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methotrexate prefilled pen
methotrexate prefilled pen is a antimetabolite/antifolate DMARD Small molecule drug developed by medac GmbH. It is currently in Phase 3 development.
Methotrexate inhibits dihydrofolate reductase, blocking folate metabolism and thereby suppressing DNA synthesis and cell proliferation.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | methotrexate prefilled pen |
|---|---|
| Sponsor | medac GmbH |
| Drug class | antimetabolite/antifolate DMARD |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
Methotrexate competitively inhibits dihydrofolate reductase, preventing the conversion of dihydrofolate to tetrahydrofolate. This depletes cellular folate pools necessary for purine and thymidylate synthesis, ultimately inhibiting DNA replication and cell division, particularly affecting rapidly dividing cells including immune cells.
Approved indications
Common side effects
Key clinical trials
- Preventing Structural Damage in Early Psoriatic Arthritis (PHASE4)
- Efficacy and Safety of Methotrexate Versus Placebo in Adults With Atopic Dermatitis. (PHASE3)
- Human Factors Study of Methotrexate Prefilled Pen (50 mg/mL) in Patients With Juvenile Idiopathic Arthritis (EARLY_PHASE1)
- Bioavailability in Patient With Psoriasis: Metoject Prefilled Pen (PHASE1)
- Evaluation of Patient Performance Using the Metoject Device for Subcutaneous Injection in Rheumatoid Arthritis (RA)Patient (PHASE1)
- Preference Methotrexate (MTX) Pre-filled Syringe Versus Pre-filled Pen in Rheumatoid Arthritis (RA) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- methotrexate prefilled pen CI brief — competitive landscape report
- methotrexate prefilled pen updates RSS · CI watch RSS
- medac GmbH portfolio CI
Frequently asked questions about methotrexate prefilled pen
What is methotrexate prefilled pen?
How does methotrexate prefilled pen work?
Who makes methotrexate prefilled pen?
What drug class is methotrexate prefilled pen in?
What development phase is methotrexate prefilled pen in?
Related
- Drug class: All antimetabolite/antifolate DMARD drugs
- Manufacturer: medac GmbH — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing