Last reviewed 2026-04-20 · How we verify

Methotrexate Oral Product

At a glance

Approved indications

No approved indications tracked.

Common side effects

• Diarrhoea
• Rash
• Nasopharyngitis
• Upper respiratory tract infection
• Hypertension
• Bronchitis
• Urinary tract infection
• Grades 3-5 Cardiac Disorders
• Headache
• Mycobacterium tuberculosis complex test positive
• Grades 3-5 GI Disorders
• Grades 3-5 General Disorders

Key clinical trials

• A Study to Test the Addition of the Drug Cabozantinib to Chemotherapy in Patients With Newly Diagnosed Osteosarcoma (PHASE2, PHASE3)
• A Study to Investigate LP-118, Ponatinib, Vincristine and Dexamethasone in Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LBL) (PHASE1, PHASE2)
• Phase 2 Study of Alisertib Therapy for Rhabdoid Tumors (PHASE2)
• CalPeg for Newly Diagnosed Acute Lymphoblastic Leukemia (ALL) (PHASE1)
• Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia (PHASE1)
• A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered Together (PHASE1)
• Pembrolizumab + Chemotherapy in Newly Diagnosed PCNSL (PHASE1)
• 05-001: Treatment of Acute Lymphoblastic Leukemia in Children (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Methotrexate Oral Product CI brief — competitive landscape report
• Methotrexate Oral Product updates RSS · CI watch RSS
• University of Chicago portfolio CI