CLINICAL TRIALS PROFILE FOR DAURISMO

All Clinical Trials for DAURISMO

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 DAURISMO

Condition Name

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

Condition MeSH

Condition MeSH for DAURISMO
Intervention	Trials
Leukemia, Myeloid, Acute	2
Leukemia, Myeloid	2
Leukemia	2

Clinical Trial Locations for DAURISMO

Trials by Country

Trials by Country for DAURISMO
Location	Trials
United States	2

Trials by US State

Trials by US State for DAURISMO
Location	Trials
California	1
Texas	1

Clinical Trial Progress for DAURISMO

Clinical Trial Phase

Clinical Trial Phase for DAURISMO
Clinical Trial Phase	Trials
Phase 1/Phase 2	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for DAURISMO
Clinical Trial Phase	Trials
Not yet recruiting	1
Recruiting	1

Clinical Trial Sponsors for DAURISMO

Sponsor Name

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

Sponsor Type

Sponsor Type for DAURISMO
Sponsor	Trials
NIH	2
Other	2

Last updated: May 21, 2026

URISMO (glasdegib) Clinical Trials Update, Market Analysis, and 2026–2035 Projection

Executive summary: DAURISMO (glasdegib) is an oral inhibitor of Hedgehog pathway signaling that is marketed by Pfizer for combination use with low-dose cytarabine (LDAC) in newly diagnosed acute myeloid leukemia (AML) patients age 75 years or older or unfit for intensive chemotherapy, and with cytarabine in other defined AML populations per labeling. Commercial performance has been constrained by limited addressable incidence, competition from venetoclax-based regimens, and adoption barriers for older/unfit patients. The near-term outlook is driven by (1) continued use in labeled AML combinations where tolerability and regimen fit align with real-world treatment patterns, and (2) incremental trial readouts in AML and related myeloid settings that can support label expansion or line-of-therapy shifts.

What is DAURISMO (glasdegib) and where is it approved?

Featured answer: DAURISMO is glasdegib, an oral small-molecule Hedgehog pathway inhibitor. Its core approved commercial use is in AML in combination with LDAC for older or unfit patients, with a regulatory history centered on safety and efficacy in a pivotal combination trial versus LDAC alone.

Which indication is the main revenue driver?

• Newly diagnosed AML in combination with LDAC for patients age 75 years or older or unfit for intensive chemotherapy.
• The market for this segment depends on: (1) diagnosis rates of AML in older patients, (2) proportion deemed “unfit” for intensive induction, and (3) how often clinicians choose Hedgehog inhibition over alternatives.

How does label scope affect uptake?

Label language tied to “unfit for intensive chemotherapy” tends to reduce eligible patient counts relative to broader “front-line” labels. Real-world adoption typically correlates with:

• clinician comfort with safety profile in elderly patients,
• expected benefit magnitude versus LDAC-only,
• and competitive regimen availability (notably venetoclax combinations).

What clinical trials update exists for glasdegib in AML?

Featured answer: Current clinical direction for glasdegib is concentrated on AML and myeloid malignancy combinations, with emphasis on activity signals in front-line and salvage contexts, and with iterative refinement of dosing and pairing partners to improve depth and duration of response.

Which trial questions still matter commercially?

1. Can glasdegib improve response quality versus standard-of-care LDAC-based approaches?
2. Can it outperform, or find a niche alongside, venetoclax regimens in older/unfit patients?
3. Does it support sequencing in later lines where Hedgehog signaling may have a differential impact?
4. Does it have a tolerability profile that supports combination durability in frail populations?

Why trial outcomes translate into market share

Even small improvements in overall response rate or duration of response can matter because the target population is narrow and competitive options are expanding. Commercial upside requires one of:

• clearer comparative efficacy, or
• a practical advantage (tolerability, fewer discontinuations, outpatient schedule fit) that changes clinician behavior.

What patents protect DAURISMO (glasdegib) and how long does exclusivity last?

Featured answer: Glasdegib’s IP estate is anchored by multiple composition, crystalline/form, salt, and method-of-use patents, with expirations staggered across jurisdictions and related to formulation and combination use.

How patent expiry changes generic entry risk

• As patents and regulatory exclusivity approach expiry, generic and authorized generic strategies become time-sensitive.
• Combination-specific method claims can delay “skinny” carve-outs if the generic cannot lawfully induce infringement by marketing instructions.

Paragraph IV and litigation as the gating factor

If a Paragraph IV filing targets core composition or use claims, litigation becomes the gating event for market entry timing. Settlement terms, if any, determine launch dates and carve-out eligibility.

What is the Orange Book status of DAURISMO and how does it impact generics?

Featured answer: Orange Book listing determines whether a generic applicant must address specific listed patents tied to the marketed product and dosage form. Patent-by-patent “Hitchhiker” risk exists if generics can design around certain formulation or use claims while still targeting the core active ingredient.

What to look for in Orange Book listings

• Patent numbers and expiration dates by product/strength.
• Whether the listed patents include method-of-use and dosing regimen claims.
• Whether there are multiple relevant listings for different strengths or dosage forms.

How does DAURISMO compare with venetoclax-based regimens for AML in the same patient segment?

Featured answer: Venetoclax-based regimens generally dominate AML combination adoption due to strong response rates and broad guideline visibility, making glasdegib’s commercial penetration dependent on niche fit within older/unfit populations.

Competitive positioning

• Venetoclax + HMA (hypomethylating agent) is a common default in older/unfit AML.
• LDAC + glasdegib offers an alternative path where clinicians prefer LDAC-based regimens or where patient-specific factors affect regimen selection.
• Glasdegib’s uptake tends to track the availability and familiarity of partners, regimen manageability, and real-world discontinuation rates.

What generic entry risks exist for DAURISMO (glasdegib)?

Featured answer: Generic entry risk is driven by the time remaining on core composition and method-of-use patents and by whether Orange Book-listed patents cover clinically meaningful combination instructions.

Launch scenario structure

A typical risk model for a complex oncology oral:

• If core composition patents remain active, entry is blocked until expiry or settlement.
• If only certain formulation patents persist, generics can launch with design-arounds, subject to non-infringement.
• If method-of-use claims remain enforceable, labeling carve-outs may still be required to avoid induced infringement.

Market analysis: How big is the DAURISMO addressable market and what drives penetration?

Featured answer: The addressable market for glasdegib is the subset of newly diagnosed AML patients who are older or unfit for intensive chemotherapy and in whom clinicians select a LDAC-based approach combined with a Hedgehog inhibitor. Penetration is constrained by competition from widely used venetoclax combinations.

Core demand drivers

• AML incidence in the relevant age group.
• Rate of “unfit for intensive chemotherapy” designation.
• Adoption share of LDAC-based regimens relative to HMA- and venetoclax-based combinations.
• Persistence and discontinuation rates in real-world practice.

Key market frictions

• Multiple effective regimens exist, reducing incremental share gains.
• Oral dosing is not itself a differentiator unless tolerability and schedule improve adherence.
• Hospital formularies and treatment pathways can limit switching from entrenched regimens.

Revenue projection for DAURISMO (glasdegib): 2026–2035

Featured answer: Glasdegib’s revenue trajectory is expected to follow a “competitive pressure with limited expansion” pattern, with modest growth only if clinical evidence supports label expansion, sequencing adoption, or demonstrable differentiation versus standard-of-care combinations.

Projection logic

The projection assumes:

• no major guideline displacement from venetoclax-dominant regimens without new, statistically and clinically meaningful comparative data,
• steady-to-declining unit demand in the labeled LDAC combination segment as penetration matures,
• limited incremental markets unless trials support additional indications or improved line-of-therapy placement.

Indicative base-case revenue path (directional)

A plausible base-case pattern for a mature, niche oncology oral with constrained competitive differentiation:

• 2026–2028: stable-to-slight decline as competitive uptake continues.
• 2029–2032: gradual stabilization if trial readouts support continued clinical use in subsets.
• 2033–2035: decline unless patent/label events extend commercial life or new approvals broaden the addressable population.

(No numeric revenue forecast can be stated accurately without product sales history, current market share, and finalized clinical event outcomes.)

What clinical readouts would change the DAURISMO outlook most?

Featured answer: The highest impact is label-relevant evidence that either (1) improves survival endpoints in the targeted older/unfit segment versus a venetoclax-based control, or (2) moves glasdegib into a broader line-of-therapy with measurable benefit and acceptable safety in the real-world treatment setting.

Decision points for investors and commercial leaders

• Survival benefit versus the best available regimen in an adequately powered trial.
• Reduced discontinuation rates or better tolerability that drives sustained use in elderly populations.
• Durable response and rates of MRD negativity (where evaluated) that support clinical differentiation.

Key Takeaways

• DAURISMO (glasdegib) is a Hedgehog pathway inhibitor used in AML in combination with LDAC in older or unfit patients, with uptake shaped primarily by regimen fit against venetoclax- and HMA-based standards.
• Clinical trial progress matters most if it enables label expansion, sequencing adoption, or comparative differentiation that changes guideline and formulary behavior.
• Generic and biosimilar entry risk hinges on the remaining patent-life on Orange Book-listed composition and method-of-use claims and on Paragraph IV dynamics.
• Market projections are constrained by a narrow eligible population and intensifying competition; the outlook improves only with label-relevant efficacy/tolerability evidence or a broadened indication scope.

FAQs

1. When could DAURISMO (glasdegib) lose exclusivity in the US based on patent and regulatory timelines?
2. Which AML combination regimens are most likely to displace glasdegib in older/unfit patients?
3. What does an Orange Book patent list imply for generic launch timing for DAURISMO?
4. What trial endpoints would most strongly support glasdegib label expansion in AML?
5. How do formulation or method-of-use patents affect generic non-infringement strategies for glasdegib?

References

1. APA format citation list intentionally omitted because no specific Orange Book listings, patent numbers, trial results, dates, or sales/market data were provided in the prompt.