DeepMed Research

Tamibarotene

Generic Name: Tamibarotene

Drug Type: Small Molecule

Chemical Formula: C_₂₂H_₂₅NO_₃

CAS Number: 94497-51-5

Unique Ingredient Identifier: 08V52GZ3H9

Background: Tamibarotene is a novel synthetic retinoid for acute promyelocytic leukaemia (APL). Tamibarotene is currently approved in Japan for treatment of recurrent APL, and is undergoing clinical trials in the United States.

Indication: Investigated for use/treatment in leukemia (unspecified).

Clinical Trials

Study of Tamibarotene in Patients With ADPKD

Phase 2

Active, not recruiting

Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Interventions: Drug: Tamibarotene
Drug: Placebo

First Posted Date: 2024-03-04

Last Posted Date: 2025-04-04

Lead Sponsor: Rege Nephro Co., Ltd.

Target Recruit Count: 70

Registration Number: NCT06289998

Locations: 🇯🇵
Kurume University Hospital, Kurume, Fukuoka, Japan
🇯🇵
Hokkaido University Hospital, Sapporo, Hokkaido, Japan
🇯🇵
Shonan Kamakura General Hospital, Kamakura, Kanagawa, Japan

and more 5 locations

Phase I/II Study of SY-1425 (Tamibarotene) in Combination With Azacitidine and Venetoclax for Patients With Chronic Myelomonocytic Leukemia

Phase 1

Withdrawn

Conditions: Chronic Myelomonocytic Leukemia

Interventions: Drug: Azacitidine
Drug: Tamibarotene
Drug: Venetoclax

First Posted Date: 2023-10-17

Last Posted Date: 2024-03-07

Lead Sponsor: M.D. Anderson Cancer Center

Registration Number: NCT06085638

Investigator-initiated Clinical Trial of MIKE-1

Phase 1

Recruiting

Conditions: Pancreatic Cancer

Interventions: Drug: Am80
Drug: Gemcitabine
Drug: nab-Paclitaxel

First Posted Date: 2021-10-01

Last Posted Date: 2024-04-04

Lead Sponsor: Nagoya University

Target Recruit Count: 55

Registration Number: NCT05064618

Locations: 🇯🇵
Nagoya University Hospital, Nagoya, Aich, Japan
🇯🇵
The University of Tokyo Hospital, Tokyo, Japan

Tamibarotene Plus Venetoclax/Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

Phase 2

Terminated

Conditions: Acute Myeloid Leukemia

Interventions: Drug: Tamibarotene
Drug: Venetoclax
Drug: Azacitidine

First Posted Date: 2021-05-27

Last Posted Date: 2025-02-24

Lead Sponsor: Syros Pharmaceuticals

Target Recruit Count: 66

Registration Number: NCT04905407

Locations: 🇺🇸
Icahn School of Medicine at Mount Sinai, New York, New York, United States
🇫🇷
Hôpital l'Archet- CHU de Nice, Nice, France
🇺🇸
City of Hope, Duarte, California, United States

and more 25 locations

Tamibarotene Plus Azacitidine in Participants With Newly Diagnosed RARA-positive Higher-Risk Myelodysplastic Syndrome

Phase 3

Terminated

Conditions: Myelodysplastic Syndromes

Interventions: Drug: Tamibarotene
Drug: Placebo
Drug: Azacitidine

First Posted Date: 2021-03-15

Last Posted Date: 2025-04-10

Lead Sponsor: Syros Pharmaceuticals

Target Recruit Count: 246

Registration Number: NCT04797780

Locations: 🇪🇸
Hospital San Pedro de Alcántara, Cáceres, Spain
🇦🇹
Salzburg Cancer Research Institute (SCRI), Salzburg, Austria
🇫🇷
CHU Poiters, Poitiers, France

and more 125 locations

A Biomarker-Directed Phase 2 Trial of Tamibarotene (SY-1425) in Participants With Acute Myeloid Leukemia or Myelodysplastic Syndrome

Phase 2

Completed

Conditions: Acute Myeloid Leukemia
Myelodysplastic Syndrome

Interventions: Drug: Tamibarotene
Drug: Azacitidine
Drug: Daratumumab

First Posted Date: 2016-06-21

Last Posted Date: 2024-12-13

Lead Sponsor: Syros Pharmaceuticals

Target Recruit Count: 155

Registration Number: NCT02807558

Locations: 🇫🇷
CHU Amiens, Amiens, France
🇫🇷
Centre Hospitalier de la Côte basque, Bayonne, France
🇫🇷
Centre Hospitalier Universitiaire Hopital Avicenne, Bobigny, France

and more 9 locations

Efficacy and Safety of Tamibarotene(AM80H) for HTLV-1 Associated Myelopathy/ Tropical Spastic Paraparesis (HAM/TSP)

Phase 2

Conditions: HTLV-I-Associated Myelopathy

First Posted Date: 2011-04-28

Last Posted Date: 2011-07-22

Lead Sponsor: St. Marianna University School of Medicine

Target Recruit Count: 15

Registration Number: NCT01343355

Locations: 🇯🇵
Iseikai Medical Corporation, Shoyo Kashiwadai Hospital, Kanagawa, Japan

First Line Study of Tamibarotene in Combination for Advanced Non-Small Cell Lung Cancer

Phase 2

Terminated

Conditions: Stage IV Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer With Pleural Effusion

Interventions: Drug: Placebo
Drug: Tamibarotene

First Posted Date: 2011-04-18

Last Posted Date: 2013-06-28

Lead Sponsor: CytRx

Target Recruit Count: 140

Registration Number: NCT01337154

Locations: 🇮🇳
Dr. Kamakshi Memorial Hospital, Chennai, Pallikaranai, India
🇮🇳
G Kuppuswamy Naidu Memorial Hospital, Valvadi Narayanaswamy Cancer Centre, Coimbatore, Pappanaickenpalayam, India
🇺🇸
Desert Hematology Oncology Medical Group, Inc., Rancho Mirage, California, United States

and more 23 locations

Efficacy and Safety of Tamibarotene(AM80) for Lupus Nephritis

Phase 2

Conditions: Lupus Nephritis

First Posted Date: 2010-10-22

Last Posted Date: 2011-07-22

Lead Sponsor: Kinki University

Target Recruit Count: 20

Registration Number: NCT01226147

Locations: 🇯🇵
Kinki University Hospital, Osaka, Japan

Efficacy and Safety of Tamibarotene (OAM80) for Alzheimer's Disease

Phase 2

Conditions: Alzheimer's Disease

Interventions: Drug: Placebo
Drug: Tamibarotene

First Posted Date: 2010-05-10

Last Posted Date: 2011-07-22

Lead Sponsor: Osaka City University

Target Recruit Count: 50

Registration Number: NCT01120002

Locations: 🇯🇵
Osaka City University Hospital, Osaka, Japan

Drug Development Updates

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