Last reviewed 2026-05-19 · How we verify

[177Lu]Lu-SN201

Spago Nanomedical AB · Phase 1 active Small molecule ✓ Verified May 2026

[177Lu]Lu-SN201 is a Small molecule drug developed by Spago Nanomedical AB. It is currently in Phase 1 development. Also known as: Tumorad.

[177Lu]Lu-SN201 is a binding agent that targets carbonic anhydrase 9. It is a carbonic anhydrase IX binding agent, specifically the 177Lu-labeled version of CG250.

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	[177Lu]Lu-SN201
Also known as	Tumorad
Sponsor	Spago Nanomedical AB
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

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:

[177Lu]Lu-SN201 CI brief — competitive landscape report
[177Lu]Lu-SN201 updates RSS · CI watch RSS
Spago Nanomedical AB portfolio CI

Frequently asked questions about [177Lu]Lu-SN201

What is [177Lu]Lu-SN201?

[177Lu]Lu-SN201 is a Small molecule drug developed by Spago Nanomedical AB.

Who makes [177Lu]Lu-SN201?

[177Lu]Lu-SN201 is developed by Spago Nanomedical AB (see full Spago Nanomedical AB pipeline at /company/spago-nanomedical-ab).

Is [177Lu]Lu-SN201 also known as anything else?

[177Lu]Lu-SN201 is also known as Tumorad.

What development phase is [177Lu]Lu-SN201 in?

[177Lu]Lu-SN201 is in Phase 1.

Manufacturer: Spago Nanomedical AB — full pipeline
Also known as: Tumorad

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