Last reviewed 2026-05-31 · How we verify

Panolosetron

Bristol-Myers Squibb · Phase 1 active Small molecule ✓ Verified May 2026

Panolosetron is a Small molecule drug developed by Bristol-Myers Squibb. It is currently in Phase 1 development. Also known as: Aloxi®.

Panolosetron is a medication used to treat conditions related to solid tumors, as indicated by clinical trials on ClinicalTrials.gov. Its mechanism of action is not specified in the provided facts, but it is listed as an intervention in clinical trials alongside SAR302503 and a placebo.

Likelihood of approval

12.6% 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).
Big-pharma sponsor +3.0pp
Bristol-Myers Squibb is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

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	Panolosetron
Also known as	Aloxi®
Sponsor	Bristol-Myers Squibb
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Effect of SAR302503 on ECG Activity in Patients With Solid Tumors (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:

Panolosetron CI brief — competitive landscape report
Panolosetron updates RSS · CI watch RSS
Bristol-Myers Squibb portfolio CI

Frequently asked questions about Panolosetron

What is Panolosetron?

Panolosetron is a Small molecule drug developed by Bristol-Myers Squibb.

Who makes Panolosetron?

Panolosetron is developed by Bristol-Myers Squibb (see full Bristol-Myers Squibb pipeline at /company/bristol-myers-squibb).

Is Panolosetron also known as anything else?

Panolosetron is also known as Aloxi®.

What development phase is Panolosetron in?

Panolosetron is in Phase 1.

Manufacturer: Bristol-Myers Squibb — full pipeline
Therapeutic area: All drugs in Other
Also known as: Aloxi®

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