Clinical Trials

Multiple Phase 1 and Phase 2 clinical trials, sponsored by organizations including Eli Lilly and Company, Endeavor Biomedicines, Inc., and M.D. Anderson Cancer Center, evaluate the therapeutic profile of Taladegib (LY2940680). These early-phase studies assess safety, pharmacokinetics, and efficacy across diverse oncological and non-oncological indications, such as advanced solid tumors harboring PTCH1 loss-of-function mutations, esophageal adenocarcinoma, pediatric medulloblastoma, idiopathic pulmonary fibrosis, and healthy subjects. With recruitment statuses ranging from active recruitment and completion to termination and withdrawal, these investigations highlight the ongoing clinical exploration of Taladegib.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07454291 RECRUITING
Idiopathic Pulmonary Fibrosis
Endeavor Biomedicines, Inc.
 2026-04-28 PHASE1
NCT05199584 COMPLETED
Solid Tumors With PTCH1 Loss-of-function Mutations
Endeavor Biomedicines, Inc.
 2022-05-24 PHASE2
NCT04968574 COMPLETED
Idiopathic Pulmonary Fibrosis
Endeavor Biomedicines, Inc.
 2021-08-26 PHASE2
NCT05817240 COMPLETED
Idiopathic Pulmonary Fibrosis
Endeavor Biomedicines, Inc.
 2023-05-03 PHASE1
NCT02530437 TERMINATED
Gastroesophageal Junction Adenocarcinoma; Stage IB Esophageal Adenocarcinoma AJCC v7; Stage II Esophageal Adenocarcinoma AJCC v7; Stage IIA Esophageal Adenocarcinoma AJCC v7; Stage IIB Esophageal Adenocarcinoma AJCC v7; Stage IIIA Esophageal Adenocarcinoma AJCC v7; Stage IIIB Esophageal Adenocarcinoma AJCC v7
M.D. Anderson Cancer Center
 2017-03-07 PHASE1; PHASE2
NCT02784795 TERMINATED
Solid Tumor; Breast Cancer; Colon Cancer; Cholangiocarcinoma; Soft Tissue Sarcoma
Eli Lilly and Company
 2016-11-04 PHASE1
NCT01697514 WITHDRAWN
Medulloblastoma, Childhood; Rhabdomyosarcoma
Eli Lilly and Company
 2013-07 PHASE1
NCT01919398 COMPLETED
Neoplasm Metastasis
Eli Lilly and Company
 2013-08 PHASE1
NCT01722292 TERMINATED
Small Cell Lung Carcinoma
Eli Lilly and Company
 2013-01 PHASE1; PHASE2
NCT01226485 COMPLETED
Advanced Cancer
Eli Lilly and Company
 2010-09 PHASE1
NCT01919398 Completed
Neoplasm Metastasis
Eli Lilly and Company
 2013-08 Phase 1
NCT01697514 Withdrawn
Medulloblastoma Childhood|Rhabdomyosarcoma
Eli Lilly and Company
 2013-07 Phase 1
NCT01746745 COMPLETED
Healthy Volunteers
Eli Lilly and Company
 2013-01 PHASE1
NCT01746745 Completed
Healthy Volunteers
Eli Lilly and Company
 2013-01 Phase 1
NCT01681186 COMPLETED
Healthy Participants
Eli Lilly and Company
 2012-09 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-05-15)

Check the Taladegib (LY2940680) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Taladegib (LY2940680) selectively binds to the Smoothened receptor, suppressing downstream Hedgehog signal transduction and downregulating oncogenic gene expression within targeted cell populations. By halting signal-dependent cellular proliferation and survival, this inhibition blocks tumor expansion in patients with Hedgehog-driven malignancies, including solid tumors bearing PTCH1 loss-of-function mutations and esophageal adenocarcinomas.

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>).

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