Dasatinib

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Cat Number

API302962498

CAS Number

302962-49-8

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Product Detail Description Scientific Support Customer Q&A

CAS Number

302962-49-8

EINECS

801-607-0

Storage

Store at room temperature

Synonyms

Sprycel; BMS-354825; Dasatinib anhydrous; Dasatinibum

Molecular Formula

C22H26ClN7O2S

Molecular Weight

488

Smiles

CC1=C(C(=CC=C1)Cl)NC(=O)C2=CN=C(S2)NC3=CC(=NC(=N3)C)N4CCN(CC4)CCO

Appearance

White to off-white solid powder

Melting Point

275-286°C

Relative Density

1.408±0.06 (Predicted)

General Description

Dasatinib is a small-molecule inhibitor of the tyrosine kinase enzyme BCR-ABL, belonging to the class of kinase inhibitors. Its chemical structure is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)piperazin-1-yl]-2-methylpyrimidin-4-yl]amino]-1,3-thiazole-5-carboxamide. Dasatinib is a white to off-white powder, practically insoluble in water. It is a multi-kinase inhibitor with activity against SRC, KIT, and PDGFR.

Mechanism of Action

Dasatinib binds to both the active and inactive conformations of the BCR-ABL kinase, inhibiting its activity and blocking the downstream signaling pathways that promote cell proliferation and survival. The drug also inhibits other kinases, including SRC, KIT, and PDGFR, which may contribute to its efficacy. It is effective against many imatinib-resistant BCR-ABL mutants, including the T315I mutation.

Application

Dasatinib is indicated for the treatment of chronic myeloid leukemia (CML) in adults, including patients with resistance or intolerance to imatinib, and for the treatment of Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). It is also used for the treatment of other malignancies, such as gastrointestinal stromal tumors (GISTs). The drug is effective in inducing complete cytogenetic and molecular responses.

In a phase 1 study of 24 patients with Philadelphia chromosome-positive acute lymphoblastic leukemia or lymphoid blast crisis, dual BCR::ABL1 inhibition with dasatinib 140 mg daily plus asciminib (recommended phase 2 dose: 80 mg daily) plus prednisone was safe and active. At day 84, all patients achieved complete cytogenetic remission, 89% achieved MRD negativity by flow cytometry, and 74% had BCR::ABL1 <0.1% by RT-qPCR. The only dose-limiting toxicity was asymptomatic pancreatic enzyme elevation. Vaso-occlusive events were absent. This combination is promising for de novo Ph+ ALL.

Fig. 1 Molecular responses deepened over time with dasatinib and asciminib combination therapy. (Luskin MR, et al., 2025)

References

Luskin MR, et al. Asciminib plus dasatinib and prednisone for Philadelphia chromosome-positive acute leukemia. Blood. 2025;145(6):577-589.

Does Dasatinib require protection from moisture during long‑term storage?

Yes, it is slightly hygroscopic and susceptible to hydrolysis of the amide and thiazole groups. Store in tightly sealed containers with desiccant.

What is the recommended storage temperature for Dasatinib?

Store at controlled room temperature (15–25°C). Avoid temperatures above 30°C, which can accelerate oxidative degradation and discoloration.

Is Dasatinib stable in tablet formulations with standard excipients?

Yes, when formulated with moisture‑protective packaging (e.g., HDPE bottles with desiccant).

How is the impurity dasatinib N‑oxide (an oxidative degradation product) monitored?

This degradation product is quantified using a stability‑indicating HPLC method, ensuring it remains within ICH qualification thresholds.