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Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information

Published . Updated .

The Food and Drug Administration (FDA or the Agency) is describing the approaches it is considering for the design of early- phase clinical trials of ibogaine drug products and is opening a public docket to receive comments. The Department of Health and Human Services (HHS) is funding clinical development of ibogaine, and the first federally supported trials are expected to study ibogaine in adults with opioid use disorder (OUD) and adults with post-traumatic stress disorder (PTSD). FDA is building on the guidance for industry entitled "Psychedelic Drugs: Considerations for Clinical Investigations" by seeking comments, data, and information from the public on protocol elements relevant to ibogaine development--including dose selection and escalation, care setting, safety monitoring, eligibility criteria, stopping rules, and safety oversight, in part, because the Federal Government is funding work in this area. FDA will consider all information provided in response to this Request for Information (RFI) to inform whether and how these specific elements should be considered in its review of Investigational New Drug Applications (INDs) involving ibogaine.

Directly affected

  • No company is named in this report.

Indirectly affected

  • XLV Health Care Select Sector SPDR

    A fund of health-care companies

  • XBI SPDR S&P Biotech

    A fund of biotechnology companies

  • UNH UnitedHealth

    A large health insurer

  • JNJ Johnson & Johnson

    A large health-care company

  • LLY Eli Lilly

    A large drug maker

  • PFE Pfizer

    A large drug maker

  • ACHC ACADIA HEALTHCARE COMPANY INC

    GA selected ACHC as a RELATED security because its canonical security name directly matches this event's themes: healthcare. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article.

  • ASND ASCENDIS PHARMA A/S

    GA selected ASND as a RELATED security because its canonical security name directly matches this event's themes: pharma. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article.

  • ATYR ATYR PHARMA INC COM NEW

    GA selected ATYR as a RELATED security because its canonical security name directly matches this event's themes: pharma. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article.

  • GEHC GE HEALTHCARE TECHNOLOGIES I

    GA selected GEHC as a RELATED security because its canonical security name directly matches this event's themes: healthcare. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article.

Price reaction, T-5 to T+3

TickerT-5T-3T-1T0T+1T+2T+3
XLV———————
XBI———————
UNH———————
JNJ———————
LLY———————
PFE———————
ACHC———————
ASND———————
ATYR———————
GEHC———————

The Food and Drug Administration (FDA or the Agency) is describing the approaches it is considering for the design of early- phase clinical trials of ibogaine drug products and is opening a public docket to receive comments. The Department…

Source: Federal Register

How far Acadia Healthcare (ACHC) has moved since 6 Oct 2026

Since the first closing price after “Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information,” Acadia Healthcare (ACHC) is +3.28%. The S&P 500 fund (SPY) is -1.36% over the same days, a +4.64% difference versus the market.

ACHC
SPY

Official trades in Acadia Healthcare (ACHC) around 6 Oct 2026

Public disclosure filings, not a recommendation. The filing link is the source document. News use of these reports still sits under 5 U.S.C. § 13107(c).

Who gains and who loses around Acadia Healthcare (ACHC)

Companies tied to this story

  • ACHC Acadia Healthcare

    Acadia Healthcare (ACHC) is linked, with no stored direction, medium confidence in the 6 Oct 2026 story “Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information.” Reason on file: GA selected ACHC as a RELATED security because its canonical security name directly matches this event's themes: healthcare. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article

  • ASND Ascendis Pharma A/S

    In “Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information,” Ascendis Pharma A/S (ASND) is linked, with no stored direction, medium confidence. Reason on file: GA selected ASND as a RELATED security because its canonical security name directly matches this event's themes: pharma. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article

  • ATYR aTYR PHARMA

    In “Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information,” aTYR PHARMA (ATYR) is linked, with no stored direction, medium confidence. Reason on file: GA selected ATYR as a RELATED security because its canonical security name directly matches this event's themes: pharma. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article

  • GEHC GE HealthCare Technologies

    In “Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information,” GE HealthCare Technologies (GEHC) is linked, with no stored direction, medium confidence. Reason on file: GA selected GEHC as a RELATED security because its canonical security name directly matches this event's themes: healthcare. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article

  • BBIO BridgeBio Pharma

    For “Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information,” BridgeBio Pharma (BBIO) is linked, with no stored direction, medium confidence. Reason on file: GA selected BBIO as a RELATED security because its canonical security name directly matches this event's themes: pharma. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article

  • DVA Davita

    For “Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information,” Davita (DVA) is linked, with no stored direction, medium confidence. Reason on file: GA selected DVA as a RELATED security because its canonical security name directly matches this event's themes: healthcare. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article

Acadia Healthcare (ACHC)

“Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information” (6 Oct 2026) reaches Acadia Healthcare (ACHC) through this story.

The link for Acadia Healthcare (ACHC) is this: GA selected ACHC as a RELATED security because its canonical security name directly matches this event's themes: healthcare. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article

A second company, Ascendis Pharma A/S (ASND), is listed for a different reason: GA selected ASND as a RELATED security because its canonical security name directly matches this event's themes: pharma. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article

The price range for Acadia Healthcare (ACHC), and the dates in the story

ACHC traded between 26.75 and 32.03 across 20 sessions. The latest close on file is 30.20. ASND traded between 219.69 and 240.84 across 20 sessions. The latest close on file is 229.99. ATYR traded between 0.17 and 0.41 across 20 sessions. The latest close on file is 0.17.

A simple score for Acadia Healthcare (ACHC)

54 out of 100

“Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information” scores 54 out of 100. The score uses 2 sources, and 6 linked companies.