in Tobacco use disorder

NCT04933916ERL-T002Phase 1/2Discontinuedn=16

Efficacy and Safety of Combination EMB-001 as a Potential Smoking Cessation Treatment

Started Jun 2021· Primary completion Apr 2023· 📍 2 sites across 1 country (United States)

NCT04868253ERL-T002Phase 2/3Unknownn=25

Efficacy and Safety of Combination EMB-001 as a Potential Smoking Cessation Treatment

Started May 2021· Primary completion Dec 2021· 📍 1 site across 1 country (United States)

NCT02406066ERL-001Phase 1Completedn=24

Phase 1 Combined Single and Multiple Rising Dose Study of the Safety and Pharmacokinetics of Metyrapone/Oxazepam Combination (EMB-001)

Started Mar 2015· Primary completion Dec 2015· 📍 2 sites across 1 country (United States)

Formulations

FormulationRouteRegimenPharmacokinetics
EMB-001 oral capsule (metyrapone 720 mg / oxazepam 24 mg twice daily)
Phase 2 cocaine use disorder: 720 mg metyrapone / 24 mg oxazepam PO BID for 12 weeks then 1-week taper (NCT04501874). Smoking study: same dose BID, total daily 1440 mg metyrapone / 48 mg oxazepam (NCT04933916); the Rose Research Center registration describes 240 mg/8 mg capsules, 3 capsules per dose (NCT04868253). Phase 1 SAD/MAD in smokers: 270/12, 540/24 and 720/24 mg BID for ~1 week (NCT02406066).
OralTwice daily—

Mechanism of action (compound-wide)

Dual mechanism aimed at the stress response implicated in relapse: metyrapone inhibits adrenal 11-beta-hydroxylase (CYP11B1), the final step of cortisol synthesis, lowering stress-driven cortisol; oxazepam is a benzodiazepine that positively modulates GABA-A receptors (anxiolytic). Sponsor describes it as reducing drug-, cue- and stressor-induced stress-system activity that contributes to relapse.

TargetActionAffinity
CYP11B1primaryCYP11B1Inhibitor—ⓘ
GABA-A receptorPAM—ⓘ

← Full EMB-001 compound page (identity, identifiers, all indications)

Sources

  1. Embera NeuroTherapeutics Announces First Subject Dosed in Phase 2 Study of EMB-001 in Cocaine Use Disorder (2020-08-31) — Embera NeuroTherapeutics (Business Wire via BioSpace)
  2. Embera NeuroTherapeutics Announces First Subject Dosed in Phase 2a Study of EMB-001 in Smoking Cessation (2021-06-30) — Embera NeuroTherapeutics (Business Wire via BioSpace)
  3. NCT02406066 (ERL-001) - Phase 1 SAD/MAD of EMB-001 in smokers — ClinicalTrials.gov (U.S. National Library of Medicine)
  4. NCT04501874 (ERL-003) - Phase 2 EMB-001 in moderate-to-severe cocaine use disorder (results posted 2026-09-21) — ClinicalTrials.gov (U.S. National Library of Medicine)
  5. NCT04868253 (ERL-T002) - EMB-001 smoking cessation, Rose Research Center registration — ClinicalTrials.gov (U.S. National Library of Medicine)
  6. NCT04933916 (ERL-T002) - EMB-001 smoking cessation, terminated (business decision) — ClinicalTrials.gov (U.S. National Library of Medicine)
  7. PDB 7E7F - Human CYP11B1 mutant in complex with metyrapone (PMID 34485929) — RCSB Protein Data Bank