Last reviewed 2026-04-20 · How we verify

Balarsen (ARSTHINOL)

Phase 2 active Small molecule

Balarsen (generic name: ARSTHINOL) is a arsthinol drug. It is currently in Phase 2 development.

ARSTHINOL works by interacting with a specific biological pathway to produce its therapeutic effect.

ARSTHINOL, also known as Balarsen, is a small molecule drug in the arsthinol class. Its exact target and mechanism of action are unknown, but it is believed to work by modulating a specific biological pathway. ARSTHINOL is not FDA-approved for any indications, and its commercial status, including patent and generic availability, is unclear. Further research is needed to determine its safety and efficacy. As a result, key safety considerations and approved indications are currently unavailable.

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	ARSTHINOL
Drug class	arsthinol
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells are like a orchestra, and each cell plays a specific note to create a symphony. ARSTHINOL is like a conductor that helps the cells play their notes in harmony, leading to a therapeutic effect. However, the exact way it conducts the cells is still unknown.

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:

Balarsen CI brief — competitive landscape report
Balarsen updates RSS · CI watch RSS

Frequently asked questions about Balarsen

What is Balarsen?

Balarsen (ARSTHINOL) is a arsthinol drug.

How does Balarsen work?

ARSTHINOL works by interacting with a specific biological pathway to produce its therapeutic effect.

What is the generic name of Balarsen?

ARSTHINOL is the generic (nonproprietary) name of Balarsen.

What drug class is Balarsen in?

Balarsen belongs to the arsthinol class. See all arsthinol drugs at /class/arsthinol.

What development phase is Balarsen in?

Balarsen is in Phase 2.

Drug class: All arsthinol drugs
Therapeutic area: All drugs in Other

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