Last reviewed 2026-05-31 · How we verify

Indoximod Freebase

NewLink Genetics Corporation · Phase 1 active Small molecule ✓ Verified May 2026

Indoximod Freebase is a Small molecule drug developed by NewLink Genetics Corporation. It is currently in Phase 1 development.

Indoximod Freebase is a small molecule that activates the mTORC1 molecular target. It is being studied in combination with idarubicin and cytarabine for the treatment of newly diagnosed acute myeloid leukemia.

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	Indoximod Freebase
Sponsor	NewLink Genetics Corporation
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Study of Indoximod in Combination With (7+3) Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia (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:

Indoximod Freebase CI brief — competitive landscape report
Indoximod Freebase updates RSS · CI watch RSS
NewLink Genetics Corporation portfolio CI

Frequently asked questions about Indoximod Freebase

What is Indoximod Freebase?

Indoximod Freebase is a Small molecule drug developed by NewLink Genetics Corporation.

Who makes Indoximod Freebase?

Indoximod Freebase is developed by NewLink Genetics Corporation (see full NewLink Genetics Corporation pipeline at /company/newlink-genetics-corporation).

What development phase is Indoximod Freebase in?

Indoximod Freebase is in Phase 1.

Manufacturer: NewLink Genetics Corporation — full pipeline

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