Last reviewed 2026-06-02 · How we verify

Indocyaine Green

Corewell Health West · Phase 2 active Small molecule ✓ Verified Jun 2026

Indocyaine Green is a Small molecule drug developed by Corewell Health West. It is currently in Phase 2 development. Also known as: ICG.

Indocyanine Green is a small molecule used in medical imaging, specifically in the evaluation of Heidelberg Engineering SPECTRALIS with OCT Angiography Module for conditions such as Retinal Vascular and Normal Eyes. It is also used in conjunction with other imaging techniques like Fluorescein Angiography and Color Fundus Photography for conditions including Wound Healing and Lower Extremity Amputation.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	Indocyaine Green
Also known as	ICG
Sponsor	Corewell Health West
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

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:

Indocyaine Green CI brief — competitive landscape report
Indocyaine Green updates RSS · CI watch RSS
Corewell Health West portfolio CI

Frequently asked questions about Indocyaine Green

What is Indocyaine Green?

Indocyaine Green is a Small molecule drug developed by Corewell Health West.

Who makes Indocyaine Green?

Indocyaine Green is developed by Corewell Health West (see full Corewell Health West pipeline at /company/corewell-health-west).

Is Indocyaine Green also known as anything else?

Indocyaine Green is also known as ICG.

What development phase is Indocyaine Green in?

Indocyaine Green is in Phase 2.

Manufacturer: Corewell Health West — full pipeline
Also known as: ICG

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