STAT3 Inhibitor Market: Competitive Landscape, Pipeline, and Market Analysis 2024

Signal transducer and activator of transcription 3 (STAT3) is a transcription factor that in humans is encoded by the STAT3 gene. It is a member of the STAT protein family. STAT3 is a member of the STAT protein family. In response to cytokines and growth factors, STAT3 is phosphorylated by receptor-associated Janus kinases (JAK), forms homo- or heterodimers, and translocates to the cell nucleus where it acts as a transcription activator. Specifically, STAT3 becomes activated after phosphorylation of tyrosine 705 in response to such ligands as interferons, epidermal growth factor (EGF), Interleukin (IL-)5, and IL-6. STAT3 inhibits DC maturation and innate immunity through negatively regulating the expression of CXCL10 and CCL5 and so STAT3 inhibitors reverse the action. The mechanism of action (MOA) of STAT3 inhibitors is that they bind and induce cell death in tumor cells in which STAT3 is activated. STAT3 can also be inhibited by decoy ODNs (dODN), which bind STAT3 and induce cell death. STAT3 Inhibitors is used for the treatment of lymphoma, blood coagulation disorders, leukemia, sarcoma, hematologic diseases, glioblastoma, liver diseases, diabetes mellitus, gastroenteritis, hepatitis, etc. Increased prevalence of sarcoma and lymphoma are the key drivers for the STAT3 Inhibitor market. For instance, according to the World Health Organization 2023, non-Hodgkin lymphoma (NHL) is one of the most common cancers in the United States, accounting for about 4% of all cancers. The launch of newer products by the market players could seek opportunities that influence extensive research and development in STAT3 Inhibitor. For instance, Novartis’s Zykadia (Ceritinib) is used for the treatment of ALK+ metastatic non-small cell lung cancer. Moreover, the development of novel molecules by many market players is coming up to overcome challenges in therapy. For instance, Reata Pharmaceuticals Bardoxolone Methyl (RTA 402) for the treatment of connective tissue disease-associated pulmonary arterial hypertension is under the various stages of clinical studies.

Key Market Developments:

• In May 2020, Ariad Pharmaceuticals Alunbrig (Brigatinib) has received FDA approval for additional indication in the first line treatment of adult patients with anaplastic lymphoma kinase positive (ALK+) metastatic non-small cell lung cancer (NSCLC).
• In July 2021, Kadmon’s Rezurock (Belumosudil) has received FDA approval for the indication of patients of age 12 years and older with chronic graft-versus-host disease.

Approved Drug Molecules and Brand Names for STAT3 Inhibitor:

Zykadia (Ceritinib)

Alecensa (Alectinib)

Rezurock (Belumosudil)

Alunbrig (Brigatinib)

Drugs under the Pipeline for STAT3 Inhibitor:

Bardoxolone Methyl (RTA 402)

Ivarmacitinib (SHR0302)

Napabucasin (BBI608)

Danvatirsen (AZD9150)

OPB-111077

Niclosamide Topical (ATX 201)

INB03

Dimethylamino Micheliolide (ACT001)

OPB-31121

OPB-51602

Sulforadex (Sulforafan Alfadex)

TTI-101 Oral

Atiprimod (SK&F106615)

Niclosamide (DWRX2003)

Hl237

WP1066

Anatabine (RCP-006)

Golotimod (SCV 07)

Niclosamide (FW-1022)

Niclosamide Novel Solution

Propranolol

APX3330

PCUR-101

SCR430

WP1220

Curcumin

Luxeptinib (CG-806)

Natura-Alpha (TAK-114)

CO-Stirna (Cpg-STAT3siRNA)

DSP-0337

NT219

Niclonex (Niclosamide Suspension)

SBT-200

Homoharringtonine Derivative (BS-HH-002.SA)

Niclosamide Inhalation (UNI91104)

Pyrimethamine (GLG-801)

Clinical Activity and Developments of STAT3 Inhibitor:

Till June 2023, more than 45 companies having approximately 37 molecules targeting the 72 diseases. For these molecules, more than 59 clinical trials are being conducted and the majority are in phase-2, phase-3 clinical trials by the players across the globe. For instance,

• In November 2022, Reistone Biopharma has completed the phase 3, randomized, double blind and placebo-controlled study of Ivarmacitinib (SHR0302) for the evaluation of safety and efficacy in subjects aged 12 years and older with moderate to severe atopic dermatitis.
• In December 2022, Reata Pharmaceuticals has completed phase 3 Study of Bardoxolone Methyl (RTA 402) for evaluating the safety and efficacy in patients with connective tissue disease-associated pulmonary arterial hypertension.