id,agency_id,docket_id,title,document_type,subtype,posted_date,posted_year,posted_month,comment_start_date,comment_end_date,last_modified,fr_doc_num,open_for_comment,withdrawn,object_id
FDA-2026-N-10429-0002,FDA,FDA-2026-N-10429,"Reference 1 - Alper, K.R., Stajic´, M., and J.R. Gill, ‘‘Fatalities temporally associated with the ingestion of ibogaine,’’ J. Forensic Sci., 57(2):398–412 (2012), available at doi:10.1111/j.1556-4029.2011.02008.x.",Supporting & Related Material,Background Material,2026-10-06T04:00:00Z,2026,10,,,2026-10-06T20:44:11Z,,0,0,09000064b9635d74
FDA-2026-N-10429-0003,FDA,FDA-2026-N-10429,"Reference 2 - Brunt, T.M., ‘‘Rare but relevant: ibogaine and cardiovascular complications— prolonged QT interval and ventricular arrhythmias,’’ Addiction, 121(6):1616– 1621 (2026), available at doi:10.1111/add.70319.",Supporting & Related Material,Background Material,2026-10-06T04:00:00Z,2026,10,,,2026-10-06T20:44:30Z,,0,0,09000064b9635d75
FDA-2026-N-10429-0005,FDA,FDA-2026-N-10429,"Reference 4 - Knuijver, T., ter Heine, R., Schellekens, A.F.A., Heydari, P., Lucas, L., et al., ‘‘The pharmacokinetics and pharmacodynamics of ibogaine in opioid use disorder patients,’’ J. Psychopharmacol., 38(5):481–488 (2024),
available at doi:10.1177/02698811241237873.",Supporting & Related Material,Background Material,2026-10-06T04:00:00Z,2026,10,,,2026-10-06T20:44:37Z,,0,0,09000064b9635d77
FDA-2026-N-10429-0004,FDA,FDA-2026-N-10429,"Reference 3 - Knuijver, T., Schellekens, A., Belgers, M., Donders, R., van Oosteren, T., et al., ‘‘Safety of ibogaine administration in detoxification of opioid-dependent individuals: a descriptive open-label observational study,’’ Addiction, 117(1):118–128 (2022), available at doi:10.1111/add.15448.",Supporting & Related Material,Background Material,2026-10-06T04:00:00Z,2026,10,,,2026-10-06T20:44:33Z,,0,0,09000064b9635d76
FDA-2026-N-10429-0009,FDA,FDA-2026-N-10429,"Reference 8 - Rocha, J.M., Reis, J.A.S., Bouso, J.C., Hallak, J.E.C., and R.G. Dos Santos, ‘‘Identifying setting factors associated with improved ibogaine safety: a systematic review of clinical studies,’’ Eur. Arch. Psychiatry Clin. Neurosci., 273(7):1527–1542 (2023), available at doi:10.1007/s00406-023-01590-1.",Supporting & Related Material,Background Material,2026-10-06T04:00:00Z,2026,10,,,2026-10-06T20:44:48Z,,0,0,09000064b9637d4e
FDA-2026-N-10429-0008,FDA,FDA-2026-N-10429,"Reference 7 - Roden, D.M., ‘‘Drug-induced prolongation of the QT interval,’’ N. Engl. J. Med., 350(10):1013–1022 (2004), available at doi:10.1056/NEJMra032426.",Supporting & Related Material,Background Material,2026-10-06T04:00:00Z,2026,10,,,2026-10-07T23:57:35Z,,0,0,09000064b9637d4d
FDA-2026-N-10429-0006,FDA,FDA-2026-N-10429,"Reference 5 - Kock, P., Froelich, K., Walter, M., Lang, U., and K.M. Du¨ rsteler, ‘‘A systematic literature review of clinical trials and therapeutic applications of ibogaine,’’ J. Subst. Abuse Treat., 138:108717 (2022), available at doi:10.1016/j.jsat.2021.108717.",Supporting & Related Material,Background Material,2026-10-06T04:00:00Z,2026,10,,,2026-10-06T20:44:40Z,,0,0,09000064b9635d78
FDA-2026-N-10429-0007,FDA,FDA-2026-N-10429,"Reference 6. - Ona, G., Rocha, J.M., Bouso, J.C., Hallak, J.E.C., Borra`s, T., et al., ‘‘The adverse events of ibogaine in humans: an updated systematic review of the literature (2015–2020),’’ Psychopharmacology, 239(6):1977–1987
(2022), available at doi:10.1007/s00213-021-05964-y.",Supporting & Related Material,Background Material,2026-10-06T04:00:00Z,2026,10,,,2026-10-06T20:44:43Z,,0,0,09000064b9635d79
FDA-2026-N-10429-0001,FDA,FDA-2026-N-10429,Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information,Notice,Requests for Information (RFI),2026-10-06T04:00:00Z,2026,10,2026-10-06T04:00:00Z,2026-11-21T04:59:59Z,2026-10-15T09:00:40Z,2026-20427,1,0,09000064b962e7b9