Clinical Trials

Multiple clinical trials across Phase I, Phase I/II, and Phase II evaluate Ricolinostat (ACY-1215) as monotherapy and in combination regimens, such as with nab-paclitaxel, across oncologic and neuropathic conditions including multiple myeloma, metastatic breast cancer, cholangiocarcinoma, lymphoid malignancies, and diabetic peripheral neuropathy. Supported by academic and industry sponsors, these studies display recruitment statuses ranging from completed and active not recruiting to terminated or withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02787369 ACTIVE_NOT_RECRUITING
Recurrent Chronic Lymphoid Leukemia
Dana-Farber Cancer Institute
 2016-05 PHASE1
NCT01997840 TERMINATED
Multiple Myeloma
Celgene
 2014-03-01 PHASE1; PHASE2
NCT05229042 COMPLETED
Peripheral Nervous System Diseases
Beijing 3E-Regenacy Pharmaceuticals Co., Ltd.
 2022-01-01 PHASE1
NCT03176472 COMPLETED
Painful Diabetic Peripheral Neuropathy
Regenacy Pharmaceuticals LLC
 2020-12-07 PHASE2
NCT05193851 COMPLETED
Peripheral Nervous System Diseases
Beijing 3E-Regenacy Pharmaceuticals Co., Ltd.
 2022-01-12 PHASE1
NCT02856568 WITHDRAWN
Non-Resectable Cholangiocarcinoma; Recurrent Cholangiocarcinoma; Stage III Extrahepatic Bile Duct Cancer; Stage III Intrahepatic Cholangiocarcinoma; Stage IIIA Hilar Cholangiocarcinoma; Stage IIIB Hilar Cholangiocarcinoma; Stage IVA Extrahepatic Bile Duct Cancer; Stage IVA Hilar Cholangiocarcinoma; Stage IVA Intrahepatic Cholangiocarcinoma; Stage IVB Extrahepatic Bile Duct Cancer; Stage IVB Hilar Cholangiocarcinoma; Stage IVB Intrahepatic Cholangiocarcinoma; Unresectable Extrahepatic Bile Duct Carcinoma
Mayo Clinic
 2017-05-01 PHASE1
NCT01583283 COMPLETED
Multiple Myeloma
Celgene
 2012-07-12 PHASE1
NCT02632071 COMPLETED
Metastatic Breast Cancer; Breast Carcinoma
Columbia University
 2016-03-01 PHASE1
NCT02091063 TERMINATED
Lymphoma; Lymphoid Malignancies
Jennifer Amengual
 2014-04-02 PHASE1; PHASE2
NCT02189343 COMPLETED
Multiple Myeloma
Celgene
 2014-09-15 PHASE1
NCT02661815 TERMINATED
Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma
Dana-Farber Cancer Institute
 2016-06-15 PHASE1
NCT01323751 COMPLETED
Multiple Myeloma
Celgene
 2011-07 PHASE1; PHASE2
NCT02632071 Completed
Metastatic Breast Cancer|Breast Carcinoma
Columbia University|Acetylon Pharmaceuticals Incorporated|National Cancer Institute (NCI)
 2016-03-01 Phase 1
NCT02088398 COMPLETED
Healthy
Acetylon Pharmaceuticals Incorporated
 2014-03 PHASE1
NCT01583283 Completed
Multiple Myeloma
Celgene
 2012-07-12 Phase 1
NCT01323751 Completed
Multiple Myeloma
Celgene|The Leukemia and Lymphoma Society
 2011-07 Phase 1|Phase 2

(data from https://clinicaltrials.gov, updated on 2026-05-19)

Check the Ricolinostat (ACY-1215) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ricolinostat (ACY-1215) selectively binds to and inhibits histone deacetylase 6 (HDAC6) with an IC50 of 5 nM, blocking intracellular protein degradation pathways and target deacetylation to suppress cell proliferation and induce apoptosis. This targeted disruption of protein homeostasis and cellular survival mechanisms provides the therapeutic rationale for its evaluation in clinical trials for multiple myeloma, metastatic breast cancer, and peripheral neuropathies.

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.