ClinicalTrials.gg
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

In context

Depressive Disorder, Major

3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.

Browse Depressive Disorder, Major studies →

Lead sponsor

Relmada Therapeutics, Inc. is the lead sponsor of 11 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 health conditions which in the opinion of the Investigator would negatively impact the safety of the participant.
  • History of prolongation.
  • History of allergy or to methadone or related drugs.
  • Pregnant or planning to become pregnant.
  • Breast-feeding or planning to breast-feed.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Access details

Study type
Expanded access
Access type
Individual patients

Available treatment

  • REL-1017 tablet

    Also known as: esmethadone

06

Where to request access

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

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.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion