Last reviewed 2026-06-02 · How we verify

PQR 309

PIQUR Therapeutics AG · Phase 1 active Small molecule ✓ Verified Jun 2026

PQR 309 is a Small molecule drug developed by PIQUR Therapeutics AG. It is currently in Phase 1 development. Also known as: PI3K/mTOR/AKT Inhibitor.

PQR 309 is a small molecule intervention that has been studied in a completed clinical trial for the treatment of advanced solid tumors. The trial, which was conducted by PIQUR Therapeutics AG, aimed to evaluate the safety and efficacy of oral PQR 309 in patients with advanced solid tumors.

Likelihood of approval

9.6% 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).

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	PQR 309
Also known as	PI3K/mTOR/AKT Inhibitor
Sponsor	PIQUR Therapeutics AG
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Study of Oral PQR309 in Patients With Advanced 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:

PQR 309 CI brief — competitive landscape report
PQR 309 updates RSS · CI watch RSS
PIQUR Therapeutics AG portfolio CI

Frequently asked questions about PQR 309

What is PQR 309?

PQR 309 is a Small molecule drug developed by PIQUR Therapeutics AG.

Who makes PQR 309?

PQR 309 is developed by PIQUR Therapeutics AG (see full PIQUR Therapeutics AG pipeline at /company/piqur-therapeutics-ag).

Is PQR 309 also known as anything else?

PQR 309 is also known as PI3K/mTOR/AKT Inhibitor.

What development phase is PQR 309 in?

PQR 309 is in Phase 1.

Manufacturer: PIQUR Therapeutics AG — full pipeline
Also known as: PI3K/mTOR/AKT Inhibitor

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