Last reviewed 2026-04-23 · How we verify

neoadjuvant chemotherapyI

Sun Yat-sen University · Phase 3 active Small molecule

neoadjuvant chemotherapyI is a Chemotherapy Small molecule drug developed by Sun Yat-sen University. It is currently in Phase 3 development for Breast cancer, Colorectal cancer, Esophageal cancer. Also known as: mFOLFOXIR.

Neoadjuvant chemotherapy involves administering chemotherapy before the main treatment to reduce tumor size and make it easier to remove.

Neoadjuvant chemotherapy involves administering chemotherapy before the main treatment to reduce tumor size and make it easier to remove. Used for Breast cancer, Colorectal cancer, Esophageal cancer.

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	neoadjuvant chemotherapyI
Also known as	mFOLFOXIR
Sponsor	Sun Yat-sen University
Drug class	Chemotherapy
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

This approach allows for more effective surgery and potentially reduces the risk of cancer recurrence. The specific chemotherapy agents used may vary depending on the type and stage of cancer.

Approved indications

Breast cancer
Colorectal cancer
Esophageal cancer
Gastric cancer
Head and neck cancer
Lung cancer
Pancreatic cancer
Soft tissue sarcoma
Stomach cancer
Thymus cancer

Common side effects

Nausea
Vomiting
Fatigue
Hair loss
Diarrhea
Anemia
Infection
Neutropenia
Thrombocytopenia
Anorexia

Key clinical trials

Neoadjuvant FOLFOXIRI Versus Immediate Surgery for Stage II and III Colon Cancers (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:

neoadjuvant chemotherapyI CI brief — competitive landscape report
neoadjuvant chemotherapyI updates RSS · CI watch RSS
Sun Yat-sen University portfolio CI

Frequently asked questions about neoadjuvant chemotherapyI

What is neoadjuvant chemotherapyI?

neoadjuvant chemotherapyI is a Chemotherapy drug developed by Sun Yat-sen University, indicated for Breast cancer, Colorectal cancer, Esophageal cancer.

How does neoadjuvant chemotherapyI work?

Neoadjuvant chemotherapy involves administering chemotherapy before the main treatment to reduce tumor size and make it easier to remove.

What is neoadjuvant chemotherapyI used for?

neoadjuvant chemotherapyI is indicated for Breast cancer, Colorectal cancer, Esophageal cancer, Gastric cancer, Head and neck cancer.

Who makes neoadjuvant chemotherapyI?

neoadjuvant chemotherapyI is developed by Sun Yat-sen University (see full Sun Yat-sen University pipeline at /company/sun-yat-sen-university).

Is neoadjuvant chemotherapyI also known as anything else?

neoadjuvant chemotherapyI is also known as mFOLFOXIR.

What drug class is neoadjuvant chemotherapyI in?

neoadjuvant chemotherapyI belongs to the Chemotherapy class. See all Chemotherapy drugs at /class/chemotherapy.

What development phase is neoadjuvant chemotherapyI in?

neoadjuvant chemotherapyI is in Phase 3.

What are the side effects of neoadjuvant chemotherapyI?

Common side effects of neoadjuvant chemotherapyI include Nausea, Vomiting, Fatigue, Hair loss, Diarrhea, Anemia.

Drug class: All Chemotherapy drugs
Manufacturer: Sun Yat-sen University — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Breast cancer
Indication: Drugs for Colorectal cancer
Indication: Drugs for Esophageal cancer
Also known as: mFOLFOXIR

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