Last reviewed 2026-04-19 · How we verify

GD2-SADA:177Lu-DOTA Complex

Y-mAbs Therapeutics · Phase 1 active Small molecule

GD2-SADA:177Lu-DOTA Complex is a Small molecule drug developed by Y-mAbs Therapeutics. It is currently in Phase 1 development. Also known as: two-step radioimmunotherapy.

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	GD2-SADA:177Lu-DOTA Complex
Also known as	two-step radioimmunotherapy
Sponsor	Y-mAbs Therapeutics
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2 (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:

GD2-SADA:177Lu-DOTA Complex CI brief — competitive landscape report
GD2-SADA:177Lu-DOTA Complex updates RSS · CI watch RSS
Y-mAbs Therapeutics portfolio CI

Frequently asked questions about GD2-SADA:177Lu-DOTA Complex

What is GD2-SADA:177Lu-DOTA Complex?

GD2-SADA:177Lu-DOTA Complex is a Small molecule drug developed by Y-mAbs Therapeutics.

Who makes GD2-SADA:177Lu-DOTA Complex?

GD2-SADA:177Lu-DOTA Complex is developed by Y-mAbs Therapeutics (see full Y-mAbs Therapeutics pipeline at /company/y-mabs-therapeutics).

Is GD2-SADA:177Lu-DOTA Complex also known as anything else?

GD2-SADA:177Lu-DOTA Complex is also known as two-step radioimmunotherapy.

What development phase is GD2-SADA:177Lu-DOTA Complex in?

GD2-SADA:177Lu-DOTA Complex is in Phase 1.

Manufacturer: Y-mAbs Therapeutics — full pipeline
Also known as: two-step radioimmunotherapy

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