Last reviewed 2026-06-02 · How we verify

AROTINOLOL

Phase 3 active Small molecule ✓ Verified Jun 2026 Quality 19/100

AROTINOLOL is a arotinolol drug. It is currently in Phase 3 development.

Arotinolol works by blocking the action of certain enzymes in the body.

Arotinolol is a small molecule used in the treatment of essential hypertension, chronic kidney disease, nocturnal hypertension, and chronic kidney disease. It is administered as a hydrochloride and has been studied in clinical trials for its efficacy and safety in lowering morning blood pressure and heart rate.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% 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	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+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	AROTINOLOL
Drug class	arotinolol
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 3

Mechanism of action

Think of it like a key fitting into a lock. Arotinolol is a key that blocks the action of certain enzymes, which are like locks that control various bodily functions. By blocking these enzymes, arotinolol can help to slow down or stop certain processes in the body.

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:

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

Frequently asked questions about AROTINOLOL

What is AROTINOLOL?

AROTINOLOL is a arotinolol drug.

How does AROTINOLOL work?

Arotinolol works by blocking the action of certain enzymes in the body.

What drug class is AROTINOLOL in?

AROTINOLOL belongs to the arotinolol class. See all arotinolol drugs at /class/arotinolol.

What development phase is AROTINOLOL in?

AROTINOLOL is in Phase 3.

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

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