Clinical Trials

Multiple clinical trials investigate therapeutic strategies across conditions such as glioblastoma, colorectal neoplasms, cholangiocarcinoma, palmoplantar pustulosis, and diabetic neuropathies. Encompassing Phase 1 through Phase 4 trials alongside observational protocols, these studies exhibit recruitment statuses ranging from active and recruiting to completed, terminated, and withdrawn. Supported by academic institutions such as Rush University Medical Center, commercial entities including Janssen Pharmaceutical K.K., and collaborative research groups, these investigations evaluate targeted interventions, such as assessing the safety and efficacy of the IGF-1R inhibitor AXL1717 in malignant gliomas.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07566039 NOT_YET_RECRUITING
Lower Extremity Injury
University of Colorado, Denver
 2026-05-01
NCT07472712 RECRUITING
Prediabetes
Virginia Commonwealth University
 2026-05-26
NCT07681050 RECRUITING
Pancreatitis
Duke University
 2026-07-09 PHASE2
NCT07667101 RECRUITING
HEPATITIS C (HCV)
University of Washington
 2026-06-01
NCT04985344 RECRUITING
PTSD
University Hospital, Toulouse
 2023-02-01 PHASE3
NCT05287867 RECRUITING
Degenerative Disc Disease
Regenexx, LLC
 2022-05-06
NCT04433052 RECRUITING
Coronary Heart Disease
Tampere University
 2023-02-01
NCT06441747 RECRUITING
Cholangiocarcinoma
Australasian Gastro-Intestinal Trials Group
 2024-09-23 PHASE2
NCT04278313 ACTIVE_NOT_RECRUITING
Diminished Ovarian Reserve; Diminished Ovarian Reserve Due to Advanced Maternal Age
Center for Human Reproduction
 2020-02-24
NCT06837805 ENROLLING_BY_INVITATION
Diabetes Mellitus Type 2; Pre-diabetes
Iowa State University
 2025-02-01
NCT05912712 UNKNOWN
Ulcerative Colitis Chronic Moderate; Ulcerative Colitis Chronic Severe; Rectal Ulcer
Xijing Hospital of Digestive Diseases
 2023-07-01 PHASE1
NCT06224556 UNKNOWN
Older People; Non-Communicable Chronic Diseases
Alberto Pilotto
 2024-06-04
NCT06357884 Recruiting
Diabetic Neuropathies|Plantar Callus
Chinese University of Hong Kong|Princess Margaret Hospital Hong Kong
 2024-02-23 Not Applicable
NCT05174065 COMPLETED
Palmoplantar Pustulosis
Amgen
 2022-03-08 PHASE3
NCT05710185 Recruiting
Palmoplantar Pustulosis
Brigham and Women''s Hospital|University of Pennsylvania
 2023-07-01 Phase 4
NCT05733052 UNKNOWN
Urinary Incontinence; Pelvic Floor Disorders
Muğla Sıtkı Koçman University
 2022-06-01
NCT06025422 Recruiting
Diabetic Foot Ulcer|Diabetic Neuropathies
University Hospitals Leicester|University of Salford
 2023-03-13 --
NCT04433052 Recruiting
Coronary Heart Disease
Tampere University
 2023-02-01 Not Applicable
NCT04493424 TERMINATED
Palmoplantar Pustulosis
Boehringer Ingelheim
 2020-09-04 PHASE2
NCT05740137 Active not recruiting
Colorectal Cancer|Colorectal Adenoma|Colorectal Neoplasms
Ismail Gögenur|Nykøbing Falster County Hospital|Naestved Hospital|Holbaek Sygehus|Slagelse Hospital|Zealand University Hospital
 2022-10-01 Not Applicable
NCT04295928 UNKNOWN
Personalized Pharmaceutical Plan After Transpantation
University Hospital, Tours
 2020-10-12
NCT03618979 TERMINATED
Low Back Pain
Regenexx, LLC
 2019-05-02
NCT04502875 UNKNOWN
Erectile Dysfunction
Puerta de Hierro University Hospital
 2020-02-10 PHASE2
NCT04995237 COMPLETED
Quality of Life
Virginia Commonwealth University
 2021-08-05
NCT04015518 COMPLETED
Palmoplantar Pustulosis (PPP)
Boehringer Ingelheim
 2019-07-31 PHASE2
NCT04572997 COMPLETED
Palmoplantar Pustulosis
Kristian Reich
 2018-11-29 PHASE2
NCT02561520 WITHDRAWN
Graft-versus-host Disease
Ladan Espandar
 2016-12 PHASE1
NCT03135548 COMPLETED
Psoriasis
Boehringer Ingelheim
 2017-05-30 PHASE2
NCT02989961 UNKNOWN
Diabetic Foot Ulcer
Hanan Jafar
 2013-11-15 PHASE1; PHASE2
NCT03120988 COMPLETED
Knee Osteoarthritis
Regenexx, LLC
 2016-07 PHASE1
NCT01721577 TERMINATED
Glioblastoma; Gliosarcoma; Anaplastic Astrocytoma; Anaplastic Oligodendroglioma; Anaplastic Oligoastrocytoma; Anaplastic Ependymoma
Rush University Medical Center
 2012-12 PHASE1; PHASE2
NCT01639144 COMPLETED
Elective Foot and Ankle Surgery.
Gary M. Kiebzak, Ph.D.
 2012-07
NCT01245140 COMPLETED
Psoriasis
Stiefel, a GSK Company
 2011-04-26 PHASE2
NCT01812564 COMPLETED
Acute Hamstring Muscle Strain Injury
Aspetar
 2009-11 PHASE2
NCT00601757 COMPLETED
Depression, Postpartum; Depression
Women and Infants Hospital of Rhode Island
 2006-01 PHASE2
NCT00665912 COMPLETED
Lung Cancer
Zimmer Biomet
 2008-01
NCT00686686 COMPLETED
Psoriasis
Merck Sharp & Dohme LLC
 2007-12 PHASE3
NCT02131701 COMPLETED
Family History of Type 2 Diabetes
Folkhälsan Researech Center
 2006-10

(data from https://clinicaltrials.gov, updated on 2026-05-06)

Check the Picropodophyllin (AXL1717) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Picropodophyllin selectively binds to the insulin-like growth factor 1 receptor (IGF-1R) with an IC50 of 1 nM, blocking receptor tyrosine autophosphorylation without inhibiting the insulin receptor to induce cell apoptosis. This selective antineoplastic mechanism provides a strong therapeutic rationale for targeting IGF-1R signaling in clinical trials evaluating aggressive malignancies, including glioblastoma and advanced solid tumors.

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>).

Jump to

Note: Technical data last updated: Sep 1, 2026.