Last reviewed 2026-05-18 · How we verify

Cytokine-based Biologic Agent IRX-2

City of Hope Medical Center · Phase 1 active Biologic Quality 25/100

Cytokine-based Biologic Agent IRX-2 is a Cytokine-based immunotherapy Biologic drug developed by City of Hope Medical Center. It is currently in Phase 1 development. Also known as: IRX-2.

A mixture of human cytokines that may modulate immune responses through multiple cytokine pathways.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	Cytokine-based Biologic Agent IRX-2
Also known as	IRX-2
Sponsor	City of Hope Medical Center
Drug class	Cytokine-based immunotherapy
Modality	Biologic
Phase	Phase 1

Mechanism of action

IRX-2 is composed of multiple naturally-derived human cytokines that may work together to stimulate immune system activity. The specific cytokine composition and precise mechanisms of action have not been fully characterized in available public information.

Approved indications

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Cytokine-based Biologic Agent IRX-2 CI brief — competitive landscape report
Cytokine-based Biologic Agent IRX-2 updates RSS · CI watch RSS
City of Hope Medical Center portfolio CI

Frequently asked questions about Cytokine-based Biologic Agent IRX-2

What is Cytokine-based Biologic Agent IRX-2?

Cytokine-based Biologic Agent IRX-2 is a Cytokine-based immunotherapy drug developed by City of Hope Medical Center.

How does Cytokine-based Biologic Agent IRX-2 work?

A mixture of human cytokines that may modulate immune responses through multiple cytokine pathways.

Who makes Cytokine-based Biologic Agent IRX-2?

Cytokine-based Biologic Agent IRX-2 is developed by City of Hope Medical Center (see full City of Hope Medical Center pipeline at /company/city-of-hope-medical-center).

Is Cytokine-based Biologic Agent IRX-2 also known as anything else?

Cytokine-based Biologic Agent IRX-2 is also known as IRX-2.

What drug class is Cytokine-based Biologic Agent IRX-2 in?

Cytokine-based Biologic Agent IRX-2 belongs to the Cytokine-based immunotherapy class. See all Cytokine-based immunotherapy drugs at /class/cytokine-based-immunotherapy.

What development phase is Cytokine-based Biologic Agent IRX-2 in?

Cytokine-based Biologic Agent IRX-2 is in Phase 1.

Drug class: All Cytokine-based immunotherapy drugs
Manufacturer: City of Hope Medical Center — full pipeline
Also known as: IRX-2

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