Last reviewed 2026-04-20 · How we verify

GSK 5733584

QuantumLeap Healthcare Collaborative · Phase 2 active Small molecule Quality 0/100

GSK 5733584 is a Small molecule drug developed by QuantumLeap Healthcare Collaborative. It is currently in Phase 2 development.

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	GSK 5733584
Sponsor	QuantumLeap Healthcare Collaborative
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (PHASE2)

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:

GSK 5733584 CI brief — competitive landscape report
GSK 5733584 updates RSS · CI watch RSS
QuantumLeap Healthcare Collaborative portfolio CI

Frequently asked questions about GSK 5733584

What is GSK 5733584?

GSK 5733584 is a Small molecule drug developed by QuantumLeap Healthcare Collaborative.

Who makes GSK 5733584?

GSK 5733584 is developed by QuantumLeap Healthcare Collaborative (see full QuantumLeap Healthcare Collaborative pipeline at /company/quantumleap-healthcare-collaborative).

What development phase is GSK 5733584 in?

GSK 5733584 is in Phase 2.

Manufacturer: QuantumLeap Healthcare Collaborative — full pipeline

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