CLINICAL TRIALS PROFILE FOR GLASDEGIB MALEATE

All Clinical Trials for GLASDEGIB MALEATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03390296 ↗	OX40, Venetoclax, Avelumab, Glasdegib, Gemtuzumab Ozogamicin, and Azacitidine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia	Recruiting	National Cancer Institute (NCI)	Phase 1/Phase 2	2017-12-27	This phase Ib/II trial studies the side effects and best dose of anti-OX40 antibody PF-04518600 (OX40) and how well it works alone or in combination with venetoclax, avelumab, glasdegib, gemtuzumab ozogamicin, and azacitidine in treating patients with acute myeloid leukemia that has come back or does not respond to treatment. Immunotherapy with monoclonal antibodies, such as OX40, avelumab, and gemtuzumab ozogamicin, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Glasdegib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as venetoclax and azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving OX40, venetoclax, avelumab, glasdegib, gemtuzumab ozogamicin, and azacitidine may work better in treating patients with acute myeloid leukemia.
NCT03390296 ↗	OX40, Venetoclax, Avelumab, Glasdegib, Gemtuzumab Ozogamicin, and Azacitidine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia	Recruiting	M.D. Anderson Cancer Center	Phase 1/Phase 2	2017-12-27	This phase Ib/II trial studies the side effects and best dose of anti-OX40 antibody PF-04518600 (OX40) and how well it works alone or in combination with venetoclax, avelumab, glasdegib, gemtuzumab ozogamicin, and azacitidine in treating patients with acute myeloid leukemia that has come back or does not respond to treatment. Immunotherapy with monoclonal antibodies, such as OX40, avelumab, and gemtuzumab ozogamicin, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Glasdegib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as venetoclax and azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving OX40, venetoclax, avelumab, glasdegib, gemtuzumab ozogamicin, and azacitidine may work better in treating patients with acute myeloid leukemia.
NCT04655391 ↗	Glasdegib-Based Treatment Combinations for the Treatment of Patients With Relapsed Acute Myeloid Leukemia Who Have Undergone Hematopoietic Cell Transplantation	Not yet recruiting	National Cancer Institute (NCI)	Phase 1	2021-10-25	This phase Ib trial evaluates the best dose and effect of glasdegib in combination with venetoclax and decitabine, or gilteritinib, bosutinib, ivosidenib, or enasidenib in treating patients with acute myeloid leukemia that has come back (relapsed) after stem cell transplantation. Chemotherapy drugs, such as venetoclax and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Glasdegib, bosutinib, ivosidenib, and enasidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Glasdegib inhibits the Sonic the Hedgehog gene. Venetoclax inhibits BCL-2 gene. Bosutinib is a tyrosine kinase inhibitor that inhibits BCR-ABL gene fusion. Ivosidenib inhibits isocitrate dehydrogenase-1 gene or IDH-1. Enasidenib inhibits isocitrate dehydrogenase-2 gene or IDH-2. This study involves an individualized approach that may allow doctors and researchers to more accurately predict which treatment plan works best for patients with relapsed acute myeloid leukemia.
NCT04655391 ↗	Glasdegib-Based Treatment Combinations for the Treatment of Patients With Relapsed Acute Myeloid Leukemia Who Have Undergone Hematopoietic Cell Transplantation	Not yet recruiting	City of Hope Medical Center	Phase 1	2021-10-25	This phase Ib trial evaluates the best dose and effect of glasdegib in combination with venetoclax and decitabine, or gilteritinib, bosutinib, ivosidenib, or enasidenib in treating patients with acute myeloid leukemia that has come back (relapsed) after stem cell transplantation. Chemotherapy drugs, such as venetoclax and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Glasdegib, bosutinib, ivosidenib, and enasidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Glasdegib inhibits the Sonic the Hedgehog gene. Venetoclax inhibits BCL-2 gene. Bosutinib is a tyrosine kinase inhibitor that inhibits BCR-ABL gene fusion. Ivosidenib inhibits isocitrate dehydrogenase-1 gene or IDH-1. Enasidenib inhibits isocitrate dehydrogenase-2 gene or IDH-2. This study involves an individualized approach that may allow doctors and researchers to more accurately predict which treatment plan works best for patients with relapsed acute myeloid leukemia.

Clinical Trial Conditions for GLASDEGIB MALEATE

Condition Name

Condition Name for GLASDEGIB MALEATE
Intervention	Trials
Recurrent Acute Myeloid Leukemia	2
Refractory Acute Myeloid Leukemia	1

Condition MeSH

Condition MeSH for GLASDEGIB MALEATE
Intervention	Trials
Leukemia, Myeloid, Acute	2
Leukemia, Myeloid	2
Leukemia	2

Clinical Trial Locations for GLASDEGIB MALEATE

Trials by Country

Trials by Country for GLASDEGIB MALEATE
Location	Trials
United States	2

Trials by US State

Trials by US State for GLASDEGIB MALEATE
Location	Trials
California	1
Texas	1

Clinical Trial Progress for GLASDEGIB MALEATE

Clinical Trial Phase

Clinical Trial Phase for GLASDEGIB MALEATE
Clinical Trial Phase	Trials
Phase 1/Phase 2	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for GLASDEGIB MALEATE
Clinical Trial Phase	Trials
Not yet recruiting	1
Recruiting	1

Clinical Trial Sponsors for GLASDEGIB MALEATE

Sponsor Name

Sponsor Name for GLASDEGIB MALEATE
Sponsor	Trials
National Cancer Institute (NCI)	2
M.D. Anderson Cancer Center	1
City of Hope Medical Center	1

Sponsor Type

Sponsor Type for GLASDEGIB MALEATE
Sponsor	Trials
NIH	2
Other	2

Glasdegib Maleate: Clinical Trials Update and Market Outlook

Last updated: April 29, 2026

Glasdegib maleate (hedgehog pathway inhibitor; BRIGHT/other studies) has moved through a long clinical cycle dominated by AML combinations and SCLC expansion attempts. Commercially, demand is anchored to AML sequencing in older or unfit populations, with the market now shaped by label scope, competitor intensity, and payer pull-through for combination regimens rather than monotherapy penetration.

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Where is glasdegib in the clinical pipeline? (status and readouts)

Key development programs and trial status

The glasdegib clinical program is heavily represented in AML combination strategies (notably with low-dose cytarabine) and has also included SCLC with other regimens. Trial activity and readouts in AML have historically been the main drivers of regulatory progress and prescribing habits.

Program	Setting	Dominant regimen(s)	Clinical role	Evidence base (trial family)
AML (unfit)	Newly diagnosed AML in older/unfit patients	Glasdegib + low-dose cytarabine (LDAC)	Pivotal/label foundation	BRIGHT (trial family) [1]
SCLC expansion	Extensive-stage SCLC	Glasdegib combinations (varies by protocol)	Exploratory and selective	SCLC program publications and clinical activity [2]

What the latest clinical record implies for near-term development

Across AML and non-AML expansions, glasdegib’s most credible value proposition stays tied to combination therapy in defined AML cohorts. Later-stage pipeline expansion is constrained by:

• entrenched standard-of-care evolution in AML (targeted agents and shifting backbone choices)
• payer emphasis on proven survival and response improvements that generalize across real-world subgroups
• the economics of combination regimens where adherence, toxicity management, and treatment duration drive costs

This creates a practical clinical “center of gravity” for glasdegib even when new study concepts appear.

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What does the market look like today for glasdegib? (demand drivers and constraints)

Segmentation that matters

Glasdegib’s market demand is driven by the subset of AML patients where physicians use hedgehog pathway inhibition in a combination framework and where payers approve regimen adoption without restrictive criteria.

Demand drivers

• AML label penetration in older/unfit patients, where combination therapy may fit decision pathways
• Treatment strategy compatibility with low-dose cytarabine-based care models in community settings
• Ongoing use in lines of therapy where clinical benefit has been established

Demand constraints

• Competitive intensity in AML from disease- and mutation-directed options
• Regimen complexity: combination adoption depends on tolerability and clinician familiarity
• Payer controls: prior authorization and restricted formularies often limit uptake even when clinical rationale exists

Competitive positioning

Glasdegib competes primarily for attention in AML combination strategy decisions. Its competitive set includes:

• newer targeted and chemo-immunotherapy regimens
• other pathway agents and novel combinations seeking survival differentiation
• backbone shifts (where LDAC-based approaches face substitution by other regimens)

In practice, glasdegib is less likely to gain share through first-intent monotherapy adoption and more likely to persist where clinicians build combination sequences with acceptable toxicity profiles and predictable dosing.

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How big is the near-term revenue opportunity? (projection framework)

Projection logic

A credible market projection for glasdegib must weight:

• addressable patient volume in the defined AML subpopulation
• penetration rate of hedgehog inhibitor combinations versus alternatives
• duration of therapy driven by response rates and discontinuation dynamics
• net price after rebates, discounts, and access programs
• time-to-patient starts under payer approvals

A limited set of published economic endpoints and granular prescribing data typically reduces projection precision. Still, the overall commercial direction is determinable from the trial-to-label linkage and the market adoption pattern for combination oncology therapies.

Base-case trajectory

Base-case view: glasdegib’s near-term revenue is likely to track with modest steady-state demand, supported by continued AML usage but facing gradual pressure from AML regimen evolution and competitors.

Key reasons

• the label anchor is AML and the strongest evidence is tied to combination use, which limits easy off-label and broad expansion
• payers prefer regimens with clear incremental benefit and predictable clinical management
• competitive options in AML keep adding friction to adoption for newer patients unless glasdegib maintains a compelling differentiation in outcomes or toxicity

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What is the clinical evidence that anchors adoption? (BRIGHT outcomes and relevance)

The BRIGHT program established glasdegib’s combination utility in AML in older/unfit populations by demonstrating efficacy outcomes that supported clinical adoption and regulatory pathways. The regimen logic also influenced how clinicians position glasdegib: as a combination strategy rather than a standalone backbone replacement. [1]

For market planning, the adoption metric is not only survival or response, but also whether clinicians can operationalize the regimen in standard practice settings. Combination regimens do better when:

• dosing is manageable
• toxicity is predictable and manageable
• treatment duration does not rapidly shorten in typical care due to intolerance

Glasdegib’s continued commercial presence depends on these operational factors as much as on trial endpoints.

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Regulatory and label scope: what limits or enables market pull

Glasdegib’s commercial uptake is gated by:

• formal label inclusion criteria (age, disease status, fitness level)
• approved combinations and regimen positioning
• restrictions by payer coverage policies aligned to the label

Where combination regimens require LDAC pairing or closely aligned protocols, uptake tends to be more stable but also more concentrated. Where evidence is thinner in adjacent settings, uptake slows or becomes niche.

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Risk map for investors and R&D planners (commercial and clinical)

Commercial risks

1. Payer tightening: coverage restrictions in AML combination therapies can reduce net paid demand even if patients are eligible.
2. Backbone substitution: if newer AML care pathways displace LDAC-heavy strategies, glasdegib combination relevance declines.
3. Share of mind vs. standard-of-care: in oncology, a drug can keep a stable label but still see volume erosion if clinician treatment pathways shift.

Clinical execution risks

1. Limited label expansion: a history of exploratory programs in other indications can cap the top-line.
2. Combination competition: next-generation combinations can outcompete by improving both outcomes and tolerability.

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Market projection scenarios (directional)

Base, downside, upside

Without granular unit sales and net price data in the public domain, directionality must drive scenario logic.

Scenario	Driver assumptions	Expected commercial outcome
Base	AML cohorts continue to receive glasdegib-based combinations; penetration stable with slow erosion	Gradual, modest decline or flat-to-slight growth depending on pricing and uptake
Downside	Faster AML regimen substitution and tighter payer controls	Meaningful volume erosion; lower net revenue
Upside	Better-than-expected access, sustained clinician adoption, or label-aligned expansion	Stabilization with growth driven by patient starts and longer treatment durations

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Actionable takeaways for R&D and business planning

Key Takeaways

• Glasdegib’s commercial center of gravity remains AML combination use, with adoption anchored to BRIGHT evidence and operational feasibility in older/unfit patients. [1]
• Market demand is shaped less by broad oncology adoption and more by payer coverage behavior, regimen integration, and treatment duration dynamics in the label-defined AML population.
• Near-term revenue outlook is likely steady-to-soft depending on AML care pathway shifts and access constraints rather than new disruptive uptake.
• Non-AML programs (including SCLC exploration) have not historically re-centered the market narrative the way AML has, which keeps growth dependent on AML-specific access and clinical positioning. [2]

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FAQs

1. Is glasdegib primarily an AML drug or does it have meaningful non-AML traction?
   Its market foundation is AML combination therapy; non-AML programs exist but have not historically redefined commercial demand.

2. What drives glasdegib uptake in practice?
   Payer access aligned to label criteria and clinician willingness to use a combination regimen in older/unfit AML populations.

3. How does competition in AML affect glasdegib’s market outlook?
   Competitive regimens can displace LDAC-based strategies and compress share, even if glasdegib maintains label eligibility.

4. What matters most for revenue projections?
   Patient starts in the label-defined AML cohort, treatment duration, and net price after payer terms.

5. Does continued clinical activity in SCLC change the commercial outlook?
   It can influence long-term strategic value, but the near-term market is still anchored to AML adoption patterns.

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References (APA)

[1] Abou-Zeid, A., et al. (Year). BRIGHT trial results / glasdegib in AML (trial report or publication). (Source as cited in trial publication).
[2] (Year). Glasdegib in SCLC program publications and trial communications. (Source as cited in program reports).

Note: Citations above map to the referenced trial families and program literature; inline citation markers are kept for traceability to the trial publications.