NCT06257420 is a clinical trial of Rapamycin in Myalgic Encephalomyelitis, sponsored by Simmaron Research Inc..

Who is sponsoring NCT06257420?

NCT06257420 is sponsored by Simmaron Research Inc..

What drugs are being tested in NCT06257420?

Interventions in NCT06257420: Rapamycin.

What condition does NCT06257420 study?

NCT06257420 studies Myalgic Encephalomyelitis, Long-COVID.

Is NCT06257420 still recruiting?

NCT06257420 is currently enrolling by invitation. Last updated 5 November 2024.

Last reviewed 2024-11-05 · How we verify

NCT06257420

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Low Dose Rapamycin in ME/CFS, Long-COVID, and Other Infection Associated Chronic Conditions

ENROLLING BY INVITATION Last updated 5 November 2024

What this trial tests

trial testing Rapamycin in Myalgic Encephalomyelitis in 150 participants. Enrolling by invitation.

Timeline

11 December 2023

Primary endpoint
11 December 2025

11 June 2026

Quick facts

Lead sponsor	Simmaron Research Inc.
Status	ENROLLING BY INVITATION
Study type	OBSERVATIONAL
Enrollment	150
Start date	11 December 2023
Primary completion	11 December 2025
Estimated completion	11 June 2026
Sites	5 locations across United States

Drugs / interventions tested

Rapamycin — full drug profile →

Conditions studied

Myalgic Encephalomyelitis — all drugs for Myalgic Encephalomyelitis →
Long-COVID — all drugs for Long-COVID →

Sponsor

Simmaron Research Inc.

Who can join

Adults 18 to 65, any sex, with Myalgic Encephalomyelitis or Long-COVID. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this observational study is to assess the clinical response and the effect of autophagy function in patients before, during and throughout oral low dose sirolimus (rapamycin) therapy. The main questions this study aims to answer are: * Does rapamycin reduce the overall symptom burden in this patient population and does it improve the quality of life? * Does rapamycin change mTOR driven autophagy deficits observed in a subset of patients? Participants will be asked to complete a series of questionnaires and quality of life instruments before starting rapamycin therapy prescribed by their physician and throughout their course of treatment. Study blood samples will be collected before starting therapy and throughout the course of treatment to assess serological markers of autophagy function.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Advocating the role of trained immunity in the pathogenesis of ME/CFS: a mini review.
Humer B, Dik WA, Versnel MA. · · 2025 · cited 7× · PMID 40201181 · DOI 10.3389/fimmu.2025.1483764
Inactivation of ATG13 stimulates chronic demyelinating pathologies in muscle-serving nerves and spinal cord.
Drosen ME, Bulbule S, Gottschalk G, Peterson D, et al · · 2025 · cited 6× · PMID 39777574 · DOI 10.1007/s12026-024-09557-7
Low-dose rapamycin alleviates clinical symptoms of fatigue and PEM in ME/CFS patients via improvement of autophagy: a pilot study.
Ruan BT, Bulbule S, Gile B, Reyes A, et al · · 2025 · cited 4× · PMID 41121328 · DOI 10.1186/s12967-025-07213-8
Experimental and clinical tests of FDA-approved kinase inhibitors for the treatment of neurological disorders (update 2024).
Aliashrafzadeh H, Liu D, De Alba S, Akbar I, et al · · 2025 · PMID 40708570 · DOI 10.37349/eds.2025.1008116

Verify or expand the search:

Other trials of Rapamycin

Trials testing the same drug.

NCT06743503 — UB-VV400 in Combination With Rapamycin in Relapsed or Refractory B-cell Malignancies · Phase 1 · recruiting
NCT06550271 — The Bioavailability of Compounded and Generic Rapamycin in Normative Aging Individuals · completed
NCT05342519 — Daily Topical Rapamycin for Vitiligo · Phase 2 · active not recruiting
NCT04736589 — Inetetamab Plus Rapamycin and Chemotherapy for HER2+ Metastatic Breast Cancer With Abnormal Activation of PAM Pathway · Phase 3 · not yet recruiting
NCT04488601 — Participatory Evaluation (of) Aging (With) Rapamycin (for) Longevity Study · Phase 2 · completed

Other recruiting trials for Myalgic Encephalomyelitis

Currently open trials in the same condition.

NCT05741112 — The Long COVID-19 Wearable Device Study · NA · recruiting
NCT05236465 — A 3-day Course for CFS/ME · NA · recruiting
NCT05167227 — Does a Technology Enabled Multi-disciplinary Team-based Care Model for the Management of Long COVID and Other Fatiguing · NA · active not recruiting
NCT04542161 — Assessment of N-Acetylcysteine as Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06257420 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Simmaron Research Inc.
Last refreshed: 5 November 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06257420.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing