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methotrexate prefilled syringe
methotrexate prefilled syringe is a Antimetabolite Small molecule drug developed by medac GmbH. It is currently in Phase 3 development for Rheumatoid arthritis, Psoriasis, Breast cancer.
Methotrexate is an antimetabolite that inhibits dihydrofolate reductase, disrupting DNA synthesis and cell division.
Methotrexate is a small molecule used in the treatment of conditions such as rheumatoid arthritis. It is administered via a prefilled syringe.
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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). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| 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 syringe |
|---|---|
| Sponsor | medac GmbH |
| Drug class | Antimetabolite |
| Target | Dihydrofolate reductase |
| Modality | Small molecule |
| Therapeutic area | Oncology, Autoimmune diseases |
| Phase | Phase 3 |
Mechanism of action
This results in the inhibition of rapidly dividing cells, such as cancer cells and activated immune cells. Methotrexate also has immunosuppressive properties, making it useful for treating autoimmune diseases.
Approved indications
- Rheumatoid arthritis
- Psoriasis
- Breast cancer
- Lung cancer
- Lymphoma
Common side effects
- Nausea
- Vomiting
- Diarrhea
- Fatigue
- Headache
Key clinical trials
- IL-7 and IL-7R Expression in RA Patients With Active vs. Inactive Disease Treated With DMARD or CIMZIA (PHASE4)
- Abatacept in Patients With Birdshot HLA A29 Uveitis (PHASE2)
- An Efficacy and Safety Study of Subcutaneous Tocilizumab in Combination With Methotrexate (MTX) and as Monotherapy Versus MTX in Participants With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Current Disease-Modifying Antirheumatic Drug (DMARD) Therapy (PHASE3)
- Evaluation of the Efficacy and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo and Adalimumab, in Subjects With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Have Active Disease (PHASE3)
- A Bioavailability Study of Methotrexate 25 mg Administered by Needle Injection and a Pre Filled Needle-free Device in Healthy Volunteers. (PHASE1)
- Study to Demonstrate Non-Inferior Efficacy and Safety of CinnoRA® Versus Humira® for Treatment of Active RA (PHASE3)
- Efficacy of Golimumab in Combination With Methotrexate (MTX) Versus MTX Monotherapy, in Improving Dactylitis, in MTX naïve Psoriatic Arthritis Patients (PHASE3)
- An Open-label Extension Study of Certolizumab Pegol in Chinese Patients With Rheumatoid Arthritis Who Enrolled in RA0044 (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 syringe CI brief — competitive landscape report
- methotrexate prefilled syringe updates RSS · CI watch RSS
- medac GmbH portfolio CI
Frequently asked questions about methotrexate prefilled syringe
What is methotrexate prefilled syringe?
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Related
- Drug class: All Antimetabolite drugs
- Target: All drugs targeting Dihydrofolate reductase
- Manufacturer: medac GmbH — full pipeline
- Therapeutic area: All drugs in Oncology, Autoimmune diseases
- Indication: Drugs for Rheumatoid arthritis
- Indication: Drugs for Psoriasis
- Indication: Drugs for Breast cancer
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing