Indoximod Clinical Trials

Size	Price	Qty
50mg	USD 147
200mg	USD 297

Clinical Trials

Indoximod has been evaluated in multiple Early Phase 1, Phase 1, and Phase 2 clinical trials targeting advanced melanoma, pediatric and adult central nervous system malignancies (including glioblastoma, medulloblastoma, and ependymoma), metastatic pancreatic adenocarcinoma, non-small cell lung cancer, solid tumors, and pharmacokinetic profiling in healthy volunteers. Sponsored by pharmaceutical companies, academic institutions, and medical centers, these studies encompass diverse recruitment statuses, including completed, recruiting, terminated, and withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07732413	NOT_YET_RECRUITING	Progressive Pediatric Brain Cancer	Lumos Pharma	2026-10-08	PHASE1
NCT05106296	RECRUITING	Ependymoma; Medulloblastoma; Glioblastoma; Primary Brain Tumor	Theodore S. Johnson	2022-02-08	PHASE1
NCT04049669	ACTIVE_NOT_RECRUITING	Glioblastoma; Medulloblastoma; Ependymoma; Diffuse Intrinsic Pontine Glioma	Theodore S. Johnson	2019-10-02	PHASE2
NCT05469490	WITHDRAWN	Advanced Solid Tumors	Luke, Jason, MD	2022-10	PHASE1
NCT02502708	COMPLETED	Glioblastoma Multiforme; Glioma; Gliosarcoma; Malignant Brain Tumor; Ependymoma; Medulloblastoma; Diffuse Intrinsic Pontine Glioma; Primary CNS Tumor	NewLink Genetics Corporation	2015-10	PHASE1
NCT02835729	COMPLETED	Acute Myeloid Leukemia	NewLink Genetics Corporation	2016-07	PHASE1
NCT03301636	TERMINATED	Melanoma	NewLink Genetics Corporation	2017-12-08	PHASE2
NCT01560923	COMPLETED	Metastatic Prostate Cancer	Masonic Cancer Center, University of Minnesota	2012-10-01	PHASE2
NCT02052648	COMPLETED	Glioblastoma Multiforme; Glioma; Gliosarcoma; Malignant Brain Tumor	NewLink Genetics Corporation	2014-03	PHASE1; PHASE2
NCT03852446	COMPLETED	Healthy	NewLink Genetics Corporation	2018-03-05	EARLY_PHASE1
NCT03372239	COMPLETED	Healthy	NewLink Genetics Corporation	2017-11-21	PHASE1
NCT02073123	COMPLETED	Metastatic Melanoma; Stage III Melanoma; Stage IV Melanoma	NewLink Genetics Corporation	2014-07	PHASE1; PHASE2
NCT02077881	COMPLETED	Metastatic Pancreatic Adenocarcinoma; Metastatic Pancreatic Cancer	NewLink Genetics Corporation	2014-08	PHASE1; PHASE2
NCT03301636	Terminated	Melanoma	NewLink Genetics Corporation\|Lumos Pharma	2017-12-08	Phase 2
NCT02460367	TERMINATED	Non-small Cell Lung Cancer; Progression of Non-small Cell Lung Cancer; Non-small Cell Lung Cancer Recurrent	NewLink Genetics Corporation	2016-01	PHASE1
NCT01792050	COMPLETED	Metastatic Breast Cancer	NewLink Genetics Corporation	2013-02	PHASE2
NCT00739609	TERMINATED	Breast Cancer; Lung Cancer; Melanoma; Pancreatic Cancer; Solid Tumors	NewLink Genetics Corporation	2008-08	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-07-28)

Check the Indoximod product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Indoximod is a methylated tryptophan derivative that acts as an indoleamine-(2,3)-dioxygenase pathway inhibitor, disrupting downstream tryptophan depletion and kynurenine-mediated immunosuppressive signaling within the microenvironment. Reversing this immune suppression restores T-cell activation and proliferation, ultimately enhancing host anti-tumor immune responses in clinical settings such as melanoma, pediatric brain tumors, and pancreatic cancer.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).