Last reviewed 2026-04-19 · How we verify

Nusivertib

Sumitomo Pharma America, Inc. · Phase 1 active Small molecule

Nusivertib is a Small molecule drug developed by Sumitomo Pharma America, Inc.. It is currently in Phase 1 development. Also known as: TP-3654.

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	Nusivertib
Also known as	TP-3654
Sponsor	Sumitomo Pharma America, Inc.
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

A Study of Oral Nuvisertib (TP-3654) in Patients With Myelofibrosis (PHASE1, 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:

Nusivertib CI brief — competitive landscape report
Nusivertib updates RSS · CI watch RSS
Sumitomo Pharma America, Inc. portfolio CI

Frequently asked questions about Nusivertib

What is Nusivertib?

Nusivertib is a Small molecule drug developed by Sumitomo Pharma America, Inc..

Who makes Nusivertib?

Nusivertib is developed by Sumitomo Pharma America, Inc. (see full Sumitomo Pharma America, Inc. pipeline at /company/sumitomo-pharma-america-inc).

Is Nusivertib also known as anything else?

Nusivertib is also known as TP-3654.

What development phase is Nusivertib in?

Nusivertib is in Phase 1.

Manufacturer: Sumitomo Pharma America, Inc. — full pipeline
Therapeutic area: All drugs in Other
Also known as: TP-3654

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