Last reviewed 2026-05-19 · How we verify

NeoAg-mBRAF

Craig L Slingluff, Jr · Phase 1 active Small molecule ✓ Verified May 2026

NeoAg-mBRAF is a Small molecule drug developed by Craig L Slingluff, Jr. It is currently in Phase 1 development. Also known as: BRAF 585-614 (V600E).

NeoAg-mBRAF is an intervention being studied in clinical trials for the treatment of Melanoma, Ocular Melanoma, and Uveal Melanoma. The mechanism of NeoAg-mBRAF is not specified in the provided facts, but it is being tested as part of a melanoma vaccine in combination with other interventions.

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	NeoAg-mBRAF
Also known as	BRAF 585-614 (V600E)
Sponsor	Craig L Slingluff, Jr
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Melanoma Vaccine Against Neoantigen and Shared Antigens by CD40 Activation and TLR Agonists In Patients With Melanoma (Including Ocular Melanoma) (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:

NeoAg-mBRAF CI brief — competitive landscape report
NeoAg-mBRAF updates RSS · CI watch RSS
Craig L Slingluff, Jr portfolio CI

Frequently asked questions about NeoAg-mBRAF

What is NeoAg-mBRAF?

NeoAg-mBRAF is a Small molecule drug developed by Craig L Slingluff, Jr.

Who makes NeoAg-mBRAF?

NeoAg-mBRAF is developed by Craig L Slingluff, Jr (see full Craig L Slingluff, Jr pipeline at /company/craig-l-slingluff-jr).

Is NeoAg-mBRAF also known as anything else?

NeoAg-mBRAF is also known as BRAF 585-614 (V600E).

What development phase is NeoAg-mBRAF in?

NeoAg-mBRAF is in Phase 1.

Manufacturer: Craig L Slingluff, Jr — full pipeline
Also known as: BRAF 585-614 (V600E)

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