Last reviewed 2026-05-26 · How we verify

Relatilmab

Washington University School of Medicine · Phase 1 active Biologic ✓ Verified May 2026

Relatilmab is a Biologic drug developed by Washington University School of Medicine. It is currently in Phase 1 development. Also known as: Opdualag.

Relatilmab is being studied in combination with cytokine-induced memory-like natural killer cells and Nivolumab for the treatment of Advanced Melanoma and Metastatic Melanoma. The exact mechanism of Relatilmab is not specified in the provided information, but it is being investigated in a Phase I study.

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	Relatilmab
Also known as	Opdualag
Sponsor	Washington University School of Medicine
Modality	Biologic
Therapeutic area	Other
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Memory-Like Natural Killer Cells With Nivolumab and Relatlimab in Advanced or Metastatic Melanoma After Progression on Checkpoint Inhibitors (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:

Relatilmab CI brief — competitive landscape report
Relatilmab updates RSS · CI watch RSS
Washington University School of Medicine portfolio CI

Frequently asked questions about Relatilmab

What is Relatilmab?

Relatilmab is a Biologic drug developed by Washington University School of Medicine.

Who makes Relatilmab?

Relatilmab is developed by Washington University School of Medicine (see full Washington University School of Medicine pipeline at /company/washington-university-school-of-medicine).

Is Relatilmab also known as anything else?

Relatilmab is also known as Opdualag.

What development phase is Relatilmab in?

Relatilmab is in Phase 1.

Manufacturer: Washington University School of Medicine — full pipeline
Therapeutic area: All drugs in Other
Also known as: Opdualag

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