{"article":{"annotation":{"article_id":"fda-seeks-input-on-ibogaine-clinical-trial-design","available_at":"2026-10-06T23:11:44.175858Z","geography_revision":"ef6ee0010dda5fe7b240fd514749b43e214c57da73222d2e40ec83b276dd0977","id":"52ab9ee982f80018b206333adf325e6a7db372047f31b01a7fcb6e51bd84d8f7","input_sha256":"3bab507e90088dc2cae205f5c2641d1417323b532090efd3260f0bb046c25668","limitations":["Rule-derived subjects are candidates, not verified editorial labels or calibrated model probabilities.","Coverage is distinct from event location. Unknown country/city/coordinates remain absent; no automatic geocoding.","Article geometries keep their stated precision and methodology; reproducing them is not independent coordinate verification."],"method":"controlled-rules-v1","places":[{"admin1":null,"city":null,"coordinate_note":null,"coordinate_reference_system":"OGC:CRS84","coordinate_source":null,"country":"US","evidence":[{"field":"country","language":"en","note":"Explicit preserved editorial country/region; no city or national centroid inferred","source_urls":["https://www.fda.gov/news-events/press-announcements/fda-seeks-public-input-support-ibogaine-research"]}],"geometry":null,"id":"iso3166-1:US","kind":"country-or-area","labels":{"ar":"الولايات المتحدة الأمريكية","en":"United States of America","es":"Estados Unidos de América","fr":"États-Unis d’Amérique"},"match_status":"candidate","precision":"regional","role":"coverage","uncertainty_m":null}],"rules_sha256":"d28c9c89703b56bd91fd887965d416d0115c2473d4bfbd3e558bcceafc3941dd","schema_version":1,"subjects":[{"concept_id":"medtop:07000000","confidence":null,"confidence_method":null,"evidence":[{"field":"category+topics","language":"en","note":"Preserved editorial category/topic; broad candidate only","source_urls":["https://www.fda.gov/news-events/press-announcements/fda-seeks-public-input-support-ibogaine-research"]}],"method":"controlled-rules-v1","rule_id":"health-broad","status":"candidate"}],"taxonomy_revision":"1f2db31d811fca07e99b16d402c10e2cc2965c9df1c7b41d9be348b40a24e7fb","taxonomy_version":"IPTC Media Topics 2026-Q2"},"api_url":"https://newsverum.com/api/v1/articles/fda-seeks-input-on-ibogaine-clinical-trial-design?lang=en","category":"health","content":{"key_points":[],"paragraphs":["The FDA issued a request for information on how early-phase clinical trials of ibogaine products should be designed. It is seeking evidence and feedback on patient eligibility, dose escalation, care settings, stopping rules, safety monitoring and independent oversight.","The agency highlighted cardiac and neurologic risks and said a proposed starting dose should be supported by available evidence and not exceed 10 milligrams per kilogram. The request is for input on research design, not an approval of ibogaine treatment; the comment period is scheduled to close November 20, 2026."],"sections":[]},"corrections":[{"at":"2026-10-07T00:52:01+03:00","language":"en","text":"German and Portuguese editions and translations of the data and correction explanations have been added to this article."}],"country":"US","data":{"blocks":[{"description":{"ar":"طلب المعلومات والموعد النهائي الواردان في بيان الإدارة.","de":"Die Informationsanfrage und die in der Mitteilung genannte Frist der FDA.","en":"The FDA information request and deadline stated in the release.","es":"La solicitud de información y el plazo indicados en el comunicado de la FDA.","fr":"La demande d’informations et l’échéance indiquées dans le communiqué de la FDA.","pt":"O pedido de informações e o prazo indicados no comunicado da FDA.","tr":"FDA’nın açıklamasındaki bilgi talebi ve kaynakta belirtilen son tarih."},"id":"ibogaine-rfi-timeline","items":[{"date":"2026-10-05","description":{"ar":"طلب آراء وبيانات بشأن تصميم تجارب الإيبوجاين المبكرة.","de":"Bitte um Stellungnahmen und Daten zur Gestaltung früher Ibogain-Studien.","en":"Request for views and data on early ibogaine trial design.","es":"Solicitud de opiniones y datos sobre ensayos iniciales de ibogaína.","fr":"Demande d’avis et de données sur les premiers essais d’ibogaïne.","pt":"Pedido de opiniões e dados sobre o desenho de estudos iniciais de ibogaína.","tr":"Erken ibogain deneylerinin tasarımı hakkında görüş ve veri çağrısı."},"label":{"ar":"إصدار طلب المعلومات","de":"FDA veröffentlicht Informationsanfrage","en":"FDA information request issued","es":"Publicación de la solicitud de información","fr":"Publication de la demande d’informations","pt":"FDA publica pedido de informações","tr":"FDA bilgi talebi yayımlandı"},"status":"occurred"},{"date":"2026-11-20","description":{"ar":"قالت الإدارة إن التعليقات المتأخرة لن تُؤخذ في الاعتبار.","de":"Laut FDA werden verspätete Stellungnahmen nicht berücksichtigt.","en":"FDA says late comments will not be considered.","es":"La FDA indica que no se considerarán comentarios tardíos.","fr":"La FDA indique que les commentaires tardifs ne seront pas pris en compte.","pt":"A FDA informa que comentários enviados após o prazo não serão considerados.","tr":"FDA, geç yorumların dikkate alınmayacağını belirtti."},"label":{"ar":"إغلاق فترة التعليقات","de":"Kommentierungsfrist endet","en":"Comment period closes","es":"Cierre del periodo de comentarios","fr":"Clôture de la période de commentaires","pt":"Fim do prazo para comentários","tr":"Yorum süresinin kapanması"},"status":"scheduled"}],"methodology":{"ar":"نُقل التاريخ ووصف الإجراء عن بيان الإدارة؛ والموعد المستقبلي محدد في المصدر ولا يعني اعتماد دواء أو نتيجة تجربة.","de":"Datum und Maßnahme wurden von der FDA übernommen. Die künftige Frist stammt aus der Quelle und bedeutet weder eine Arzneimittelzulassung noch ein Studienergebnis.","en":"The date and action are transcribed from FDA. The future deadline is source-stated and does not indicate a drug approval or trial result.","es":"La fecha y el procedimiento proceden de la FDA. El plazo futuro lo fija la fuente y no implica aprobación de un fármaco ni resultado de un ensayo.","fr":"La date et la démarche sont reprises de la FDA. L’échéance future est indiquée par la source et ne signale ni autorisation de médicament ni résultat d’essai.","pt":"A data e a medida foram transcritas da FDA. O prazo futuro é informado pela fonte e não indica aprovação de medicamento nem resultado de estudo.","tr":"Tarih ve işlem açıklaması FDA duyurusundan aktarılmıştır; gelecekteki son tarihi kaynak belirtir ve ilaç onayı ya da deney sonucu anlamına gelmez."},"sourceUrls":["https://www.fda.gov/news-events/press-announcements/fda-seeks-public-input-support-ibogaine-research"],"title":{"ar":"طلب المعلومات وجدول التعليقات لدى الإدارة","de":"Informationsanfrage der FDA und Frist für Stellungnahmen","en":"FDA information request and comment timeline","es":"Solicitud de información de la FDA y plazo de comentarios","fr":"Demande d’informations de la FDA et calendrier des commentaires","pt":"Pedido de informações da FDA e prazo para comentários","tr":"FDA bilgi talebi ve yorum takvimi"},"type":"events","updatedAt":"2026-10-07T00:52:01+03:00"}],"version":1},"data_downloads":[{"formats":{"csv":"https://newsverum.com/api/v1/articles/fda-seeks-input-on-ibogaine-clinical-trial-design/data/ibogaine-rfi-timeline?lang=en&format=csv","json":"https://newsverum.com/api/v1/articles/fda-seeks-input-on-ibogaine-clinical-trial-design/data/ibogaine-rfi-timeline?lang=en&format=json"},"id":"ibogaine-rfi-timeline"}],"data_types":["events"],"editorial_illustration":{"alt":"Conceptual illustration of public health, research and connected data.","asset_id":"newsverum-v1-health","avif_variants":[{"height":320,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-480.avif","width":480},{"height":480,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-720.avif","width":720},{"height":640,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-960.avif","width":960},{"height":800,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-1200.avif","width":1200},{"height":1024,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-1536.avif","width":1536}],"credit":"Newsverum","documentary":false,"height":1024,"kind":"symbolic-editorial-illustration","language":"en","scope":"topic","url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-1536.webp","variants":[{"height":320,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-480.webp","width":480},{"height":640,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-960.webp","width":960},{"height":1024,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-1536.webp","width":1536}],"width":1536},"event_id":"event-87987f42-68ad-5dee-89b2-ce35761b96ee","event_period":"2026-10-05","event_period_basis":"event-or-reference-period","id":"fda-seeks-input-on-ibogaine-clinical-trial-design","image":null,"importance":0.6,"language":"en","modified_at":"2026-10-07T00:52:01+03:00","publication_basis":"publication-record","published_at":"2026-10-06T17:58:49+00:00","reading_minutes":1,"region":"world","section_illustration":{"alt":"Conceptual illustration of public health, research and connected data.","asset_id":"newsverum-v1-health","avif_variants":[{"height":320,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-480.avif","width":480},{"height":480,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-720.avif","width":720},{"height":640,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-960.avif","width":960},{"height":800,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-1200.avif","width":1200},{"height":1024,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-1536.avif","width":1536}],"credit":"Newsverum","documentary":false,"height":1024,"kind":"symbolic-editorial-illustration","language":"en","scope":"section","url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-1536.webp","variants":[{"height":320,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-480.webp","width":480},{"height":640,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-960.webp","width":960},{"height":1024,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-1536.webp","width":1536}],"width":1536},"slug":"fda-seeks-input-on-ibogaine-clinical-trial-design","sources":[{"checkedAt":"2026-10-06","name":"U.S. Food and Drug Administration","publishedAt":"2026-10-05","url":"https://www.fda.gov/news-events/press-announcements/fda-seeks-public-input-support-ibogaine-research"}],"summary":"The agency is asking about trial design, dosing, safety monitoring and oversight, with comments due November 20.","text":"The agency is asking about trial design, dosing, safety monitoring and oversight, with comments due November 20.\n\nThe FDA issued a request for information on how early-phase clinical trials of ibogaine products should be designed. It is seeking evidence and feedback on patient eligibility, dose escalation, care settings, stopping rules, safety monitoring and independent oversight.\n\nThe agency highlighted cardiac and neurologic risks and said a proposed starting dose should be supported by available evidence and not exceed 10 milligrams per kilogram. The request is for input on research design, not an approval of ibogaine treatment; the comment period is scheduled to close November 20, 2026.\n\nGerman and Portuguese editions and translations of the data and correction explanations have been added to this article.","title":"FDA seeks input on safeguards for early ibogaine trials","topics":[],"translations":[{"api_url":"https://newsverum.com/api/v1/articles/fda-seeks-input-on-ibogaine-clinical-trial-design?lang=tr","language":"tr","url":"https://newsverum.com/tr/news/fda-seeks-input-on-ibogaine-clinical-trial-design"},{"api_url":"https://newsverum.com/api/v1/articles/fda-seeks-input-on-ibogaine-clinical-trial-design?lang=en","language":"en","url":"https://newsverum.com/en/news/fda-seeks-input-on-ibogaine-clinical-trial-design"},{"api_url":"https://newsverum.com/api/v1/articles/fda-seeks-input-on-ibogaine-clinical-trial-design?lang=ar","language":"ar","url":"https://newsverum.com/ar/news/fda-seeks-input-on-ibogaine-clinical-trial-design"},{"api_url":"https://newsverum.com/api/v1/articles/fda-seeks-input-on-ibogaine-clinical-trial-design?lang=fr","language":"fr","url":"https://newsverum.com/fr/news/fda-seeks-input-on-ibogaine-clinical-trial-design"},{"api_url":"https://newsverum.com/api/v1/articles/fda-seeks-input-on-ibogaine-clinical-trial-design?lang=es","language":"es","url":"https://newsverum.com/es/news/fda-seeks-input-on-ibogaine-clinical-trial-design"},{"api_url":"https://newsverum.com/api/v1/articles/fda-seeks-input-on-ibogaine-clinical-trial-design?lang=de","language":"de","url":"https://newsverum.com/de/news/fda-seeks-input-on-ibogaine-clinical-trial-design"},{"api_url":"https://newsverum.com/api/v1/articles/fda-seeks-input-on-ibogaine-clinical-trial-design?lang=pt","language":"pt","url":"https://newsverum.com/pt/news/fda-seeks-input-on-ibogaine-clinical-trial-design"}],"url":"https://newsverum.com/en/news/fda-seeks-input-on-ibogaine-clinical-trial-design"},"version":"1"}