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Compound · clinical trials

Methotrexate Sodium clinical trials

Also listed in trial records as Trexall, Xatmep
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 3 trials in our Canada, Mexico and Brazil registers that name Methotrexate Sodium as an intervention. Synced 28 Sep 2026
3Current trials
1Recruiting now
3Lead sponsors
3Country registers
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 โ€” Top 14 finalist
Compiled from ClinicalTrials.gov registry records ยท Last verified ยท Editorial standards
At a glance

Methotrexate Sodium is named as an intervention in 3 current clinical trials in our Canada, Mexico and Brazil registers. 1 is recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Emory University (1). The most-studied condition is Sickle Cell Disease.

Where Methotrexate Sodium is approved

All regulators →

Of the three regulators tracked here, the first to approve Methotrexate Sodium was the US, on 7 Dec 1953. It is approved in 3 of the 3 regulators tracked here.

USUnited States (FDA)
7 Dec 1953
Methotrexate Sodium
NDA008085 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
18 Aug 2016
Nordimet
EMA product page
First centralised authorisation
CACanada (Health Canada)
11 May 1994
Abitrexate
Notice of Compliance 5398
First new-drug NOC

From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.

Methotrexate Sodium patents and exclusivity

Expiry tracker →

Protections still running for marketed products containing Methotrexate Sodium, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.

US FDA Orange Book Methotrexate Sodium, Methotrexate Sodium Preservative Free, Jylamvo
  • 11 listed patents; the last listed expires 28 Oct 2035 (US 11129833).
See the Orange Book listing for NDA 011719
Patents and exclusivities above are pooled across 4 applications for this substance.

Reproduced from the FDA Orange Book and Purple Book (checked 28 Sep 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.

Trials by status

  • Recruiting133%
  • Active, closed267%

Trials by phase

  • Phase 2267%
  • Phase 4133%
01

Clinical trials of Methotrexate Sodium

3 trials
StudyPhaseStatusLead sponsorRegisters
Use of Letrozole for Ectopic Pregnancy
NCT06354439 · ClinicalTrials.gov ↗ · Ectopic Pregnancy
Phase 4 Recruiting Hospital de Clinicas de Porto Alegre Brazil
Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia
NCT02143414 · Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
Phase 2 Active, closed National Cancer Institute (NCI) Mexico
Early Human Leukocyte Antigen (HLA) Matched Sibling Hematopoietic Stem Cell Transplantation
NCT04018937 · ClinicalTrials.gov ↗ · Sickle Cell Disease
Phase 2 Active, closed Emory University Canada

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Conditions studied with Methotrexate Sodium

6 conditions
Sickle Cell Disease1Acute Lymphoblastic Leukemia1B Acute Lymphoblastic Leukemia1B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL11Recurrent Acute Lymphoblastic Leukemia1Ectopic Pregnancy1
03

Sponsors

lead sponsor per trial
Lead sponsorTrials
Emory University1
National Cancer Institute (NCI)1
Hospital de Clinicas de Porto Alegre1
04

By country register

RegisterTrialsRecruiting
Clinical trials in Canada10
Clinical trials in Mexico10
Clinical trials in Brazil11

A trial with sites in more than one country appears in each of those registers.

05

Related compounds

06

Questions about Methotrexate Sodium trials

How many clinical trials are testing Methotrexate Sodium?

3 current trials in our Canada, Mexico and Brazil registers name Methotrexate Sodium as a drug or biological intervention, as of the registry sync on 28 September 2026. Completed and withdrawn studies are not counted.

Are Methotrexate Sodium trials recruiting patients?

Yes. 1 of the 3 trials is recruiting: 1 with sites in Brazil. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Methotrexate Sodium clinical trials?

Emory University (1), National Cancer Institute (NCI) (1) and Hospital de Clinicas de Porto Alegre (1). The number in brackets is how many trials each organisation leads.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Methotrexate Sodium works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records โ€” it is not written from memory, and nothing here describes how Methotrexate Sodium works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Methotrexate Sodium (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 28 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician โ€” our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us โ€” we correct promptly and log it.