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High-dose intravenous methotrexate — Competitive Intelligence Brief

High-dose intravenous methotrexate (High-dose intravenous methotrexate) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Antimetabolite; folate antagonist. Area: Oncology.

phase 3 Antimetabolite; folate antagonist Dihydrofolate reductase (DHFR) Oncology Small molecule Live · refreshed every 30 min

Target snapshot

High-dose intravenous methotrexate (High-dose intravenous methotrexate) — Chonnam National University Hospital. High-dose intravenous methotrexate inhibits dihydrofolate reductase, blocking DNA synthesis and cell division in rapidly proliferating cells.

Comparator set (6 drugs)

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DrugGenericSponsorPhaseClassTargetApproval / PDUFA
High-dose intravenous methotrexate TARGET High-dose intravenous methotrexate Chonnam National University Hospital phase 3 Antimetabolite; folate antagonist Dihydrofolate reductase (DHFR)
Methotrexate (MTX) Methotrexate (MTX) Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh marketed Antimetabolite; folate antagonist Dihydrofolate reductase (DHFR)
Intrathecal Methotrexate Intrathecal Methotrexate Sun Yat-sen University marketed Antimetabolite; folate antagonist Dihydrofolate reductase (DHFR)
Methotrexate (tapering dose) Methotrexate (tapering dose) Hoffmann-La Roche marketed Antimetabolite / Folate antagonist Dihydrofolate reductase (DHFR)
MTX therapy MTX therapy NYU Langone Health marketed Folate antagonist / Antimetabolite Dihydrofolate reductase (DHFR)
Placebo Methotrexate Placebo Methotrexate AbbVie marketed Folate antagonist / Antimetabolite Dihydrofolate reductase (DHFR)
MTX MTX South China Children's Leukemia Group marketed Antimetabolite; folate antagonist Dihydrofolate reductase (DHFR)

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Antimetabolite; folate antagonist class)

  1. Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh · 1 drug in this class
  2. Case Comprehensive Cancer Center · 1 drug in this class
  3. Chonnam National University Hospital · 1 drug in this class
  4. South China Children's Leukemia Group · 1 drug in this class
  5. Sun Yat-sen University · 1 drug in this class
  6. University Hospital, Montpellier · 1 drug in this class

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Cite this brief

Drug Landscape (2026). High-dose intravenous methotrexate — Competitive Intelligence Brief. https://druglandscape.com/ci/high-dose-intravenous-methotrexate. Accessed 2026-05-16.

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