Last reviewed 2026-05-18 · How we verify

KPL-914

Kiniksa Pharmaceuticals (UK), Ltd. · Phase 2 active Small molecule Quality 10/100

KPL-914 is a Small molecule drug developed by Kiniksa Pharmaceuticals (UK), Ltd.. It is currently in Phase 2 development. Also known as: rilonacept.

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	KPL-914
Also known as	rilonacept
Sponsor	Kiniksa Pharmaceuticals (UK), Ltd.
Modality	Small molecule
Phase	Phase 2

Approved indications

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:

KPL-914 CI brief — competitive landscape report
KPL-914 updates RSS · CI watch RSS
Kiniksa Pharmaceuticals (UK), Ltd. portfolio CI

Frequently asked questions about KPL-914

What is KPL-914?

KPL-914 is a Small molecule drug developed by Kiniksa Pharmaceuticals (UK), Ltd..

Who makes KPL-914?

KPL-914 is developed by Kiniksa Pharmaceuticals (UK), Ltd. (see full Kiniksa Pharmaceuticals (UK), Ltd. pipeline at /company/kiniksa-pharmaceuticals-uk-ltd).

Is KPL-914 also known as anything else?

KPL-914 is also known as rilonacept.

What development phase is KPL-914 in?

KPL-914 is in Phase 2.

Manufacturer: Kiniksa Pharmaceuticals (UK), Ltd. — full pipeline
Also known as: rilonacept

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