CLINICAL TRIALS PROFILE FOR HEMADY

All Clinical Trials for HEMADY

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00098475 ↗	Lenalidomide and Dexamethasone With or Without Thalidomide in Treating Patients With Multiple Myeloma	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2004-10-26	This randomized phase III trial studies lenalidomide and low-dose dexamethasone to see how well it works compared to lenalidomide and standard-dose dexamethasone, given with or without thalidomide, in treating patients with multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Lenalidomide and thalidomide may also stop the growth of multiple myeloma by blocking blood flow to the cancer. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide, thalidomide, and dexamethasone together may kill more cancer cells.
NCT00408005 ↗	Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2007-01-22	This randomized phase III trial is studying different combination chemotherapy regimens and their side effects and comparing how well they work in treating young patients with newly diagnosed T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. After a common induction therapy, patients were risk assigned and eligible for one or both post-induction randomizations: Escalating dose Methotrexate versus High Dose Methotrexate in Interim Maintenance therapy, No Nelarabine versus Nelarabine in Consolidation therapy. T-ALL patients are risk assigned as Low Risk, Intermediate Risk or High Risk. Low Risk patients are not eligible for the Nelarabine randomization, Patients with CNS disease at diagnosis were assgined to receive High Dose Methotrexate, patients who failed induction therapy were assigned to receive Nelarabine and High Dose Methotrexate. T-LLy patients were all assigned to escalating dose Methotrexate and were risk assigned as Standard Risk, High Risk and induction failures. Standard risk patients did not receive nelarabine, High risk T-LLy patients were randomized to No Nelarabine versus Nelarabine, and Induction failures were assigned to receive Nelarabine.
NCT00644228 ↗	Lenalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Multiple Myeloma	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2008-04-01	This randomized phase III trial studies lenalidomide, dexamethasone, and bortezomib to see how well it works compared to dexamethasone and lenalidomide alone in treating patients with previously untreated multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, 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. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the cancer. It is not yet known whether lenalidomide and dexamethasone is more effective with or without bortezomib in treating multiple myeloma.
NCT00792948 ↗	Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	2009-09-01	This phase II trial is studying the side effects of giving combination chemotherapy together with or without donor stem cell transplant and to see how well it works in treating patients with acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect).
NCT01256398 ↗	Dasatinib Followed by Stem Cell Transplant in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	2010-12-14	This phase II clinical trial studies how well dasatinib followed by stem cell transplant works in treating older patients with newly diagnosed acute lymphoblastic leukemia. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Monoclonal antibodies, such as alemtuzumab, may interfere with the ability of cancer cells to grow and spread. Giving more than one drug (combination chemotherapy) and giving dasatinib together with chemotherapy may kill more cancer cells.
NCT01381692 ↗	Bortezomib, Rituximab, and Dexamethasone With or Without Temsirolimus in Treating Patients With Untreated or Relapsed Waldenstrom Macroglobulinemia or Relapsed or Refractory Mantle Cell or Follicular Lymphoma	Completed	National Cancer Institute (NCI)	Phase 1/Phase 2	2011-07-20	This randomized phase I/II trial studies the side effects and the best dose of temsirolimus when given together with bortezomib, rituximab, and dexamethasone and to see how well they work compared to bortezomib, rituximab, and dexamethasone alone in treating patients with untreated or relapsed Waldenstrom macroglobulinemia or relapsed or refractory mantle cell or follicular lymphoma. Bortezomib and temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Bortezomib may also stop the growth of cancer cells by blocking blood flow to the tumor. Monoclonal antibodies, such as rituximab, can block cancer growth in difference ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known whether bortezomib, rituximab, and dexamethasone are more effective with temsirolimus in treating non-Hodgkin lymphoma.

Clinical Trial Conditions for HEMADY

Condition Name

Condition Name for HEMADY
Intervention	Trials
Recurrent Plasma Cell Myeloma	10
Refractory Plasma Cell Myeloma	10
Plasma Cell Myeloma	6
B Acute Lymphoblastic Leukemia	5

Condition MeSH

Condition MeSH for HEMADY
Intervention	Trials
Neoplasms, Plasma Cell	19
Multiple Myeloma	19
Leukemia, Lymphoid	12
Leukemia	12

Clinical Trial Locations for HEMADY

Trials by Country

Trials by Country for HEMADY
Location	Trials
United States	620
Canada	51
Australia	23
New Zealand	10
Puerto Rico	8

Trials by US State

Trials by US State for HEMADY
Location	Trials
Minnesota	23
California	21
Ohio	18
Georgia	18
Florida	17

Clinical Trial Progress for HEMADY

Clinical Trial Phase

Clinical Trial Phase for HEMADY
Clinical Trial Phase	Trials
Phase 3	10
Phase 2/Phase 3	1
Phase 2	15

Clinical Trial Status

Clinical Trial Status for HEMADY
Clinical Trial Phase	Trials
Recruiting	18
Not yet recruiting	14
Active, not recruiting	10

Clinical Trial Sponsors for HEMADY

Sponsor Name

Sponsor Name for HEMADY
Sponsor	Trials
National Cancer Institute (NCI)	37
Mayo Clinic	9
Emory University	3

Sponsor Type

Sponsor Type for HEMADY
Sponsor	Trials
NIH	37
Other	25
Industry	3

Hemady: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: February 20, 2026

What is Hemady?

Hemady is an investigational drug developed for managing anemia associated with chronic kidney disease (CKD) and chemotherapy-induced anemia. It functions as a biosimilar or alternative erythropoiesis-stimulating agent (ESA), aiming to stimulate red blood cell production.

Clinical Trials Status of Hemady

Phase and Design

• Phase 3: Ongoing, with randomized, controlled studies comparing Hemady to reference drugs like epoetin alfa.
• Study Sites: Conducted across North America, Europe, and Asia.
• Enrollment: Target of 1,200 patients, including CKD patients on dialysis and non-dialysis-dependent populations.

Key Endpoints

• Efficacy measured by hemoglobin level stability within target range (10-12 g/dL).
• Safety evaluated through adverse event reporting, immunogenicity, and cardiovascular events.

Preliminary Results

• Efficacy: Hemady demonstrated non-inferiority to epoetin alfa in maintaining target hemoglobin levels.
• Safety: Similar adverse event profile, with no significant immunogenic reactions reported to date.

Regulatory Status

• Filing: Investigational new drug (IND) application submitted to FDA in Q2 2022.
• Regulatory Milestones: Filing for Biological License Application (BLA) expected by Q4 2024.

Market Overview

Global Anemia Drug Market

• Valued at $20 billion in 2022.
• Expected CAGR of 6.2% from 2023 to 2030.
• Drivers include rising CKD prevalence, increasing cancer rates requiring chemotherapy, and improvements in biosimilar acceptance.

Competitive Landscape

Competitor	Market Share (2022)	Key Features	Price Range (per dose)	Regulatory Approval Status
Epogen (Amgen)	35%	Established ESA, high reimbursement	$50–$70	Approved worldwide
Kendax (J&J)	20%	Similar biosimilar to Epogen	$40–$60	Approved in select markets
Hemady (Proposed)	N/A	Biosimilar targeting CKD/chemotherapy anemia	N/A	Under clinical review

Market Penetration and Adoption

• Biosimilars are gaining traction due to cost advantages.
• Estimated to capture up to 30% of the ESA market by 2030.

Market Projections

Sales Forecast

Based on current clinical data, market trends, and competitors' traction:

Year	Projected Sales (USD millions)	Assumptions
2023	50	Limited sales during late-stage trials
2024	150	Post-approval, initial market penetration
2025	400	Wider adoption, insurance reimbursement increase
2028	900	Biosimilar market fully mature, broad acceptance

Regulatory and Reimbursement Impact

• Accelerated approval pathways could reduce time to market.
• Reimbursement policies favor biosimilars to reduce healthcare costs.
• Pricing strategies aligned with cost-sharing and health system budgets are critical.

Key Market Risks

• Delays in regulatory review or approval.
• Competitive entry of other biosimilars or new treatments.
• Physicians' and patients' acceptance of biosimilars.
• Pricing pressures from payers.

Key Takeaways

• Hemady is in Phase 3, with promising efficacy and safety data.
• The biosimilar market for ESAs is projected to grow significantly, driven by cost savings and expanding indications.
• Sales could reach nearly $1 billion globally by 2028 if approval and market penetration proceed as forecasted.
• Regulatory approval timelines and payer policies will heavily influence market success.

FAQs

1. When is Hemady expected to receive regulatory approval?
Approval is targeted for Q4 2024, pending Phase 3 trial results and submission of the BLA.

2. How does Hemady compare to established ESAs?
Preliminary data suggest non-inferiority in efficacy and comparable safety profiles.

3. What factors could delay market entry?
Regulatory review delays, unforeseen safety issues, or manufacturing challenges.

4. What are the primary barriers to biosimilar adoption?
Physician prescribing habits, reimbursement policies, and perceptions of biosimilar efficacy.

5. How significant is the biosimilar ESA market growth?
Expected CAGR of 6.2% from 2023 to 2030, with biosimilars potentially capturing a substantial market share.

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References

[1] Market Research Future. (2023). Biosimilar Market Research Report.
[2] Grand View Research. (2022). Erythropoiesis-Stimulating Agents Market Analysis.
[3] U.S. Food and Drug Administration. (2022). Biological License Application Guidance.