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No longer availableNCT06009003Updated Aug 12, 2026

Individual Patient Esmethadone (REL-1017) Expanded Access Program

An expanded access record providing REL-1017 in Major Depressive Disorder and Depression, sponsored by Relmada Therapeutics, Inc.. No longer available. Per ClinicalTrials.gov, last updated 2026-08-12.

Sponsored by Relmada Therapeutics, Inc. · Expanded access

Study type
Expanded access
Access type
Individual patients
Sex
All
01

Study summary

To provide expanded access of esmethadone (REL-1017) to patients with a serious or immediately life-threatening disease or condition that may potentially benefit from esmethadone (REL-1017) who do not have access to other effective therapy and are not eligible for other clinical trials with esmethadone (REL-1017).

Read the detailed description

The Expanded Access Program (EAP) is intended to provide pre-approval access to esmethadone (REL-1017) for eligible patients who suffer from a serious or immediately life-threatening disease or condition that may potentially benefit from esmethadone (REL-1017) as determined by the treating physician and have no satisfactory treatment options. This program is open in the United States and operates under the Individual Patient (also referred to as Single Patient) IND expanded access route in which the patient's treating physician serves as the sponsor. Expanded access requests must be from the patient's treating physicians and submitted according to the Relmada EAP policy at https://www.relmada.com/our-portfolio/eap.

02

Conditions studied

  • Major Depressive Disorder
  • Depression

Keywords

  • REL-1017
  • esmethadone
  • Relmada
  • antidepressant
  • NMDA receptor antagonist
  • Depression
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All

Inclusion criteria

  • Patients who may potentially benefit from treatment with esmethadone (REL-1017) as determined by the treating physician.
  • Have undergone appropriate standard treatments without success and in the opinion of the treating physician no comparable or satisfactory alternative treatment is available to treat the disease or condition.
  • Are ineligible or unable to participate in any ongoing clinical study of the investigational product.
  • Condition for which, in the opinion of the treating physician, there is sufficient evidence of a potential benefit from the use of the investigational product, and that potential benefit outweighs the known or anticipated risks.

Exclusion criteria

Exclusion Criteria:

  • History or presence of clinically significant health conditions which in the opinion of the Investigator would negatively impact the safety of the participant.
  • History of QTc prolongation.
  • History of allergy or hypersensitivity to methadone or related drugs.
  • Pregnant or planning to become pregnant.
  • Breast-feeding or planning to breast-feed.
04

Access details

Study type
Expanded access
Access type
Individual patients

Available treatment

  • DrugREL-1017

    REL-1017 tablet

    Also known as: esmethadone

05

Where to request access

No study locations are listed for this record.

06

Registry details

Key details

Study ID
NCT06009003
Lead sponsor
Relmada Therapeutics, Inc.
Collaborators
Sponsor-Investigator
Responsible party
Sponsor
First posted
Aug 24, 2023
Last update
Aug 12, 2026

Study contacts

Marco Pappagallo, MD
study director · Relmada Therapeutics
View the source record on ClinicalTrials.gov ↗

Requesting access

Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.

No contact was published for this record. The registry link below has the sponsor’s details.

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