NDASUBCUTANEOUSSOLUTION
Approved
Jul 2014
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
20
Data completeness
6/8 — Strong
RASUVO (methotrexate) by Medexus Pharmaceuticals is reductase. First approved in 2014.
Drug data last refreshed 2h ago · AI intelligence enriched 4h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RASUVO is a subcutaneous solution formulation of methotrexate, a folate antagonist that inhibits dihydrofolate reductase and disrupts DNA synthesis in rapidly dividing cells. It is approved for multiple indications including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and psoriasis, though its exact mechanism in autoimmune conditions remains unknown. The drug targets actively proliferating tissues and is particularly effective against malignant cells and immune-driven inflammation.
$21MPart D
LOE Approaching2.7 years to LOEWith LOE approaching in 2029 and modest Medicare claims (~29K annually), the RASUVO brand team is focused on defending market position against generic methotrexate competitors rather than expanding market share.
Mechanism of Action
reductase. Dihydrofolates must be reduced to tetrahydrofolates by this enzyme before they can be utilized as carriers of one-carbon groups in the synthesis of purine nucleotides and thymidylate. Therefore, methotrexate interferes with DNA synthesis, repair, and cellular replication. Actively…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Natrunix in Combination With Methotrexate for Rheumatoid Arthritis Treatment
Started Jul 2026
108 enrolled
Rheumatoid Arthritis
A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered Together
Started Mar 2026
48 enrolled
Healthy Volunteers
A Study to Assess the Safety and Efficacy of Different Doses of ELV001 to Treat Active Rheumatoid Arthritis in Patients With an Inadequate Response to Methotrexate and Tumor Necrosis Factor Inhibition (START SYNERGY)
Started Feb 2026
180 enrolled
Active Rheumatoid Arthritis
A Double-blind, Randomized Controlled Trial to Investigate the Efficacy, Safety, and Pharmacokinetics of Pegloticase Administration Via Subcutaneous and Intravenous Routes Both With Methotrexate in Participants With Uncontrolled Gout
Started Feb 2026
270 enrolled
Uncontrolled Gout
A Multicenter, Prospective Clinical Trial With a Concurrent Control Evaluating Methotrexate Combined With Rituximab,Sintilimab and Pirtobrutinib vs. Investigator-Selected Standard of Care in Treatment-Naive PCNSL
Started Dec 2025
77 enrolled
PCNSLPrimary Central Nervous System Lymphoma
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.