aldesleukin
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | PROLEUKIN | — | 1998-01-09 | fda.gov ↗ |
| Approved | US (FDA) | PROLEUKIN | — | 1992-05-05 | fda.gov ↗ |
Trials 364 · started per year
News releases announcing trial results or a regulatory action · 16
| Date | Issuer | Release |
|---|---|---|
| 2026-05-21 | Aulos Bioscience, Inc. | Results Aulos Bioscience Reports Positive Phase 2 Data for Imneskibart in Doublet Checkpoint Inhibitor-Refractory Metastatic Melanoma at 2026 ASCO Annual Meeting aulosbio.com ↗
The Phase 2 data show that imneskibart-based outpatient regimens are well tolerated and demonstrate durable clinical activity, including ongoing and deepening responses. |
| 2025-11-07 | Aulos Bioscience, Inc. | Results New Phase 2 Data for Aulos Bioscience’s Imneskibart Reveal Clinical Activity in Melanoma and Non-Small Cell Lung Cancer aulosbio.com ↗
These findings strengthen previously reported results that a combination of imneskibart and low-dose, subcutaneous aldesleukin (recombinant human IL-2) exhibits unique activity in the interleukin-2 (IL-2) class. |
| 2025-05-10 | Iltoo Pharma | Results ILTOO Pharma Announces Publication of Phase IIb Trial Results in the Lancet Demonstrating Safety and Efficacy of Low-Dose IL-2 in ALS iltoopharma.com ↗
ILTOO Pharma Announces Publication of Phase IIb Trial Results in the Lancet Demonstrating Safety and Efficacy of Low-Dose IL-2 in ALS |
| 2025-04-29 | Aulos Bioscience, Inc. | Results Aulos Bioscience Presents New Phase 2 Data for AU-007 Demonstrating Continued Strong Anti-Tumor Activity in Advanced Cancers at AACR Annual Meeting aulosbio.com ↗
Durable tumor shrinkages were also observed in patients with checkpoint inhibitor-resistant or progressed renal cell carcinoma (RCC) who received the same AU-007 and aldesleukin regimen. |
| 2025-03-25 | Mateon Therapeutics | Results Oncotelic Therapeutics Announces Successful Completion of Phase 1 Trial of OT-101 and IL-2, Highlights Findings at SWCR 2025 Conference oncotelic.com ↗
The combination showed a tolerable safety profile at the planned dosing schedule, with no unexpected safety signals identified. |
| 2024-11-07 | Aulos Bioscience, Inc. | Results Strong Evidence of AU-007’s Anti-Tumor Activity in Advanced Solid Tumor Cancers Presented at Society for Immunotherapy of Cancer (SITC) Annual Meeting aulosbio.com ↗
Preliminary Phase 2 data reveal that a combination of AU-007 and low-dose, subcutaneous aldesleukin is clinically active in melanoma, a finding consistent with Phase 1 data demonstrating clinical activity in a range of patients whose tumors had progressed through prior checkpoint inhibitors. |
| 2024-10-23 | Aulos Bioscience, Inc. | Results Aulos Bioscience Presents Phase 2 Dose Selection Data for Novel IL-2 Therapeutic Antibody, AU-007, at 36th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics aulosbio.com ↗
Additionally, increases in interferon-gamma and effector T cells (Teffs) were observed with escalating subcutaneously administered aldesleukin (recombinant human IL-2) dose levels. |
| 2024-05-23 | Aulos Bioscience, Inc. | Results Aulos Bioscience Provides Positive Interim Phase 1/2 Data From AU-007 at 2024 ASCO Annual Meeting aulosbio.com ↗
AU-007 and low-dose aldesleukin also substantially increases peripheral natural killer (NK) cells. |
| 2023-05-23 | Iltoo Pharma | Regulatory ILTOO Pharma announces that ILT-101 has achieved Orphan Drug Designation iltoopharma.com ↗
ILTOO Pharma SAS today announced that the European Medicines Agency ( EMA ) and the U.S. Food and Drug Administration ( FDA ) have granted Orphan Drug Designation (ODD) status for ILT-101 , the company’s lead drug for the treatment of amyotrophic lateral sclerosis (ALS). |
| 2022-12-06 | Iltoo Pharma | Results ILTOO Pharma announces the results of a Phase IIb trial for ALS using Low-Dose IL-2 iltoopharma.com ↗
ILTOO Pharma SAS today announced the results of MIROCALS, a Phase IIb trial in amyotrophic lateral sclerosis (ALS) using low-dose Interleukine-2 (IL-2LD), which were presented by Dr. Gilbert Bensimon at the International Symposium on ALS / Motor Neuron Diseases. |
| 2022-04-08 | Asher Biotherapeutics, Inc. | Results Asher Bio to Unveil Two New Immunotherapy Programs, a CD8+ T Cell Targeted IL-21 and a Cis-Targeted IL-2 for Cell Therapy Augmentation, at AACR Annual Meeting asherbio.com ↗ |
| 2021-11-23 | Mateon Therapeutics | Results ONCOTELIC PROVIDES 3RD QUARTER 2021 COMPARED TO 3RD QUARTER 2020 FINANCIAL RESULTS AND CORPORATE UPDATE oncotelic.com ↗
In the safety cohort treated during the Trial, the standard dosage of 140mg/m2 of OT-101was well tolerated in combination with IL-2, which has allowed for ongoing dose escalation to 190 mg/m2. |
| 2021-11-16 | Mateon Therapeutics | Results Oncotelic Announces Successful Completion of the Safety Evaluation of a TGF-β Inhibitor (OT-101) and IL-2 (Aldesleukin) in Phase 1 Combination Trial in Solid Tumor Cancers oncotelic.com ↗
In the safety cohort treated during the Trial, the standard dosage of 140mg/m2 of OT-101was well tolerated in combination with IL-2, which has allowed for ongoing dose escalation to 190 mg/m2. |
| 2021-04-19 | Mateon Therapeutics | Results ONCOTELIC THERAPEUTICS, INC. ANNOUNCED SYNERGY BETWEEN OT-101 AND IL-2 (PROLEUKIN) AT AACR-2021 oncotelic.com ↗
Oncotelic Therapeutics, Inc. (" Oncotelic " or the "Company") (OTCQB:OTLC) announced today a presentation at AACR-2021 (American Association for Cancer Research/ Annual Meeting) entitled: Combination therapy of anti-sense oligonucleotide targeting TGF-β2 (TASO) and IL-2 (Proleukin) has anti-cancer effect in solid cancer. |
| 2020-09-18 | Alkermes, Inc. | Results Alkermes Presents New Clinical Data on ALKS 4230 in Mini Oral Presentation at 2020 European Society for Medical Oncology (ESMO) Virtual Congress alkermes.com ↗
Data from the ongoing ARTISTRY-1 study showed encouraging single-agent activity of ALKS 4230 in melanoma and durable responses in multiple tumor types in combination with pembrolizumab. |
| 2018-11-06 | Alkermes, Inc. | Results Alkermes Presents New Data on ALKS 4230 at Society for Immunotherapy of Cancer's (SITC) 33rd Annual Meeting alkermes.com ↗
Consistent with the known biological activities of IL-2, administration of high-dose IL-2 resulted in an approximate 2-fold expansion of circulating cytotoxic effector CD8+ T cells and NK cells and an approximate 4-fold expansion of circulating Treg cells. |
All press releases naming this drug 24 releases
Evidence & citations 32 cited values
Every value below carries the sentence it was read from. 611 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Aldesleukin | “Temozolamide 150mg/m2 x4, cisplatin 20mg/m2 x 4, vinblastine 1.2mg/m2 x 4, bevacizumab 7.5-15 mg/kg x 1, interferon 5mg/m2 x5 and aldesleukin 36,18,9, % 9 miu/day over 4 days...” NCT01743157 ↗359“Folowed by Aldesleukin, administered at a dose of 600,000 IU/kg (based on total body weight) as an intravenous bolus over a 15-minute period approximately every 8 hours...” NCT03467516 ↗ “This study will evaluate whether the HIV vaccine ALVAC vCP1452 given in combination with interleukin-2 (IL-2), also known as aldesleukin, can increase immune system function in...” NCT00056797 ↗ “This study focuses on combining TIL therapy with Pembrolizumab (Keytruda) and Aldesleukin (IL-2) to enhance the anti-tumor immune response in patients with advanced or...” NCT06532812 ↗ “PURPOSE: High-dose aldesleukin (HD IL2) received FDA approval for the treatment of metastatic renal cell carcinoma (MRCC) in 1992, producing a 14% objective response rate (ORR)...” PMID 25424850 ↗ Nov 2014 “Subcutaneous aldesleukin (300,000IU/m2/day) and Sargramostim (250 ug/m2 twice per week) both starting 3 days before the 1st infusion and ending 7 days after the last dose of armed ATC.” NCT01081808 ↗ “IL-2 (Interleukin-2; Aldesleukin; Proleukin) administered daily as a single subcutaneous injection 0.30 MIU per meter squared body surface area for a duration of 4 weeks.” NCT02739412 ↗ “called IL-2 (Aldesleukin), which will be given as an every-other-day injection under the skin (subcutaneous) at very low doses for 6 weeks after the ASCT” NCT02676622 ↗ “Famotine 20mg IV push daily just prior to the aldesleukin (IL-2) IL-2 18 million IU/m2 in 50 mL 5% D5 or NS IVPB over 15 - 30 minutes daily for 5 days” NCT01289678 ↗ “A Multi-Center Study of High Dose Aldesleukin (Interleukin-2) + Vemurafenib Therapy in Patients With BRAFV600 Mutation Positive Metastatic Melanoma” NCT01683188 ↗ “Patients were randomised (1:1:1) to aldesleukin 2 MIU, 1 MIU, or placebo once daily for 5 days every 4 weeks for 3 cycles.” PMID 32651161 ↗ Jul 2020 |
| Known as | Aldesleukin, Proleukin, IL-2 | “Aldesleukin, Proleukin, IL-2” NCT06152809 ↗ |
| Known as | HD IL2 | “PURPOSE: High-dose aldesleukin (HD IL2) received FDA approval for the treatment of metastatic renal cell carcinoma (MRCC) in 1992, producing a 14% objective response rate (ORR)...” PMID 25424850 ↗ Nov 20141“High dose interleukin-2 (HD IL2) administered week 1 and 4 of each course (approximately 12 weeks)” NCT04562129 ↗ |
| Known as | High Dose Interleukin-2 | “High Dose Interleukin-2” NCT02989714 ↗ |
| Known as | HrIL-2 | “Patients receive low dose recombinant human Interleukin-2（HrIL-2）” NCT02932137 ↗1“Patients receive low dose recombinant human Interleukin-2（HrIL-2）” NCT02084238 ↗ |
| Known as | IL-2 | “This study is designed as a randomized, open trial of intermittent continuous infusions of Interleukin-2 in HIV seropositive patients with a CD4 cell count between 200 and 500...” NCT00001474 ↗90“This investigation is a sub-study of the 6-year multinational ESPRIT (Evaluation of Subcutaneous Proleukin in a Randomized International Trial) protocol. It will compare the...” NCT00050726 ↗ “This study is for patients with advanced stage III or stage IV melanoma not adequately treated by surgery who have progressed after treatment with nivolumab or pembrolizumab....” NCT02796352 ↗ “The investigators hypothesize that ex vivo expanded human autologous CD4+CD127lo/-CD25+ polyclonal regulatory T cells (Polyclonal Tregs) plus Interleukin-2 (IL-2) administered...” NCT02772679 ↗ “This study will assess the highest tolerable intratumoral dose of ipilimumab (Yervoy) in combination with IL-2 (Proleukin) in patients with unresectable stages III-IV melanoma...” NCT01672450 ↗ “This study will evaluate the long-term toxicity and obtain preliminary information about long-term efficacy of the combination of antiretroviral therapies and interleukin-2...” NCT00001282 ↗ “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...” NCT00000728 ↗ “Beginning 6 hours after TIL infusion, patients receive high-dose aldesleukin (IL-2) IV three times daily on days 0-5 (for up to 14 doses) OR low-dose IL-2 subcutaneously twice...” NCT01005537 ↗ “AIMS/HYPOTHESIS: Low-dose IL-2 (ld-IL2) selectively activates and expands regulatory T cells (Tregs) and thus has the potential to skew the regulatory/effector T (Treg/Teff)...” PMID 32607749 ↗ Jul 2020 “Determine the safety of peripheral blood lymphocytes (PBLs) retrovirally transduced with an anti-MART-1 T-cell receptor (TCR) gene followed by high-dose aldesleukin (IL-2) and...” NCT00091104 ↗ “This study will evaluate whether the HIV vaccine ALVAC vCP1452 given in combination with interleukin-2 (IL-2), also known as aldesleukin, can increase immune system function in...” NCT00056797 ↗ |
| Known as | IL2-fd | “In humans, the use of low doses of interleukin-2 (IL2-fd) (ILT-101) leads to activation and selective expansion of Tregs” NCT07589842 ↗ |
| Known as | IL2LD | “low-dose interleukin-2 (IL2LD) activates Tregs” PMID 37245191 ↗ May 2023 |
| Known as | ILT-101 | “ILT-101: 1MIU/day in a volume of 1 ml; subcutaneous injection every day during 5 consecutive days and then every week between Day 63 and Day 354.” NCT05153070 ↗ |
| Known as | Inteleukin-2 | “Biological: Inteleukin-2” NCT00277758 ↗ |
| Known as | Interleukin 2 (IL2) | “Interleukin-2 (IL-2)” NCT02169609 ↗1“Interleukin 2 (IL2)” NCT04729543 ↗ |
| Known as | Interleukin-2 | “The investigators hypothesize that ex vivo expanded human autologous CD4+CD127lo/-CD25+ polyclonal regulatory T cells (Polyclonal Tregs) plus Interleukin-2 (IL-2) administered...” NCT02772679 ↗251“This phase II trial studies efficacy of extracorporeal photopheresis and low dose aldesleukin (interleukin-2) in treating patients with chronic graft-versus-host disease...” NCT03007238 ↗ “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...” NCT00000728 ↗ “subcutaneous injection of Interleukin-2 during 5 days, once daily repeated administration(Induction period). At day 15 single administration of Interleukin-2 every two weeks...” NCT01862120 ↗ “Each patients will receive four cycles of subcutaneous Proleukin (Interleukin-2, IL-2) (Week-1; 1.5 million IU (MIU)/d from Day-1 to Day-5, Week-3, -6, -9; 3MIU/d from Day-1 to...” NCT02714959 ↗ “Clinical and immunologic effects of intranodal autologous tumor lysate-dendritic cell vaccine with Aldesleukin (Interleukin 2) and IFN-{alpha}2a therapy in metastatic renal...” PMID 19622576 ↗ Jul 2009 “Intraperitoneal chemotherapy (fluorouracil + nab-paclitaxel + cisplatin + interleukin-2) PLUS systemic chemotherapy (SOX regimen: oxaliplatin + tegafur-gimeracil-oteracil potassium)” NCT07034742 ↗ “Subcutaneous injection of 1.5 million international units (MIU) of Aldesleukin (Proleukin®, Interleukin-2) once daily in 5-day courses every three weeks for a total of 4 cycles.” NCT03312335 ↗ “Administration of interleukin-2 (also known as aldesleukin or IL-2), a naturally occurring cytokine, has been proposed as a way to maintain the number of CD8 cells.” NCT00110578 ↗ “Interleukin-2 (Proleukin): 125.000 IU/kg/day s.c. for maximum 12 days as inpatients with a 2 days break after the first 4-5 doses (maximum 10 days dosing).” NCT04165967 ↗ “The aim of this study was to assess efficacy and safety of adjuvant treatment with low doses of interleukin-2 (IL-2)+interferon-α (IFN-α) in operable RCC.” PMID 25304727 ↗ Nov 2014 |
| Known as | Interleukin-2 (aldesleukin) | “Interleukin-2 (aldesleukin)” NCT00910650 ↗ |
| Known as | Interleukin-2, Proleukin, Chiron B.V. | “Interleukin-2, Proleukin®, Chiron B.V.” NCT00935558 ↗3“Interleukin-2, Proleukin®, Chiron B.V.” NCT00197912 ↗ “Interleukin-2, Proleukin®, Chiron B.V.” NCT00937300 ↗ “Interleukin-2, Proleukin®, Chiron B.V.” NCT00937625 ↗ |
| Known as | interleukin-2: IL-2, aldesleukin, Proleukin(R) | “interleukin-2: IL-2, aldesleukin, Proleukin(R)” NCT00640796 ↗ |
| Known as | L2-7001 | “Safety and Effectiveness of L2-7001 (Interleukin-2) in HIV-Positive Patients Receiving Anti-HIV Therapy” NCT00002449 ↗ |
| Known as | ld-IL2 | “AIMS/HYPOTHESIS: Low-dose IL-2 (ld-IL2) selectively activates and expands regulatory T cells (Tregs) and thus has the potential to skew the regulatory/effector T (Treg/Teff)...” PMID 32607749 ↗ Jul 20202“Low-dose interleukin 2 (Ld-IL2) has shown therapeutic effects in autoimmune diseases, particularly systemic lupus erythematosus (SLE), yet optimal dosage has not been...” PMID 42014401 ↗ Apr 2026 “Patients with T1D were treated with a single infusion of autologous polyclonal Tregs followed by one or two 5-day courses of recombinant human low-dose IL-2 (ld-IL-2).” PMID 34324441 ↗ Sep 2021 |
| Known as | Low-dose interleukin 2 | “Low-dose interleukin 2 (Ld-IL2) has shown therapeutic effects in autoimmune diseases, particularly systemic lupus erythematosus (SLE), yet optimal dosage has not been...” PMID 42014401 ↗ Apr 2026 |
| Known as | PEG IL-2 | “polyethylene glycolated interleukin-2 (PEG IL-2)” NCT00001997 ↗ |
| Known as | Proleukin | “treatment group patients will be treated intralesionally with IL-2 (Proleukin (Aldesleukin), Novartis Pharmaceuticals Canada Inc.) at a dose of 500,000 International Units (IU)...” NCT03233828 ↗32“Aldesleukin (Proleukin; recombinant human IL-2), which is administered at high doses to activate the immune system in cancer immunotherapy, is now being repositioned to treat...” PMID 27727279 ↗ Oct 2016 “This study will assess the highest tolerable intratumoral dose of ipilimumab (Yervoy) in combination with IL-2 (Proleukin) in patients with unresectable stages III-IV melanoma...” NCT01672450 ↗ “Subcutaneous injection of 1.5 million international units (MIU) of Aldesleukin (Proleukin®, Interleukin-2) once daily in 5-day courses every three weeks for a total of 4 cycles.” NCT03312335 ↗ “IL-2 (Interleukin-2; Aldesleukin; Proleukin) administered daily as a single subcutaneous injection 0.30 MIU per meter squared body surface area for a duration of 4 weeks.” NCT02739412 ↗ “IL-2 (Proleukin) will be administered on Day 2 (within 24h after NK infusion), 4 and 6 as a subcutaneous dose of 5x105 UI/m2, following the label instructions.” NCT05385705 ↗ “Interleukin-2 (Proleukin): 125.000 IU/kg/day s.c. for maximum 12 days as inpatients with a 2 days break after the first 4-5 doses (maximum 10 days dosing).” NCT04165967 ↗ “A Study to Evaluate the Effects of Giving Proleukin (rIL-2) to HIV-Positive Patients With CD4 Counts Greater Than 300 Cells/mm3” NCT00000949 ↗ “immunotherapy with subcutaneous Maxamine (Histamine Dihydrochloride) Plus Proleukin (Interleukin-2) Versus No Treatment” NCT00003991 ↗ “recombinant interleukin 2 (aldesleukin, Proleukin ®) subcutaneously according to the following dosing schedule:” NCT01840046 ↗ “low doses 2·4×106 IU/m2 rhIL-2 (Proleukin®) (Chiron Emeryville, CA, USA), injected s.c.” NCT06152367 ↗ |
| Known as | Proleukin = Interleukin II | “Proleukin = Interleukin II” NCT00149162 ↗ |
| Known as | recombinant human IL-2 | “Aldesleukin (Proleukin; recombinant human IL-2), which is administered at high doses to activate the immune system in cancer immunotherapy, is now being repositioned to treat...” PMID 27727279 ↗ Oct 20161“Female NZB/W F1 mice received recombinant human IL-2 (3 × 104 IU/dose)” PMID 34094549 ↗ Jun 2021 |
| Known as | Recombinant Human Interleukin-2 | “recombinant human interleukin-2 in treating subjects with refractory cGVHD” NCT06920199 ↗6“recombinant human interleukin 2 (aldesleukin; IL-2)” NCT00000986 ↗ “recombinant human interleukin 2 (rhIL2) PROLEUKIN ®” NCT06152367 ↗ “Recombinant Human Interleukin-2” NCT04237987 ↗ “recombinant human interleukin-2” NCT00005576 ↗ “Recombinant Human Interleukin-2” NCT04062019 ↗ “Recombinant Human Interleukin-2” NCT05495321 ↗ |
| Known as | Recombinant Human Interleukin-2(1) for Injection | “Recombinant Human Interleukin-2(1) for Injection” NCT05631717 ↗ |
| Known as | recombinant human low-dose IL-2 | “Patients with T1D were treated with a single infusion of autologous polyclonal Tregs followed by one or two 5-day courses of recombinant human low-dose IL-2 (ld-IL-2).” PMID 34324441 ↗ Sep 2021 |
| Known as | recombinant interleukin-2 | “recombinant interleukin-2 (Proleukin, Aldesleukin)” NCT00040586 ↗1“recombinant interleukin-2 ( aldesleukin; IL-2 )” NCT00000680 ↗ |
| Known as | Rh-Interleukin-2 | “8 Weeks SC Administration of Aldesleukin (Rh-Interleukin-2 [IL-2]) to 4 Weeks of IV Administration of Rituximab” NCT00100737 ↗ |
| Known as | rhIL-2 | “One million units of Recombinant Human Interleukin-2 (rhIL-2) was administered subcutaneously five days every week for 4 weeks and then once a week for 8 weeks.” NCT04062006 ↗6“Human recombinant interleukin-2 (rhIL-2) is a biological signalling protein playing a key role in the regulation of the immune system.” NCT01862120 ↗ “Recombinant Human Interleukin-2 (RhIL-2) was administered subcutaneously at a dose of 1 million IU every other day for 4 weeks” NCT02569463 ↗ “One million units of Recombinant Human Interleukin-2 (rhIL-2) was administered subcutaneously every other day for 3 months.” NCT04237987 ↗ “One million units of Recombinant Human Interleukin-2 (rhIL-2) was administered subcutaneously every other day for 3 months.” NCT04062019 ↗ “recombinant human interleukin 2 (rhIL2) PROLEUKIN ®” NCT06152367 ↗ “Interleukin 2, 1MUI.= Proleukin®, RhIL-2” NCT01988506 ↗ |
| Known as | rIL-2 | “A Study to Evaluate the Effects of Giving Proleukin (rIL-2) to HIV-Positive Patients With CD4 Counts Greater Than 300 Cells/mm3” NCT00000949 ↗1“rIL-2 is administered sc daily over 5 days” NCT01662804 ↗ |
| Action | Restore | “Replacement of IL-2 at nontoxic doses” NCT00000820 ↗ |
| Modality | Protein / enzyme biologic | “recombinant interleukin-2 ( aldesleukin; IL-2 )” NCT00000680 ↗ |
| Route | Subcutaneous | “by Subcutaneous Injection” NCT00000820 ↗ |