Last reviewed 2026-05-29 · How we verify

Stresson (BUNITROLOL)

Phase 2 active Small molecule ✓ Verified May 2026

Stresson (generic name: BUNITROLOL) is a bunitrolol drug. It is currently in Phase 2 development.

Bunitrolol is a beta-adrenergic receptor blocker that works by blocking the effects of the hormone epinephrine, also known as adrenaline.

Stresson is a small molecule intervention used in clinical trials for Gastric Cancer and Pancreatic Cancer. It was studied in a prospective, randomized trial (NCT00558155) as part of immunostimulating nutrition to reduce infectious complications after upper gastrointestinal surgery.

Likelihood of approval

13.3% 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).
Cardiovascular Phase 3 risk -2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.

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	BUNITROLOL
Drug class	bunitrolol
Modality	Small molecule
Therapeutic area	Cardiovascular
Phase	Phase 2

Mechanism of action

Imagine your body's 'fight or flight' response, which is triggered by the hormone epinephrine. Bunitrolol helps to slow down this response by blocking the action of epinephrine on the heart and blood vessels, which can help to reduce blood pressure and heart rate.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Title: The Impact of Immunostimulating Nutrition on Infectious Complications After Upper Gastrointestinal Surgery - A Prospective, Randomized, Clinical Trial. (Phase 4)

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:

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

Frequently asked questions about Stresson

What is Stresson?

Stresson (BUNITROLOL) is a bunitrolol drug.

How does Stresson work?

Bunitrolol is a beta-adrenergic receptor blocker that works by blocking the effects of the hormone epinephrine, also known as adrenaline.

What is the generic name of Stresson?

BUNITROLOL is the generic (nonproprietary) name of Stresson.

What drug class is Stresson in?

Stresson belongs to the bunitrolol class. See all bunitrolol drugs at /class/bunitrolol.

What development phase is Stresson in?

Stresson is in Phase 2.

Drug class: All bunitrolol drugs
Therapeutic area: All drugs in Cardiovascular

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