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Methotrexate,Calcium folinate
Methotrexate,Calcium folinate is a Small molecule drug developed by Tianjin Medical University Cancer Institute and Hospital. It is currently in Phase 1 development.
Methotrexate is a small molecule used in the treatment of various types of leukemia, including Acute Lymphoblastic Leukemia, as indicated by ClinicalTrials.gov. Calcium folinate, also known as calcium levofolinate, is a compound with an unknown mechanism of action, as stated by ChEMBL.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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,Calcium folinate |
|---|---|
| Sponsor | Tianjin Medical University Cancer Institute and Hospital |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
- Infections and infestations - Other, specify
- Neutrophil count decreased
- Alanine aminotransferase increased
- Febrile neutropenia
- Hyperglycemia
- Platelet count decreased
- Hypocalcemia
- White blood cell decreased
- Hyponatremia
- Peripheral sensory neuropathy
- Anemia
- Hypokalemia
Key clinical trials
- Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia (PHASE2)
- A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia (PHASE3)
- Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia (PHASE2)
- A Study of the Efficacy and Safety of Lisocabtagene Maraleucel (Liso-cel) as First-Line Therapy in Adults With Transplant-Ineligible Primary Central Nervous System Lymphoma (PHASE2)
- Venetoclax Basket Trial for High Risk Hematologic Malignancies (PHASE1)
- A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia (PHASE2)
- Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy (PHASE3)
- A Study to Find the Highest Dose of Imetelstat in Combination With Fludarabine and Cytarabine for Patients With AML, MDS or JMML That Has Come Back or Does Not Respond to Therapy (PHASE1)
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,Calcium folinate CI brief — competitive landscape report
- Methotrexate,Calcium folinate updates RSS · CI watch RSS
- Tianjin Medical University Cancer Institute and Hospital portfolio CI
Frequently asked questions about Methotrexate,Calcium folinate
What is Methotrexate,Calcium folinate?
Who makes Methotrexate,Calcium folinate?
What development phase is Methotrexate,Calcium folinate in?
What are the side effects of Methotrexate,Calcium folinate?
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing