Last reviewed 2026-06-02 · How we verify

PRL3-ZUMAB

Intra-IMMUSG Pte Ltd · Phase 2 active Biologic ✓ Verified Jun 2026

PRL3-ZUMAB is a Biologic drug developed by Intra-IMMUSG Pte Ltd. It is currently in Phase 2 development.

PRL3-ZUMAB is being studied in clinical trials for various conditions, including Neovascular Age Related Macular Degeneration, Gastric Cancer, Hepatocellular Carcinoma, and Advanced Solid Tumors. A Phase I/II study is currently assessing the safety and efficacy of PRL3-ZUMAB in patients with Neovascular Age-related Macular Degeneration (nAMD).

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	PRL3-ZUMAB
Sponsor	Intra-IMMUSG Pte Ltd
Modality	Biologic
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Phase II/III Trial of PRL3-Zumab in Advanced Solid Tumor Patients (PHASE2, PHASE3)
A Study to Assess Safety and Efficacy of PRL3-Zumab in Patients With Solid Tumors (PHASE2)
A First-in-Human Study of PRL3-ZUMAB (PHASE1)
Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors (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:

PRL3-ZUMAB CI brief — competitive landscape report
PRL3-ZUMAB updates RSS · CI watch RSS
Intra-IMMUSG Pte Ltd portfolio CI

Frequently asked questions about PRL3-ZUMAB

What is PRL3-ZUMAB?

PRL3-ZUMAB is a Biologic drug developed by Intra-IMMUSG Pte Ltd.

Who makes PRL3-ZUMAB?

PRL3-ZUMAB is developed by Intra-IMMUSG Pte Ltd (see full Intra-IMMUSG Pte Ltd pipeline at /company/intra-immusg-pte-ltd).

What development phase is PRL3-ZUMAB in?

PRL3-ZUMAB is in Phase 2.

Manufacturer: Intra-IMMUSG Pte Ltd — full pipeline

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