What is PHYRAGO used for?

PHYRAGO is indicated for Chronic Myeloid Leukemia; Acute Lymphoblastic Leukemia.

Is PHYRAGO FDA approved?

Yes, PHYRAGO is FDA approved (first approved 2023-12-05) and manufactured by HANDA THERAP.

PHYRAGO is manufactured by HANDA THERAP.

When does the PHYRAGO patent expire?

PHYRAGO has 720 active patent(s). See patent details for specific expiration dates.

Data updated: May 26, 2026

PHYRAGO (dasatinib)

Genetically Validated

Oncology Approved 2023-12-05

Phyrago (dasatinib) is a kinase

Source: FDA Label • HANDA THERAP

Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How PHYRAGO Works

This drug works by blocking the activity of several proteins, such as BCR-ABL and the SRC family, which drive the uncontrolled growth of leukemia cells. It binds to multiple forms of the ABL kinase, allowing it to remain effective even when the cancer has developed mutations that cause resistance to other medications. By inhibiting these signaling pathways, the drug stops the expansion of cancerous cell lines in the blood and bone marrow.

Source: FDA Label

Indications

Phase 3 Trials

Years on Market

Details

Status: Prescription
First Approved: 2023-12-05
Patent Cliff: 2041
Routes: ORAL
Dosage Forms: TABLET

Companies

HANDA THERAP

Active Ingredient: DASATINIB

PHYRAGO Approval History

2024

2025

2026

Original

New Indication

New Form

Label Update

24 FDA actions from 2023 to 2025 · 1 indication expansions

Aug 2025 SUPPL

Efficacy

FDA Letter Label

Dec 2024 SUPPL

Label · Labeling

FDA Letter Label

Jul 2024 SUPPL

Label · Labeling

FDA Letter Label

Unlock 1 earlier FDA actions Pro

What PHYRAGO Treats

2 indications

PHYRAGO is approved for 2 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.

Chronic Myeloid Leukemia
Acute Lymphoblastic Leukemia

Source: FDA Label

PHYRAGO Target & Pathway

Pro

Target

BCR-ABL (Breakpoint Cluster Region-Abelson) Fusion Protein

An abnormal fusion protein created by a chromosomal translocation, found in chronic myeloid leukemia (CML). BCR-ABL has constitutive kinase activity that drives leukemic cell proliferation. Targeting BCR-ABL transformed CML from a fatal disease to a manageable condition.

PHYRAGO Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Direct competitors

Same target(s) AND same indication — head-to-head.

MoA expansion candidates

Same target(s), different indications — where else is this mechanism being explored?

PAZOPANIB HYDROCHLORIDE

Indication competitors

Same indication, different mechanism — what else might this patient receive?

Unlock 16 more competitors across all three rings.

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

What's emerging in PHYRAGO's indications

See all emerging drugs →

Phase 3 candidates targeting molecules with no FDA-approved drug, in indications PHYRAGO treats. First-in-class if their pivotal trials read out positive.

Ceralasertib AZD6738 ~ Mixed — Ph3 readout

AstraZeneca

ATR · small-molecule ATR kinase inhibitor · 2 Phase 3 trials

Drugs Similar to PHYRAGO

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Clinical Trial Registry

172 trials

Trial	Sponsor ID	Phase	Status	Title
NCT02465060	NCI-2015-00054 NCI-2015-00054, EAY131	Ph 2	active not recruiting	Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
NCT04530565	NCI-2020-06381 NCI-2020-06381, EA9181	Ph 3	active not recruiting	Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults
NCT06124157	NCI-2023-09214 NCI-2023-09214, AALL2131	Ph 2	recruiting	A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL)
NCT04877522	CABL001A2001B 2021-000602-17, 2023-507557-16-00	Ph 4	recruiting	Asciminib Roll-over Study
NCT04872790	STUDY00022691 NCI-2021-01791, STUDY00022691	Ph 1	active not recruiting	Venetoclax, Dasatinib, Prednisone, Rituximab and Blinatumomab for the Treatment of Newly Diagnosed or Relapsed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia or Mixed Phenotype Acute Leukemia
NCT07000734 FOES	202503023	Ph 2	completed	Fortifying Healthy Behaviors, Optimizing Medical Therapies and Enhancing Cognitive Function in Older Adults-pilot Study
NCT07269470	2025-1526 NCI-2025-08780	Ph 2	not yet recruiting	Phase II Study Assessing the Safety and Efficacy of Dasatinib in Combination With Ropeginterferon in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
NCT02883049 results posted	NCI-2011-03797 NCI-2011-03797, S12-01254	Ph 3	active not recruiting	Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations
NCT06390319	SJALL23T NCI-2024-03015	Ph 2	recruiting	Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL)
NCT06533748	SJALL23H NCI-2024-06013	Ph 2	recruiting	Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma
NCT01445509	090019 09-C-0019	Ph 1	completed	Dasatinib in Combination With Bevacizumab to Treat Advanced Solid Tumors
NCT02559778 PEDS-PLAN	NMTRC012	Ph 2	recruiting	Pediatric Precision Laboratory Advanced Neuroblastoma Therapy
NCT04925648 PICASSO	PICASSO	Ph 2	completed	Psma Intensity Can be Altered by Androgen and Phospho-SrC Obstruction
NCT05838560	202302203	Ph 2	active not recruiting	Dasatinib Plus Quercetin for Accelerated Aging in Mental Disorders
NCT02143414 results posted	NCI-2014-01047 NCI-2014-01047, SWOG-S1318	Ph 2	active not recruiting	Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia
NCT01660971	NCI-2012-01290 NCI-2012-01290, VICCGI1173	Ph 1	active not recruiting	Gemcitabine Hydrochloride, Dasatinib, and Erlotinib Hydrochloride in Treating Patients With Pancreatic Cancer That Is Metastatic or Cannot Be Removed by Surgery
NCT00792948 results posted	NCI-2009-00800 NCI-2009-00800, S0805	Ph 2	active not recruiting	Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia
NCT04329325	19-343	Ph 2	active not recruiting	Blinatumomab and Tyrosine Kinase Inhibitor Therapy in People With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
NCT04971226 results posted	CABL001J12301 2023-508838-33-00	Ph 3	active not recruiting	A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP
NCT03516279	EA9171 NCI-2017-02161, EA9171	Ph 2	active not recruiting	Pembrolizumab and Dasatinib, Imatinib Mesylate, or Nilotinib in Treating Patients With Chronic Myeloid Leukemia and Persistently Detectable Minimal Residual Disease
NCT07342491	A5413	Ph 1	not yet recruiting	Dasatinib for HIV-1 Reservoir Reduction
NCT04747912	IRB20-1749	Ph 2	suspended	Study of Chemotherapy-Free Induction Regimen for Ph+ Acute Lymphoblastic Leukemia With Inotuzumab Ozogamicin (InO)
NCT03297606 CAPTUR	PM1 ESR-17-12831, CA209-9DL	Ph 2	recruiting	Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR)
NCT06645886	KQB198-102	Ph 1	active not recruiting	A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Hematologic Malignancies
NCT07493408 ASIM-POST Ph+	ASCPT-01	Ph 2	not yet recruiting	Asciminib & Standard-of-Care Integration in Maintenance Therapy for POST Allogeneic Stem Cell Transplant (Allo-HSCT) of Patient With Ph+ B-ALL or Blastic Transformed CML
NCT07144293 IPACE-HIV	A5426	Ph 2	active not recruiting	Improving Physical Ability and Cellular Senescence Elimination in HIV
NCT06055621 VEN-R DASA	VEN-R DASA-IPC 2022-067	Ph 2	recruiting	Evaluation of DASATINIB Monotherapy Efficacy in Acute Myeloid Leukemia Patients Refractory to VENETOCLAX-AZACITIDINE
NCT02389309	2014-0692 NCI-2015-00524, 2014-0692	Ph 1	active not recruiting	Dasatinib, Temsirolimus, and Cyclophosphamide in Treating Patients With Advanced, Recurrent, or Refractory Solid Tumors
NCT02689440	2015-1040 NCI-2016-00362, 2015-1040	Ph 2	active not recruiting	Dasatinib and Venetoclax in Treating Patients With Philadelphia Chromosome Positive or BCR-ABL1 Positive Early Chronic Phase Chronic Myelogenous Leukemia
NCT05007873	2021-0271 NCI-2021-08486, 2021-0271	Ph 2	recruiting	ASTX727 and Dasatinib for the Treatment of Newly Diagnosed Philadelphia Chromosome or BCR-ABL Positive Chronic Myeloid Leukemia in Chronic Phase
NCT02523976	IIT2015001	Ph 2	completed	Dasatinib Combined With Chemotherapy in Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia
NCT06940297	MC240801 NCI-2025-02490, 24-002915	Ph 2	recruiting	Dasatinib and Quercetin With CAR-T Therapy for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma
NCT03020030	16-001	Ph 3	active not recruiting	Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents
NCT04785300	19-003394	Ph 1, Ph 2	active not recruiting	ALSENLITE: Senolytics for Alzheimer's Disease
NCT03654768 results posted	S1712 NCI-2017-02066, S1712	Ph 2	active not recruiting	Testing the Addition of Ruxolitinib to the Usual Treatment (Tyrosine Kinase Inhibitors) for Chronic Myeloid Leukemia
NCT03117751	TOT17 NCI-2017-00582	Ph 2, Ph 3	active not recruiting	Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma
NCT03595917	18-170	Ph 1	recruiting	ABL001 + Dasatinib + Prednisone + Blinatumomab in BCR-ABL+ B-ALL or CML
NCT05198843 results posted	NCI-2022-00004 NCI-2022-00004, 10480	Ph 1, Ph 2	terminated	Testing an Omega-3 Fatty Acid-Based Anti-Cancer Therapy for Patients With Triple-Negative Inflammatory Breast Cancer That Has Spread to Other Parts of the Body
NCT05993949	IRB-68603 NCI-2023-05591	Ph 1	active not recruiting	Study of Brexucabtagene Autoleucel Plus Dasatinib in Adults With Acute Lymphoblastic Leukemia
NCT05192889 results posted	RAVEN NCI-2022-00304	Ph 1, Ph 2	active not recruiting	Trial Treating Relapsed Acute Lymphoblastic Leukemia With Venetoclax and Navitoclax
NCT05751044 HEM-iSMART B	2022-501866-22-00	Ph 1, Ph 2	recruiting	HEM-iSMART-B: Dasatinib + Venetoclax + Dexamethasone + Cyclophosphamide and Cytarabine in Pediatric Patients With Relapsed or Refractory Hematological Malignancies
NCT00777036 results posted	CA180-226 2008-002260-33	Ph 2	completed	A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML) or With Ph+ Leukemias Resistant or Intolerant to Imatinib
NCT06855810 CCCG-TALL-2025	IIT2025014	Ph 2, Ph 3	recruiting	Newly-diagnosed Pediatric T-cell ALL Protocol
NCT01990196	13-000714 NCI-2015-01448	Ph 2	active not recruiting	Neoadjuvant Phase 2 Study Comparing the Effects of AR Inhibition With/Without SRC or MEK Inhibition in Prostate Cancer
NCT04838041	PRO00040685	Ph 2	recruiting	Protocol Number: HJKC3-0003. Treatment Free Remission After Asciminib Based Therapy in Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients Who Relapsed After a Prior Attempt at TKI Discontinuation
NCT02494882	14-272	Ph 1	active not recruiting	Adding Ruxolitinib to a Combination of Dasatinib Plus Dexamethasone in Remission Induction Therapy in Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Patients Aged 40 Years or Older
NCT02420717 results posted	2014-0521 NCI-2015-00779, 2014-0521	Ph 2	terminated	Ruxolitinib Phosphate or Dasatinib With Chemotherapy in Treating Patients With Relapsed or Refractory Philadelphia Chromosome-Like Acute Lymphoblastic Leukemia
NCT01751425	2012-0697 NCI-2018-01797, 2012-0697	Ph 1	terminated	Ruxolitinib in Treating Participants With Chronic Myeloid Leukemia With Minimal Residual Disease While on Therapy With Tyrosine Kinase Inhibitors
NCT05527418 DASAHIVCURE	2021-001288-26	Ph 2	recruiting	Safety, Tolerance and Antiretroviral Activity of Dasatinib: a Pilot Clinical Trial in Patients With Recent HIV-1 Infection
NCT03560908	IIT2018004	Ph 1	withdrawn	Dasatinib Combined With Chemotherapy in Relapsed t(8;21) Acute Myeloid Leukemia With KIT D816 Mutation

Showing 50 of 172 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

| Show all trials (incl. adjuvant)

Understanding FDA Approval Types

Count	Type	What it means
-	ORIG	Original approval - drug first enters market
-	SUPPL - Efficacy	New indication (new disease/condition approved)
-	SUPPL - Labeling	Label text changes (warnings, dosing updates)
-	SUPPL - Manufacturing	Production changes (new facility)
-	SUPPL - Chemistry	Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

PHYRAGO FDA Label Details

Indications & Usage

FDA Label (PDF)

PHYRAGO is indicated for the treatment of Chronic Myeloid Leukemia; Acute Lymphoblastic Leukemia.

View full patent landscape →

5 OB patents · 1 families · 29 international docs across 7 countries

PHYRAGO Patents & Exclusivity

Latest Patent: Jan 2041

Exclusivity: Dec 2026

Patents (6 active)

US12544376 Expires Jan 22, 2041

US11324745 Expires Jan 22, 2041

US11202778 Expires Jan 22, 2041

US12433891 Expires Jan 22, 2041

US12465606 Expires Jan 22, 2041

US11298356 Expires Jan 22, 2041

Exclusivity

M-307 Until Dec 2026

Source: FDA Orange Book

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Deep insights for PHYRAGO

Revenue Insights

• Quarterly revenue tracking
• Historical trend analysis

Patent Timeline

• Cliff: 2041
• 720 active patents

Trial Analysis

• Clinical trial tracking
• Development stage analysis

Competitive Landscape

• 20 similar drugs
• Same target/indication analysis

Unlock Full Intelligence

Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA216099 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

PHYRAGO (dasatinib)

How PHYRAGO Works

Details

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Companies

PHYRAGO Approval History

What PHYRAGO Treats

PHYRAGO Target & Pathway

Target

PHYRAGO Competitive Set

Direct competitors

MoA expansion candidates

Indication competitors

What's emerging in PHYRAGO's indications

Drugs Similar to PHYRAGO

Clinical Trial Registry

Active Pipeline

Key Completed Trials

Trial Timeline

PHYRAGO FDA Label Details

Indications & Usage

PHYRAGO Patents & Exclusivity

Patents (6 active)

Exclusivity

Pro Intelligence Preview

Revenue Insights

Patent Timeline

Trial Analysis

Competitive Landscape

PHYRAGO Mechanism of Action

PHYRAGO Pharmacokinetics

PHYRAGO Clinical Studies

PHYRAGO Adverse Reactions

PHYRAGO Contraindications

PHYRAGO Warnings & Precautions

PHYRAGO Drug Interactions

PHYRAGO FDA Submission History

PHYRAGO FDA Documents

Data Sources

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PHYRAGO (dasatinib)

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How PHYRAGO Works

Details

Pro Metrics

Companies

PHYRAGO Approval History

What PHYRAGO Treats

PHYRAGO Target & Pathway

Target

PHYRAGO Competitive Set

Direct competitors

MoA expansion candidates

Indication competitors

What's emerging in PHYRAGO's indications

Drugs Similar to PHYRAGO

Clinical Trial Registry

Active Pipeline

Key Completed Trials

Trial Timeline

PHYRAGO FDA Label Details

Indications & Usage

PHYRAGO Patents & Exclusivity

Patents (6 active)

Exclusivity

Related PHYRAGO Products

Pro Intelligence Preview

Revenue Insights

Patent Timeline

Trial Analysis

Competitive Landscape

PHYRAGO Mechanism of Action

PHYRAGO Pharmacokinetics

PHYRAGO Clinical Studies

PHYRAGO Adverse Reactions

PHYRAGO Contraindications

PHYRAGO Warnings & Precautions

PHYRAGO Drug Interactions

PHYRAGO FDA Submission History

PHYRAGO FDA Documents

Data Sources

Competitive Analysis