Last reviewed 2026-06-03 · How we verify

MGC026 Dose Escalation

MacroGenics · Phase 1 active Biologic ✓ Verified Jun 2026

MGC026 Dose Escalation is a Biologic drug developed by MacroGenics. It is currently in Phase 1 development.

MGC026 is a small molecule being studied in a Phase 1/1b clinical trial for the treatment of various advanced solid tumors, including non-small cell lung cancer and squamous cell carcinoma of the head and neck. The trial involves a dose escalation study of MGC026, with the goal of determining a safe and effective dose for further evaluation.

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	MGC026 Dose Escalation
Sponsor	MacroGenics
Modality	Biologic
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Study of MGC026 in Participants With Advanced Solid Tumors (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:

MGC026 Dose Escalation CI brief — competitive landscape report
MGC026 Dose Escalation updates RSS · CI watch RSS
MacroGenics portfolio CI

Frequently asked questions about MGC026 Dose Escalation

What is MGC026 Dose Escalation?

MGC026 Dose Escalation is a Biologic drug developed by MacroGenics.

Who makes MGC026 Dose Escalation?

MGC026 Dose Escalation is developed by MacroGenics (see full MacroGenics pipeline at /company/macrogenics).

What development phase is MGC026 Dose Escalation in?

MGC026 Dose Escalation is in Phase 1.

Manufacturer: MacroGenics — full pipeline

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