Last reviewed 2026-06-03 · How we verify

Sovilnesib

Volastra Therapeutics, Inc. · Phase 1 active Small molecule ✓ Verified Jun 2026

Sovilnesib is a Small molecule drug developed by Volastra Therapeutics, Inc.. It is currently in Phase 1 development.

Sovilnesib is a small molecule inhibitor of KIF18A, a protein involved in chromosomal instability. It is being studied in a Phase 1b clinical trial (NCT06084416) for the treatment of high-grade serous adenocarcinoma of the ovary, fallopian tube cancer, primary peritoneal carcinoma, and other conditions associated with chromosomal instability.

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	Sovilnesib
Sponsor	Volastra Therapeutics, 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 Sovilnesib in Subjects With Ovarian Cancer (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:

Sovilnesib CI brief — competitive landscape report
Sovilnesib updates RSS · CI watch RSS
Volastra Therapeutics, Inc. portfolio CI

Frequently asked questions about Sovilnesib

What is Sovilnesib?

Sovilnesib is a Small molecule drug developed by Volastra Therapeutics, Inc..

Who makes Sovilnesib?

Sovilnesib is developed by Volastra Therapeutics, Inc. (see full Volastra Therapeutics, Inc. pipeline at /company/volastra-therapeutics-inc).

What development phase is Sovilnesib in?

Sovilnesib is in Phase 1.

Manufacturer: Volastra Therapeutics, Inc. — full pipeline
Therapeutic area: All drugs in Other

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