Last reviewed 2026-05-15 · How we verify

MTX + 5-FU sequential therapy

Japan Clinical Oncology Group · Phase 3 active Small molecule

MTX + 5-FU sequential therapy is a Antimetabolite combination chemotherapy Small molecule drug developed by Japan Clinical Oncology Group. It is currently in Phase 3 development for Gastric cancer (phase 3 evaluation), Colorectal cancer (potential indication).

MTX + 5-FU sequential therapy combines methotrexate and 5-fluorouracil administered in sequence to inhibit nucleotide synthesis and DNA replication in cancer cells.

MTX + 5-FU sequential therapy combines methotrexate and 5-fluorouracil administered in sequence to inhibit nucleotide synthesis and DNA replication in cancer cells. Used for Gastric cancer (phase 3 evaluation), Colorectal cancer (potential indication).

Likelihood of approval

61.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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.

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	MTX + 5-FU sequential therapy
Sponsor	Japan Clinical Oncology Group
Drug class	Antimetabolite combination chemotherapy
Target	Thymidylate synthase, dihydrofolate reductase
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

Methotrexate (MTX) is a folate antagonist that inhibits dihydrofolate reductase, blocking thymidylate synthase and nucleotide synthesis. When followed by 5-fluorouracil (5-FU), which is converted to active metabolites that inhibit thymidylate synthase and incorporate into RNA/DNA, the sequential administration may enhance cytotoxic effects through modulation of 5-FU metabolism and increased cellular uptake of 5-FU metabolites.

Approved indications

Gastric cancer (phase 3 evaluation)
Colorectal cancer (potential indication)

Common side effects

Myelosuppression
Mucositis
Diarrhea
Nausea/vomiting
Hand-foot syndrome
Hepatotoxicity

Key clinical trials

A Study of 5-FU Versus MTX+5-FU in Gastric Cancer With Peritoneal Metastasis (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:

MTX + 5-FU sequential therapy CI brief — competitive landscape report
MTX + 5-FU sequential therapy updates RSS · CI watch RSS
Japan Clinical Oncology Group portfolio CI

Frequently asked questions about MTX + 5-FU sequential therapy

What is MTX + 5-FU sequential therapy?

MTX + 5-FU sequential therapy is a Antimetabolite combination chemotherapy drug developed by Japan Clinical Oncology Group, indicated for Gastric cancer (phase 3 evaluation), Colorectal cancer (potential indication).

How does MTX + 5-FU sequential therapy work?

MTX + 5-FU sequential therapy combines methotrexate and 5-fluorouracil administered in sequence to inhibit nucleotide synthesis and DNA replication in cancer cells.

What is MTX + 5-FU sequential therapy used for?

MTX + 5-FU sequential therapy is indicated for Gastric cancer (phase 3 evaluation), Colorectal cancer (potential indication).

Who makes MTX + 5-FU sequential therapy?

MTX + 5-FU sequential therapy is developed by Japan Clinical Oncology Group (see full Japan Clinical Oncology Group pipeline at /company/japan-clinical-oncology-group).

What drug class is MTX + 5-FU sequential therapy in?

MTX + 5-FU sequential therapy belongs to the Antimetabolite combination chemotherapy class. See all Antimetabolite combination chemotherapy drugs at /class/antimetabolite-combination-chemotherapy.

What development phase is MTX + 5-FU sequential therapy in?

MTX + 5-FU sequential therapy is in Phase 3.

What are the side effects of MTX + 5-FU sequential therapy?

Common side effects of MTX + 5-FU sequential therapy include Myelosuppression, Mucositis, Diarrhea, Nausea/vomiting, Hand-foot syndrome, Hepatotoxicity.

What does MTX + 5-FU sequential therapy target?

MTX + 5-FU sequential therapy targets Thymidylate synthase, dihydrofolate reductase and is a Antimetabolite combination chemotherapy.

Drug class: All Antimetabolite combination chemotherapy drugs
Target: All drugs targeting Thymidylate synthase, dihydrofolate reductase
Manufacturer: Japan Clinical Oncology Group — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Gastric cancer (phase 3 evaluation)
Indication: Drugs for Colorectal cancer (potential indication)

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing