CLINICAL TRIALS PROFILE FOR ALDESLEUKIN

All Clinical Trials for aldesleukin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000680 ↗	A Phase I Study of Autologous, Activated CD8(+) Lymphocytes Expanded In Vitro and Infused With or Without Recombinant Interleukin-2 to Patients With AIDS or Severe ARC	Completed	Applied Immunesciences	Phase 1	1969-12-31	1) To determine whether it is possible to remove and culture (increase in number and activate) in the laboratory, CD8(+) lymphocytes (white blood cells) from HIV-infected patients receiving zidovudine (AZT); 2) To determine the toxicity of returning to the patients intravenously the expanded and activated autologous cells (given to the patient from whom they were taken), with and without giving the patients recombinant interleukin-2 ( aldesleukin; IL-2 ) at the same time; 3) To radiolabel (mark) the CD8(+) lymphocytes with Indium 111, and then scan the patients to determine the distribution of the CD8(+) lymphocytes in those who are and are not given IL-2 infusions; 4) To determine the toxicity of IL-2 given at the same time with autologous CD8(+) lymphocytes; 5) To measure changes in the immunology of the subjects following these treatments. CD8(+) cells are suppressor/killer lymphocyte cells that act to limit replication of viruses. It is hoped that the reinfusion of activated autologous CD8(+) cells into patients with AIDS will help to control opportunistic infections such as cytomegalovirus and toxoplasmosis (two of the leading causes of sickness and death in AIDS patients). This treatment may also stop the HIV virus from replicating (reproducing itself) in the AIDS patient. Further activation of these cells, once infused, may be necessary. It is hoped that IL-2 will stimulate the patient's immune system against the AIDS virus along with the activated CD8(+) cells. Thus, IL-2 will be given, and its effects studied.
NCT00000680 ↗	A Phase I Study of Autologous, Activated CD8(+) Lymphocytes Expanded In Vitro and Infused With or Without Recombinant Interleukin-2 to Patients With AIDS or Severe ARC	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	1) To determine whether it is possible to remove and culture (increase in number and activate) in the laboratory, CD8(+) lymphocytes (white blood cells) from HIV-infected patients receiving zidovudine (AZT); 2) To determine the toxicity of returning to the patients intravenously the expanded and activated autologous cells (given to the patient from whom they were taken), with and without giving the patients recombinant interleukin-2 ( aldesleukin; IL-2 ) at the same time; 3) To radiolabel (mark) the CD8(+) lymphocytes with Indium 111, and then scan the patients to determine the distribution of the CD8(+) lymphocytes in those who are and are not given IL-2 infusions; 4) To determine the toxicity of IL-2 given at the same time with autologous CD8(+) lymphocytes; 5) To measure changes in the immunology of the subjects following these treatments. CD8(+) cells are suppressor/killer lymphocyte cells that act to limit replication of viruses. It is hoped that the reinfusion of activated autologous CD8(+) cells into patients with AIDS will help to control opportunistic infections such as cytomegalovirus and toxoplasmosis (two of the leading causes of sickness and death in AIDS patients). This treatment may also stop the HIV virus from replicating (reproducing itself) in the AIDS patient. Further activation of these cells, once infused, may be necessary. It is hoped that IL-2 will stimulate the patient's immune system against the AIDS virus along with the activated CD8(+) cells. Thus, IL-2 will be given, and its effects studied.
NCT00000728 ↗	Phase I Trial of the Combination of Zidovudine and Recombinant Interleukin-2 in Patients With Persistent Generalized Lymphadenopathy	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To evaluate the short-term effects of administering zidovudine ( AZT ) at the same time with increasing doses of aldesleukin ( interleukin-2; IL-2 ) in patients with persistent generalized lymphadenopathy syndrome ( PGL ). The effects to be studied include safety or toxicity, how quickly the drugs are used in the body, effects on the immune system, effects on HIV, concentrations in body fluids, and how quickly the drugs are cleared by the kidneys. The trial will establish the maximum tolerated dose ( MTD ) and will be a pilot study to determine the dose that has the greatest effect in the immune system. AZT has been shown to be effective in HIV-related disease. IL-2 has been shown to increase immune responses and correct immune problems caused by HIV in the test tube. IL-2 has also been effective in treating Kaposi's sarcoma in a number of patients. Because of the clinical activities of these two drugs and because their toxicities and mechanisms of action do not overlap, it may be beneficial to combine the two drugs with their antiviral and immune stimulatory effects.
NCT00000820 ↗	A Phase II Study of Low-Dose Interleukin-2 by Subcutaneous Injection in Combination With Antiretroviral Therapy Versus Antiretroviral Therapy Alone in Patients With HIV-1 Infection and at Least 3 Months Stable Antiretroviral Therapy	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	PRIMARY: To examine the effect of aldesleukin ( IL-2 ) on viral activity in the blood. To determine the safety of low-dose IL-2 in combination with antiretroviral therapy versus antiretroviral therapy alone. SECONDARY: To examine delayed type hypersensitivity responses to skin test antigens and antibody responses to protein and polysaccharide vaccines. The profound immune impairment that results from HIV-1 infection is due, at least in part, to the loss of CD4+ T cells and the cytokines these cells secrete, especially IL-2 and interferon-gamma. Antiretroviral agents do not directly address the problem of immune impairment. Replacement of IL-2 at nontoxic doses may prevent or delay clinical immunosuppression and its attendant opportunistic infections. Also, since patients with HIV-1 infection respond suboptimally to routine protein and polysaccharide immunizations, IL-2 may provide an adjuvant effect on vaccine responses.
NCT00000821 ↗	Subcutaneously Administered Aldesleukin ( Interleukin-2; IL-2 ) Therapy in HIV-Infected Patients	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To compare the effects of low-dose versus high-dose subcutaneous ( SC ) aldesleukin ( interleukin-2; IL-2 ) on immunologic and virologic markers in HIV-infected patients. To compare the effects of monthly versus bimonthly administration of SC IL-2 on these markers. Interleukin-2 is a protein that is naturally produced by lymphocytes. In an initial study, patients in an earlier stage of HIV-1 infection tended to tolerate SC IL-2 better than those with more advanced infections, and those with higher baseline CD4+ counts tended to derive the greatest benefit.
NCT00000825 ↗	The Effects of Giving Interleukin-2 (IL-2) Plus Anti-HIV Therapy to HIV-Positive Patients With CD4 Cell Counts of at Least 350 Cells/mm3	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1998-05-01	The purpose of this study is to evaluate the safety and tolerability of giving IL-2 plus anti-HIV (antiretroviral) therapy to HIV-positive patients with CD4 cell counts (cells of the immune system that fight infection) of at least 350 cells/mm3. This study will also examine the ability of antiretroviral therapy combined with IL-2 to boost the immune system. IL-2, given through injection under the skin, in combination with anti-HIV therapy can increase CD4 cell counts. This study examines 3 doses of IL-2 in order to determine the safest and most effective dose to use.

Clinical Trial Conditions for aldesleukin

Condition Name

Condition Name for aldesleukin
Intervention	Trials
HIV Infections	32
Metastatic Melanoma	31
Melanoma	23
Melanoma (Skin)	20

Condition MeSH

Condition MeSH for aldesleukin
Intervention	Trials
Melanoma	82
HIV Infections	33
Carcinoma, Renal Cell	32
Leukemia	29

Clinical Trial Locations for aldesleukin

Trials by Country

Trials by Country for aldesleukin
Location	Trials
United States	709
Canada	30
Australia	30
United Kingdom	23
France	10

Trials by US State

Trials by US State for aldesleukin
Location	Trials
Maryland	86
California	52
Texas	45
New York	40
Washington	30

Clinical Trial Progress for aldesleukin

Clinical Trial Phase

Clinical Trial Phase for aldesleukin
Clinical Trial Phase	Trials
PHASE2	1
PHASE1	11
Phase 4	4

Clinical Trial Status

Clinical Trial Status for aldesleukin
Clinical Trial Phase	Trials
Completed	133
Terminated	47
Recruiting	32

Clinical Trial Sponsors for aldesleukin

Sponsor Name

Sponsor Name for aldesleukin
Sponsor	Trials
National Cancer Institute (NCI)	150
National Institute of Allergy and Infectious Diseases (NIAID)	29
Fred Hutchinson Cancer Research Center	21

Sponsor Type

Sponsor Type for aldesleukin
Sponsor	Trials
Other	265
NIH	193
Industry	72

Aldesleukin (Proleukin) Clinical Trials Update, Market Analysis, and Sales Projection (2024–2035)

Last updated: July 28, 2026

Aldesleukin is an approved interleukin-2 (IL-2) recombinant therapy (Proleukin) with a shrinking, niche market tied to specific oncology indications. Current clinical activity and future revenue potential are limited by aging market incumbency, reduced payer preference for high-toxicity cytokine therapy, and high entry barriers for competing biologics. Market demand is concentrated in select centers and patient subpopulations, with most measurable growth scenarios tied to label expansion via combination regimens rather than a broad switch from checkpoint inhibitor–dominant practice.

What is Aldesleukin used for, and what do recent clinical trials show?

Aldesleukin (recombinant IL-2) is FDA-approved for:

• Metastatic renal cell carcinoma (mRCC) (in specific patient populations)
• Metastatic melanoma (historically as first-line in select settings and in systemic disease after prior therapy, depending on clinical context)

What recent trials and updated clinical evidence focus on

Recent trial activity for IL-2 class therapies has shifted toward:

• Combination approaches with immune checkpoint inhibitors and/or other immune-modulating agents to improve response rates and durability versus IL-2 monotherapy
• Dosing optimization to reduce toxicity while maintaining immunologic activity

Clinical-trial implications: the evidence base is increasingly driven by combination immunotherapy paradigms rather than new IL-2 monotherapy trials, which constrains market growth to incremental uptake in combination regimens.

Which endpoints matter for payer adoption

For cytokine therapies, payer and guideline adoption is tied to:

• Overall response rate and durable response duration versus standard-of-care immunotherapy
• Toxicity profile and hospitalization rates (IL-2 toxicity remains a principal commercial friction point)
• Treatment setting feasibility (ICU-level monitoring has historically limited utilization outside high-expertise centers)

How many ongoing or recently completed trials include Aldesleukin?

No complete trial registry snapshot can be produced from the information provided in this chat. A defensible count requires current trial identifiers (NCT numbers), sponsors, status, and indication mapping, which cannot be reliably reconstructed here without a source feed.

Which Aldesleukin clinical trials are most likely to affect future market share?

The highest market-impact trials are those that:

• Demonstrate statistically meaningful survival or durable response outcomes in head-to-head or strong randomized comparisons against immunotherapy standards
• Target previously under-treated molecular or clinical subsets (for example, patients with features linked to IL-2 responsiveness)
• Deliver lower toxicity via regimen changes that reduce ICU utilization

In the IL-2 space, trial designs that improve tolerability while preserving efficacy are the most commercially relevant.

What patents protect Aldesleukin, and how strong is the patent estate?

Aldesleukin is an older biologic. The patent landscape for older recombinant biologics typically consists of:

• Process and formulation improvements
• Secondary compositions or dosing/regimen patents
• Method-of-use claims for specific combinations or patient selections

A reliable, litigation-grade patent map requires current Orange Book and/or Purple Book listings, USPTO family data, and claim-level status. That full set of documents is not available in this chat.

When does Aldesleukin lose exclusivity in the US, and are there any new exclusivity barriers?

Because Aldesleukin is an established product with long market history, commercial exclusivity is usually governed by:

• Expired primary composition and manufacturing patents (common for older biologics)
• Potential remaining protection for specific manufacturing processes or labeled regimen claims, if still active
• Regulatory exclusivities tied to new indications (if any) that are not guaranteed

A timeline with specific dates requires the Orange Book/biologics exclusivity record and patent-by-patent expiration mapping, which is not present here.

What is the Orange Book status of Aldesleukin, and what does it imply for generics or biosimilars?

Aldesleukin is regulated as a biologic, so Purple Book status is the key reference for biologic exclusivity and patent listings. A defensible Orange Book/Purple Book status summary requires the exact reference product entry and listed patents, none of which are included in this chat.

How does Aldesleukin compare with IL-2 competitors and alternative immunotherapies?

Competitive reality: IL-2 competes with:

• Checkpoint inhibitor combinations (PD-1/PD-L1 and CTLA-4)
• Other immuno-oncology modalities (often with better tolerability and easier outpatient workflows)

This matters commercially because:

• Even when IL-2 shows durable responses in a subset, uptake is limited by toxicity and the availability of safer regimens
• Most market expansion in oncology shifts toward therapies that reduce monitoring burden and increase convenience

Who are the key manufacturers and what is the current competitive landscape?

A market analysis requires current:

• NDA/BLA reference product and authorized manufacturers
• Whether there are authorized generics or biosimilars
• Contract manufacturing and distribution status

Those product-level facts are not provided in this chat, so a credible list of companies and market shares cannot be produced.

What market segments drive Aldesleukin demand, and how concentrated is it?

The practical demand drivers are:

• Academic and high-volume community oncology sites with experience in IL-2 administration
• Patient segments where clinicians still consider IL-2-based strategies despite checkpoint inhibitor standard-of-care
• Lines of therapy where IL-2 is used due to clinical context and access to combination protocols

Demand is typically concentrated rather than broad-based.

How big is the Aldesleukin market, and what sales projection is realistic (2024–2035)?

A defensible sales model requires baseline historical sales, net price assumptions, expected utilization trends, and competitor impact. None of these quantitative inputs are present in this chat, so a precise projection table cannot be produced without risking incorrect business conclusions.

What reimbursement and payer dynamics affect Aldesleukin pricing and utilization?

For high-toxicity biologics, the key payer levers are:

• Prior authorization and coverage policies linked to treatment setting
• Step therapy rules triggered by checkpoint inhibitor sequencing
• Site-of-care and infusion center constraints

These dynamics typically cap volume growth even when clinical outcomes are favorable in selected patients.

What biosimilar risk exists for Aldesleukin?

Biosimilar risk depends on:

• Remaining regulatory and patent barriers
• Manufacturing complexity
• Whether any “exclusivity cliffs” or patent losses are approaching

A credible biosimilar risk assessment requires:

• Purple Book listed patents and expiry windows
• Litigation or settlement history
• Biosimilar development programs by candidate manufacturers

No such record is included in this chat.

Which formulation and method-of-use patents could block incremental entry?

IL-2 product differentiation commonly comes from:

• Formulation stability, surfactant systems, and lyophilized versus liquid presentation
• Dosing schedule regimens that improve tolerability or immunologic effect
• Combination method-of-use claims

A claim-level block map cannot be generated here without patent documents and legal status.

What generic launch scenarios exist for Aldesleukin, and how likely are they?

Because Aldesleukin is a biologic, “generic” is not the normal market mechanism; the relevant scenario is biosimilar or authorized biologic competition. Launch scenarios depend on:

• Patent status for the specific reference product
• Exclusivity expiration dates
• FDA licensure pathway viability and analytics comparability package

Those facts are not provided.

What patent litigation affects Aldesleukin, and where are the flashpoints?

Patent litigation requires:

• Case captions
• Forum (DDC, Fed Cir, district)
• Filing dates, stay status, settlements, and claim rulings

No litigation record is present in this chat, so a litigation-driven update cannot be produced.

Key Takeaways

• Aldesleukin is a niche oncology cytokine with market growth constrained by toxicity and competition from checkpoint inhibitor–centered practice.
• Commercially meaningful expansion is most likely driven by combination regimens that show improved durable benefit with reduced monitoring burden.
• A quantified sales projection and a month-by-month clinical and regulatory forecast require product-level historical sales baselines and the current Purple Book/patent dossier, which are not available in this chat.

FAQs

1. Is Aldesleukin still used as monotherapy for metastatic melanoma and metastatic renal cell carcinoma?
2. Are there any active clinical trials combining Aldesleukin with PD-1 or CTLA-4 inhibitors?
3. How does IL-2 dosing strategy affect toxicity and hospitalization rates in clinical practice?
4. What is the difference between IL-2 biosimilars and authorized biologic products for Aldesleukin?
5. What endpoints in IL-2 combination trials drive FDA labeling and payer coverage decisions?

References (APA)

1. [No sources were provided in the prompt or available in this chat to cite.]