Last reviewed 2026-05-27 · How we verify

vudalimab monotherapy

Xencor, Inc. · Phase 2 active Biologic ✓ Verified May 2026

vudalimab monotherapy is a Biologic drug developed by Xencor, Inc.. It is currently in Phase 2 development.

Vudalimab is an antibody used in the treatment of metastatic castration-resistant prostate cancer. It has been studied as a monotherapy in a Phase 2 clinical trial for this condition.

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	vudalimab monotherapy
Sponsor	Xencor, Inc.
Modality	Biologic
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

XmAb®20717 (Vudalimab) Alone or in Combination With Chemotherapy or Targeted Therapy in Patients With Metastatic Castration-Resistant Prostate 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:

vudalimab monotherapy CI brief — competitive landscape report
vudalimab monotherapy updates RSS · CI watch RSS
Xencor, Inc. portfolio CI

Frequently asked questions about vudalimab monotherapy

What is vudalimab monotherapy?

vudalimab monotherapy is a Biologic drug developed by Xencor, Inc..

Who makes vudalimab monotherapy?

vudalimab monotherapy is developed by Xencor, Inc. (see full Xencor, Inc. pipeline at /company/xencor-inc).

What development phase is vudalimab monotherapy in?

vudalimab monotherapy is in Phase 2.

Manufacturer: Xencor, Inc. — full pipeline

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