CLINICAL TRIALS PROFILE FOR ADRIAMYCIN PFS

505(b)(2) Clinical Trials for ADRIAMYCIN PFS

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Dosage	NCT01760226 ↗	Dose Adjusted EPOCH-R, to Treat Mature B Cell Malignancies	Completed	National Cancer Institute (NCI)	Early Phase 1	2013-01-01	The subject is invited to take part in this research study because s/he has been diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), or Post-transplant Lymphoproliferative Disorder (PTLD). In an attempt to improve cure rates while reducing harmful effects from drugs, oncologists are developing new treatment protocols. One such protocol, entitled dose-adjusted EPOCH-R, utilizes two major new strategies. First, the treatment approach utilizes continuous infusion of chemotherapy over four days, instead of being administered over minutes or hours. Secondly, the doses of some medications involved are increased or decreased based on how the drugs affect the subject's ability to produce blood cells, which is used as a measure of how rapidly the body is processing drugs. Using this approach in adults, researchers have shown improved cure rates in these cancers. Additionally, the harmful effects experienced by patients has been mild, with mucositis, severe infections, and tumor lysis syndrome occurring rarely. However, this new dosing method has never been used in children, and the effectiveness and side effects of this new method are unknown in children. The purpose of this study is to look at the safety of dose-adjusted EPOCH-R in the treatment of children with mature B-cell cancers, and to see if we can maintain cure rates (as has been shown in adults). This study represents the first trial of dose-adjusted EPOCH-R in children.
New Dosage	NCT01760226 ↗	Dose Adjusted EPOCH-R, to Treat Mature B Cell Malignancies	Completed	Texas Children's Hospital	Early Phase 1	2013-01-01	The subject is invited to take part in this research study because s/he has been diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), or Post-transplant Lymphoproliferative Disorder (PTLD). In an attempt to improve cure rates while reducing harmful effects from drugs, oncologists are developing new treatment protocols. One such protocol, entitled dose-adjusted EPOCH-R, utilizes two major new strategies. First, the treatment approach utilizes continuous infusion of chemotherapy over four days, instead of being administered over minutes or hours. Secondly, the doses of some medications involved are increased or decreased based on how the drugs affect the subject's ability to produce blood cells, which is used as a measure of how rapidly the body is processing drugs. Using this approach in adults, researchers have shown improved cure rates in these cancers. Additionally, the harmful effects experienced by patients has been mild, with mucositis, severe infections, and tumor lysis syndrome occurring rarely. However, this new dosing method has never been used in children, and the effectiveness and side effects of this new method are unknown in children. The purpose of this study is to look at the safety of dose-adjusted EPOCH-R in the treatment of children with mature B-cell cancers, and to see if we can maintain cure rates (as has been shown in adults). This study represents the first trial of dose-adjusted EPOCH-R in children.
New Dosage	NCT01760226 ↗	Dose Adjusted EPOCH-R, to Treat Mature B Cell Malignancies	Completed	Baylor College of Medicine	Early Phase 1	2013-01-01	The subject is invited to take part in this research study because s/he has been diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), or Post-transplant Lymphoproliferative Disorder (PTLD). In an attempt to improve cure rates while reducing harmful effects from drugs, oncologists are developing new treatment protocols. One such protocol, entitled dose-adjusted EPOCH-R, utilizes two major new strategies. First, the treatment approach utilizes continuous infusion of chemotherapy over four days, instead of being administered over minutes or hours. Secondly, the doses of some medications involved are increased or decreased based on how the drugs affect the subject's ability to produce blood cells, which is used as a measure of how rapidly the body is processing drugs. Using this approach in adults, researchers have shown improved cure rates in these cancers. Additionally, the harmful effects experienced by patients has been mild, with mucositis, severe infections, and tumor lysis syndrome occurring rarely. However, this new dosing method has never been used in children, and the effectiveness and side effects of this new method are unknown in children. The purpose of this study is to look at the safety of dose-adjusted EPOCH-R in the treatment of children with mature B-cell cancers, and to see if we can maintain cure rates (as has been shown in adults). This study represents the first trial of dose-adjusted EPOCH-R in children.
OTC	NCT03742258 ↗	Combination Chemotherapy and TAK-659 as Front-Line Treatment in Treating Patients With High-Risk Diffuse Large B Cell Lymphoma	Active, not recruiting	National Cancer Institute (NCI)	Phase 1	2019-03-13	The purpose of this research study is to evaluate a new investigational drug, TAK-659, given in combination with standard chemotherapy, for the treatment of Diffuse Large B-cell Lymphoma (DLBCL). ?Investigational? means that TAK-659 has not been approved by the United States Food and Drug Administration (FDA) for use as a prescription or over-the-counter medication to treat a certain condition. The primary purpose of this study is to find the appropriate and safe dose of the study drug to be used in combination with standard chemotherapy for the treatment of your disease and to determine how well the drug works in treating the disease. Other objectives include measuring the amount of the study drug in the body at different times after taking the study drug. Participation in the study is expected to last for up to 3 years after receiving the last dose of the study drug. Patients will receive the study treatment for up to 18 weeks, as long as they are benefitting.
OTC	NCT03742258 ↗	Combination Chemotherapy and TAK-659 as Front-Line Treatment in Treating Patients With High-Risk Diffuse Large B Cell Lymphoma	Active, not recruiting	Northwestern University	Phase 1	2019-03-13	The purpose of this research study is to evaluate a new investigational drug, TAK-659, given in combination with standard chemotherapy, for the treatment of Diffuse Large B-cell Lymphoma (DLBCL). ?Investigational? means that TAK-659 has not been approved by the United States Food and Drug Administration (FDA) for use as a prescription or over-the-counter medication to treat a certain condition. The primary purpose of this study is to find the appropriate and safe dose of the study drug to be used in combination with standard chemotherapy for the treatment of your disease and to determine how well the drug works in treating the disease. Other objectives include measuring the amount of the study drug in the body at different times after taking the study drug. Participation in the study is expected to last for up to 3 years after receiving the last dose of the study drug. Patients will receive the study treatment for up to 18 weeks, as long as they are benefitting.

All Clinical Trials for ADRIAMYCIN PFS

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000681 ↗	A Phase I Study of the Combination of Recombinant GM-CSF, AZT, and Chemotherapy (ABV) (Adriamycin, Bleomycin, Vincristine) in AIDS and Kaposi's Sarcoma	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To determine the safety as well as the most effective dose of sargramostim (GM-CSF; granulocyte-macrophage colony stimulating factor) that will prevent the side effects caused by the combined use of zidovudine (AZT) and various doses of cancer-fighting drugs (doxorubicin, bleomycin, and vincristine) in AIDS patients with Kaposi's sarcoma (KS). Patients included in this study have KS, which is a type of cancer that occurs in nearly 20 percent of patients with AIDS. AIDS patients with extensive KS require treatment with effective cytotoxic (anti-cancer) agents to reduce the tumor size and with antiretroviral agents such as AZT to prevent or ameliorate the development of opportunistic infections. Due to the significant toxic effect of both cytotoxic and antiviral agents on the bone marrow where new blood cells are generated, the combination of these agents is expected to result in complications such as granulocytopenia (very low granulocyte counts). Hematopoietic growth factors such as GM-CSF may reduce the severity and duration of marrow suppression. This may improve survival. Clinical trials of GM-CSF in HIV infected individuals with or without granulocytopenia have shown that the progenitor cells (early blood cells) are responsive to GM-CSF.
NCT00000954 ↗	A Study of Chemotherapy Plus ddI or ddC in the Treatment of AIDS-Related Kaposi's Sarcoma	Completed	Bristol-Myers Squibb	Phase 1	1969-12-31	To determine the toxicity and response to treatment with cytotoxic chemotherapy using doxorubicin (Adriamycin), bleomycin, and vincristine (DBV) for advanced AIDS-related Kaposi's sarcoma in combination with either didanosine (ddI) or zalcitabine (dideoxycytidine; ddC). AIDS patients with extensive Kaposi's sarcoma require treatment with effective cytotoxic agents to reduce the tumor burden, and they also require treatment with other possibly effective antiretroviral agents such as ddI or ddC to ameliorate (delay) the development of opportunistic infections.
NCT00000954 ↗	A Study of Chemotherapy Plus ddI or ddC in the Treatment of AIDS-Related Kaposi's Sarcoma	Completed	Novum	Phase 1	1969-12-31	To determine the toxicity and response to treatment with cytotoxic chemotherapy using doxorubicin (Adriamycin), bleomycin, and vincristine (DBV) for advanced AIDS-related Kaposi's sarcoma in combination with either didanosine (ddI) or zalcitabine (dideoxycytidine; ddC). AIDS patients with extensive Kaposi's sarcoma require treatment with effective cytotoxic agents to reduce the tumor burden, and they also require treatment with other possibly effective antiretroviral agents such as ddI or ddC to ameliorate (delay) the development of opportunistic infections.
NCT00000954 ↗	A Study of Chemotherapy Plus ddI or ddC in the Treatment of AIDS-Related Kaposi's Sarcoma	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To determine the toxicity and response to treatment with cytotoxic chemotherapy using doxorubicin (Adriamycin), bleomycin, and vincristine (DBV) for advanced AIDS-related Kaposi's sarcoma in combination with either didanosine (ddI) or zalcitabine (dideoxycytidine; ddC). AIDS patients with extensive Kaposi's sarcoma require treatment with effective cytotoxic agents to reduce the tumor burden, and they also require treatment with other possibly effective antiretroviral agents such as ddI or ddC to ameliorate (delay) the development of opportunistic infections.
NCT00000987 ↗	A Study of Chemotherapy Plus Azidothymidine in the Treatment of Kaposi's Sarcoma in Patients With AIDS	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To study the safety and maximum tolerated dose (MTD) of combined chemotherapy when it is administered to patients with advanced Kaposi's sarcoma together with one of two different doses of zidovudine (AZT). The combination of AZT and chemotherapy may be effective in treating the tumor as well as preventing the life-threatening infections when used for patients with AIDS and Kaposi's sarcoma. The MTD of combined chemotherapy is being determined so that the information will be available for future studies, when the relative effectiveness of the two doses of AZT has been learned.
NCT00001165 ↗	Combination Chemotherapy in Patients With Zollinger-Ellison Syndrome and Tumors of the Pancreas	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2	1978-09-01	Patients with Zollinger-Ellison Syndrome suffer from ulcers of the upper gastrointestinal tract, higher than normal levels of gastric acid, and tumors of the pancreas known as non-beta islet cell tumors. Prior to the use of drugs to cure the ulcers, patients typically died due to severe ulcers. Because of such effective drugs to treat the ulcers it is more common to see patients dying due to the pancreatic tumors. The study will observe patients suffering from Zollinger-Ellison Syndrome and non-beta islet cell tumors and determine the effectiveness of combined chemotherapy with streptozotocin, 5-fluorouracil, and doxorubicin.

Clinical Trial Conditions for ADRIAMYCIN PFS

Condition Name

Condition Name for ADRIAMYCIN PFS
Intervention	Trials
Breast Cancer	85
Lymphoma	30
Sarcoma	27
Multiple Myeloma	26

Condition MeSH

Condition MeSH for ADRIAMYCIN PFS
Intervention	Trials
Lymphoma	154
Breast Neoplasms	127
Hodgkin Disease	58
Sarcoma	58

Clinical Trial Locations for ADRIAMYCIN PFS

Trials by Country

Trials by Country for ADRIAMYCIN PFS
Location	Trials
Canada	342
Spain	70
Italy	64
Puerto Rico	39
China	37

Trials by US State

Trials by US State for ADRIAMYCIN PFS
Location	Trials
Texas	165
New York	130
California	128
Illinois	113
Ohio	106

Clinical Trial Progress for ADRIAMYCIN PFS

Clinical Trial Phase

Clinical Trial Phase for ADRIAMYCIN PFS
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	1
PHASE2	9

Clinical Trial Status

Clinical Trial Status for ADRIAMYCIN PFS
Clinical Trial Phase	Trials
Completed	248
Recruiting	85
Active, not recruiting	82

Clinical Trial Sponsors for ADRIAMYCIN PFS

Sponsor Name

Sponsor Name for ADRIAMYCIN PFS
Sponsor	Trials
National Cancer Institute (NCI)	184
M.D. Anderson Cancer Center	51
Children's Oncology Group	35

Sponsor Type

Sponsor Type for ADRIAMYCIN PFS
Sponsor	Trials
Other	635
Industry	202
NIH	193

Adriamycin PFS (Doxorubicin HCl) — Clinical Trials Update, Market Analysis, and Projection

Last updated: May 3, 2026

What is Adriamycin PFS and what is its development status?

Adriamycin PFS is a ready-to-use presentation (PFS = prefilled syringe) of doxorubicin hydrochloride, a cytotoxic anthracycline used across multiple oncology indications. Its clinical and regulatory standing is shaped by the long-established role of doxorubicin in standard-of-care regimens rather than by ongoing, brand-new mechanism-of-action development.

As of the latest publicly indexed trial landscape, clinical activity remains dominated by:

• New formulation and product-resupply strategies tied to supply continuity for an older, widely used active ingredient.
• Combination regimens where doxorubicin is incorporated as a backbone component.
• Supportive trials, comparative studies, and post-approval or translational work where doxorubicin is part of an investigational protocol.

Key point for investors and R&D planners: the “Adriamycin PFS” product positioning typically depends less on de novo efficacy trials and more on manufacturing, labeling differentiation, and sustained supply into existing chemotherapy standards. That makes the commercial trajectory more sensitive to competitive supply dynamics, payer coverage, and procurement behavior than to breakthrough clinical readouts.

Which clinical trials currently include doxorubicin (and what does that imply for Adriamycin PFS)?

Public clinical-trial registries do not consistently isolate “Adriamycin PFS” as a named investigational product across protocols. Instead, protocols usually reference doxorubicin (or doxorubicin formulations) generically. The actionable signal is therefore whether ongoing trials continue to use doxorubicin as the active backbone in active recruitment or active follow-up phases.

Active clinical-trial signals (high level)

Clinical trials in oncology that include doxorubicin typically fall into these bins:

1. Breast cancer combination settings (neoadjuvant/adjuvant frameworks; regimen substitutions and schedules)
2. Lymphomas and solid tumors where doxorubicin is a standard component
3. Therapy optimization where the drug is a comparator arm or a backbone in a multi-agent regimen

Implications for “PFS” commercialization

• If protocols use doxorubicin broadly without specifying a particular branded formulation, market share accrues at the procurement level (hospital formularies, group purchasing organization contracts, wholesaler availability) rather than at the trial-selection level.
• PFS convenience can influence uptake in settings that value administration workflow and inventory handling, but it does not typically change clinical efficacy outcomes in registration-defining trials.

What is the market reality for doxorubicin and how does that translate to Adriamycin PFS?

Doxorubicin is a mature oncology drug with extensive generic penetration worldwide. Brand-level market outcomes for an “Adriamycin” presentation are shaped by:

• Tender and contract awards at hospital and health-system level
• Short-term supply and manufacturing uptime
• Dose-vial economics (including waste factors)
• Institutional preference for ready-to-use formats versus traditional vial handling
• Competitive displacement by low-cost generics and alternative anthracyclines in some pathways

Demand drivers

• Persistent chemotherapy use across indications
• Regimen entrenchment in combination schedules where anthracyclines remain standard
• Ongoing clinical use in both early-stage and advanced oncology settings

Constraint drivers

• Patent/market exclusivity effects are limited due to maturity of the molecule
• Price compression due to multiple generic suppliers
• Safety and administration handling costs (risk controls, infusion workflow)
• Competition from liposomal doxorubicin formulations in selected settings, where payers may steer by tolerability and administration considerations

How big is the doxorubicin opportunity and what is the realistic revenue capture model for Adriamycin PFS?

For mature molecules, revenue capture is best modeled as:

• Share of procurement for doxorubicin within anthracycline regimens
• Share of shelf supply for the specific presentation (PFS vs vial)
• Net pricing after contracting and rebates
• Utilization stability driven by guideline persistence rather than new label expansion

Practical projection framework (for a PFS presentation)

A PFS product typically competes on:

• Handling time reduction in infusion centers
• Reduced preparation steps and potential reduction in administration errors
• Workflow compatibility with oncology pharmacy operations
• Improved shelf reliability versus fragmented small-batch suppliers

Where generics undercut price, uptake depends on whether procurement departments accept PFS value. In many systems, PFS can still win if it reduces operational friction and procurement complexity or if contract structures bundle branded supplies.

What are the key commercial metrics to track for projection accuracy?

For Adriamycin PFS, track these operational KPIs:

• Hospital purchasing wins (contract awards, GPO placement)
• Formulary placement (tiering and PA rules, if any)
• Channel inventory stability (backorders and allocation periods)
• Net price trends (rebate and contract pricing, not list price)
• Switching behavior after generic tender renewals
• Therapy mix changes that shift anthracycline use across tumor types

What is the clinical-trials-to-sales link for this product?

Because doxorubicin is mature, trials rarely create step-change demand for the molecule. The sales link is indirect:

• Trials can influence regimen selection (e.g., when doxorubicin is preferred or deprioritized in favor of non-anthracycline backbones).
• Trials can influence schedule and dosing intensity, altering units consumed.
• Trials that stress toxicity management can push shifts between conventional doxorubicin and alternative anthracyclines (including liposomal variants).

For Adriamycin PFS specifically, the trial impact is usually secondary to procurement outcomes.

How should you project market share for Adriamycin PFS over 3 to 5 years?

A reasonable projection approach for a mature anthracycline brand/presentation uses a bounded competitive model:

1) Base case (contract-driven stability)

• Share stays stable to modestly down unless a tender cycle forces switching
• PFS value helps retain institutions with strong workflow preference
• Generic competition continues but does not eliminate all branded procurement

2) Downside case (tender-driven displacement)

• Increased generic consolidation or aggressive price offers
• Payers and procurement committees favor lowest net cost
• PFS loses contracts and de-emphasizes in formularies

3) Upside case (supply and workflow premium)

• Supply reliability differentiates PFS through backorder-avoidance
• Pharmacy preference for ready-to-use reduces preparation burden
• Contract bundling favors the PFS product

Year-by-year projection mechanics

Use doxorubicin utilization as the denominator and apply:

• Net revenue per unit for PFS under each contract tier
• Unit volume changes tied to regimen mix and dose intensity shifts
• A switching probability per contract renewal window

What risks and opportunities matter most to investors?

Risks

• Generic price erosion reduces net revenue per dose
• Formulary tiering risk in competitive tender cycles
• Supply allocation events that affect institutional ordering patterns
• Regimen shift risk if anthracycline use declines in certain pathways due to emerging standards

Opportunities

• Operational workflow advantage for PFS in high-throughput infusion centers
• Contract resilience if health systems prefer ready-to-use products
• Institution-specific preference where pharmacies standardize on PFS handling

What to watch next in the clinical pipeline

Even though doxorubicin is mature, trial activity remains relevant as a demand driver for “doxorubicin-containing regimens.” Monitor:

• Active recruitment and results publication for studies where doxorubicin is a backbone component
• Comparative regimen studies that keep doxorubicin in the recommended pathway
• Trials that change schedules or dose intensities (units consumed)
• Trials that validate toxicity management where anthracycline use persists

Key Takeaways

• Adriamycin PFS is positioned around a mature, widely used oncology backbone (doxorubicin). Clinical trial impact typically does not create brand-new demand; it influences regimen selection and dosing intensity.
• Market outcomes for Adriamycin PFS are procurement-led: hospital contracting, formulary tiering, supply reliability, and net pricing drive share.
• For projection, model revenue as share-of-procurement times net pricing under contract tiers, with switching events tied to tender cycles.
• The near-term upside and downside are most sensitive to generic price pressure and institutional acceptance of PFS workflow value.

FAQs

1) Is Adriamycin PFS tied to new clinical efficacy evidence?
Typically no. The molecule is mature; commercial differentiation more often reflects product presentation, supply continuity, and procurement contracting than new efficacy registration.

2) Do ongoing clinical trials increase doxorubicin demand automatically?
Not automatically. Trials can reinforce or alter regimen selection, but most demand change comes through guideline and procurement adoption rather than trial publication alone.

3) What most directly determines Adriamycin PFS revenue?
Net pricing after contracting plus units purchased in doxorubicin-containing regimens, with share shaped by tender and formulary cycles.

4) How should you forecast units for a mature oncology drug like doxorubicin?
Use regimen-level utilization trends (tumor mix and scheduling) and apply contract-based switching probabilities across institutions.

5) What is the primary competitive threat to Adriamycin PFS?
Low-cost generic doxorubicin offerings and, in some settings, substitution with alternative anthracycline formulations that payers may steer to based on tolerability and handling preferences.

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References

[1] ClinicalTrials.gov. Doxorubicin (search results and trial records). U.S. National Library of Medicine. https://clinicaltrials.gov/
[2] National Cancer Institute. Doxorubicin (drug information, overview). https://www.cancer.gov/