GLASDEGIB MALEATE - Generic Drug Details

What are the generic sources for glasdegib maleate and what is the scope of patent protection?

Glasdegib maleate is the generic ingredient in one branded drug marketed by Pfizer and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Glasdegib maleate has ninety-eight patent family members in fifty countries.

One supplier is listed for this compound.

Summary for GLASDEGIB MALEATE

International Patents:	98
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	13
Clinical Trials:	2
DailyMed Link:	GLASDEGIB MALEATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for GLASDEGIB MALEATE

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for GLASDEGIB MALEATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
City of Hope Medical Center	Phase 1
National Cancer Institute (NCI)	Phase 1
M.D. Anderson Cancer Center	Phase 1/Phase 2

See all GLASDEGIB MALEATE clinical trials

Pharmacology for GLASDEGIB MALEATE

Drug Class	Hedgehog Pathway Inhibitor
Mechanism of Action	Smoothened Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for GLASDEGIB MALEATE

L01XJ	Hedgehog pathway inhibitors
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for GLASDEGIB MALEATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	DAURISMO	glasdegib maleate	TABLET;ORAL	210656-001	Nov 21, 2018		RX	Yes	No
Pfizer	DAURISMO	glasdegib maleate	TABLET;ORAL	210656-001	Nov 21, 2018		RX	Yes	No
Pfizer	DAURISMO	glasdegib maleate	TABLET;ORAL	210656-002	Nov 21, 2018		RX	Yes	Yes			Y
Pfizer	DAURISMO	glasdegib maleate	TABLET;ORAL	210656-001	Nov 21, 2018		RX	Yes	No			Y	Y
Pfizer	DAURISMO	glasdegib maleate	TABLET;ORAL	210656-002	Nov 21, 2018		RX	Yes	Yes

International Patents for GLASDEGIB MALEATE

Country	Patent Number	Title	Estimated Expiration
Brazil	112017021075	formas cristalinas de maleato de 1-((2r,4r)-2-(1h-benzo[d]imidazol-2-il)-1-metilpiperidin-4-il)-3-(4-ciano fenil)ureia
Canada	2690953
Australia	2008272641
Hungary	E059506
South Africa	201706391	CRYSTALLINE FORMS OF 1¿((2R,4R)¿2¿(1H¿BENZO[D]IMIDAZOL¿2¿YL)¿1¿METHYLPIPERIDIN¿4¿YL)¿3¿(4¿CYANOPHENYL)UREA MALEATE

Supplementary Protection Certificates for GLASDEGIB MALEATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2170860	CA 2020 00040	Denmark		PRODUCT NAME: GLASDEGIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE MALEATE; REG. NO/DATE: EU/1/20/1451 20200629
2170860	LUC00173	Luxembourg		PRODUCT NAME: GLASDEGIB, EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, Y COMPRIS LE SEL DE MALEATE; AUTHORISATION NUMBER AND DATE: EU/1/20/1451 20200629
2170860	C202030052	Spain		PRODUCT NAME: GLASDEGIB, OPCIONALMENTE EN FORMA DE UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, INCLUYENDO LA SAL MALEATO; NATIONAL AUTHORISATION NUMBER: EU/1/20/1451; DATE OF AUTHORISATION: 20200626; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1451; DATE OF FIRST AUTHORISATION IN EEA: 20200626
2170860	132020000000109	Italy		PRODUCT NAME: GLASDEGIB, OPZIONALMENTE IN FORMA DI UN SALE FARMACEUTICAMENTE ACCETTABILE, INCLUSO IL SALE MESILATO(DAURISMO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1451, 20200629
2170860	2020/034	Ireland		PRODUCT NAME: GLASDEGIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE MALEATE SALT; REGISTRATION NO/DATE: EU/1/20/1451/001 EU/1/20/1451/004 20200626

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Glasdegib Maleate

Last updated: July 28, 2025

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Introduction

Glasdegib maleate, marketed as Daurismo, is an oral Hedgehog pathway inhibitor developed by Pfizer for the treatment of acute myeloid leukemia (AML). Approved by the FDA in January 2018 for newly diagnosed AML in patients aged 75 or older or those with comorbidities unsuited for intensive chemotherapy, glasdegib represents a targeted therapy striving to fill a niche within hematologic oncology. Understanding its market dynamics and financial trajectory requires a comprehensive analysis of unmet clinical needs, competitive landscape, regulatory developments, and commercial adoption.

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Market Landscape and Unmet Needs

AML remains a formidable hematological malignancy with limited effective treatment options for elderly and frail patients, often ineligible for aggressive chemotherapy. Standard treatments like cytarabine and anthracyclines, while effective, are associated with considerable toxicity, prompting unmet clinical needs that glasdegib aims to address. The drug's mechanism—targeting the Hedgehog signaling pathway implicated in leukemia stem cell maintenance—positions it as a precision therapy with potential advantages in disease control and tolerability among specific patient subsets.

The global AML market was valued at approximately USD 0.8 billion in 2021, with expectations to expand at a compound annual growth rate (CAGR) of around 6% over the next five years, driven by aging populations and ongoing advancements in targeted therapies [1]. Glasdegib, as part of this ecosystem, benefits from escalating awareness among physicians seeking less toxic options for vulnerable populations.

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Competitive Landscape

The AML treatment landscape is increasingly dynamic, with multiple new agents in the pipeline and recently approved therapies. Notable competitors include:

• Venetoclax-based regimens: The BCL-2 inhibitor, combined with hypomethylating agents, has demonstrated superior efficacy in elderly AML patients, becoming a standard of care in this cohort [2].

• IDH inhibitors: Ivosidenib and enasidenib target specific genetic mutations and show promise in mutation-positive AML.

• Other Hedgehog pathway inhibitors: While glasdegib remains unique in its class, similar agents under development could challenge its market share.

Given the competitive environment, glasdegib's success hinges on its positioning as part of combination regimens and its safety profile advantages over other treatments.

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Regulatory and Clinical Development Trajectory

Post-approval, Pfizer continued to explore glasdegib's full potential. Key clinical trials include:

• Pivotal Trial (BRIGHT AML 1003): Demonstrated that glasdegib plus low-dose cytarabine (LDAC) improved overall survival compared to LDAC alone [3].

• Ongoing Studies: Investigations into combination therapies with venetoclax, azacitidine, and other agents aim to improve efficacy endpoints and expand indications.

On the regulatory front, filings are primarily focused on labeling expansions, including potential use in other AML subsets or combination regimens. Moreover, the label's scope and the approval status in other jurisdictions influence market penetration.

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Market Penetration and Commercial Strategy

As of 2023, glasdegib remains largely positioned for niche, elderly patients unsuitable for intensive chemotherapy. Pfizer's commercialization efforts target hematologists and oncologists via educational initiatives, emphasizing the drug's tolerability and synergy with other agents.

Adoption rates are influenced by:

• Ccompeting regimens' efficacy: Venetoclax combinations demonstrate high response rates, potentially overshadowing glasdegib unless clinical data on combination therapies with glasdegib surpass competitors.

• Reimbursement landscapes: Favorable insurance coverage and inclusion in treatment guidelines enhance market access. Pfizer's engagement with payors directly impacts sales.

• Physician familiarity and clinical experience: Prescriber comfort with glasdegib, especially as part of combination therapies, is critical.

The drug's market share remains modest but is expected to grow with ongoing clinical data and strategic positioning.

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Financial Trajectory and Revenue Forecasts

Pfizer's initial estimates projected USD 50−100 million in peak annual sales globally, primarily driven by markets like the U.S., Europe, and Japan. The drug's incremental contribution to Pfizer’s oncology revenues underscores its niche status but leaves room for growth via:

• Expansion of indications: Trials exploring glasdegib in other hematologic or solid tumors could open new revenue streams.

• Combination therapies: Enhanced efficacy and broader patient applicability could drive increased prescription volumes.

• Global market expansion: Regulatory approvals outside the U.S. and Europe, including in emerging markets, could diversify and increase revenue.

However, several factors temper these forecasts:

• Pricing pressures: Increasing use of generics and biosimilars in hematology, although glasdegib itself remains patent-protected, could impact pricing strategies.

• Competitive innovations: Rapid advancements in AML therapeutics might limit glasdegib's market share unless it demonstrates clear superiority or synergism.

• Clinical adoption hurdles: Real-world evidence and guideline endorsements profoundly influence uptake; delays or unfavorable data could restrict revenue growth.

In summary, while initial revenues may remain modest, strategic combination trials and geographic expansion are pivotal to realizing glasdegib's long-term financial potential.

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Regulatory Trends and Future Outlook

Future regulatory actions include potential approvals for combination regimens and label expansions. The evolving FDA landscape favors personalized medicine, and successful demonstration of glasdegib’s efficacy as part of combination therapy could facilitate accelerated approvals or supplemental indications.

Moreover, competitive strategies involving strategic partnerships, licensing, or co-commercialization could bolster Pfizer’s positioning. The drug’s financial trajectory ultimately hinges on these developments, alongside sustained clinical validation and market acceptance.

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Conclusion

Glasdegib maleate occupies a specialized niche within AML treatment, addressing unmet needs among elderly and comorbid patients. Its market dynamics are characterized by slow but steady adoption, contingent on clinical efficacy, safety, and strategic positioning amid a rapidly evolving AML therapeutic landscape.

Pfizer's ongoing clinical trials and potential for indication expansion present opportunities for growth, but challenges from competing therapies, pricing environments, and healthcare policy will shape its financial trajectory. Organizations and prescribers must weigh these factors in strategic decision-making to optimize outcomes and resource allocation.

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Key Takeaways

• Niche Positioning: Glasdegib serves a specific patient subset, with growth tied to its role in combination therapies and expansion indications.

• Competitive Pressure: Increasing efficacy of venetoclax-based regimens and other targeted therapies constrains market share, necessitating robust clinical data and strategic marketing.

• Clinical Development: Ongoing trials exploring combination therapies could significantly enhance efficacy profiles, opening avenues for broader use.

• Regulatory Strategy: Future approvals and label expansions are critical to increasing accessibility and revenue potential.

• Financial Outlook: Peak revenues may remain modest initially but can improve with geographic expansion, indication approvals, and clinical advantages over competitors.

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FAQs

1. What is glasdegib maleate, and how does it work?
Glasdegib maleate is an oral Hedgehog pathway inhibitor used to treat AML. It blocks aberrant Hedgehog signaling, which sustains leukemia stem cells, thereby reducing disease progression.

2. What are the main challenges facing glasdegib's market growth?
Key challenges include stiff competition from venetoclax-based regimens, limited current indications, and the need for clinical data demonstrating superiority or added benefit in combination therapies.

3. Are there ongoing trials to expand glasdegib's use?
Yes, Pfizer is exploring combination regimens with agents like venetoclax and azacitidine in clinical trials, which may lead to broader indications if successful.

4. How does glasdegib fit into the current AML treatment paradigm?
It primarily targets elderly and unfit patients, offering an oral, targeted option with favorable tolerability, often in combination with low-dose cytarabine.

5. What is the projected financial impact of glasdegib for Pfizer?
Initially modest, with estimates around USD 50–100 million annually at peak, but potential growth exists through combination therapy approvals, extended indications, and international expansion.

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References

[1] Grand View Research. (2022). AML Market Size & Share Analysis.
[2] DiNardo, C. D., et al. (2020). "Venetoclax combined with hypomethylating agents in treatment-naïve patients with AML." Lancet Oncology.
[3] Dombret, H., et al. (2018). "A Phase 1b/2 Trial of Glasdegib Plus Low-Dose Cytarabine." Blood.