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Last Updated: January 20, 2025

Investigational Drug Information for Idasanutlin


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What is the development status for investigational drug Idasanutlin?

Idasanutlin is an investigational drug.

There have been 15 clinical trials for Idasanutlin. The most recent clinical trial was a Phase 1 trial, which was initiated on December 30th 2015.

The most common disease conditions in clinical trials are Leukemia, Myeloid, Acute, Leukemia, and Leukemia, Myeloid. The leading clinical trial sponsors are Hoffmann-La Roche, National Center for Tumor Diseases, Heidelberg, and University Hospital Heidelberg.

There are thirty-three US patents protecting this investigational drug and three hundred international patents.

Recent Clinical Trials for Idasanutlin
TitleSponsorPhase
Trial of Idasanutlin and Selinexor Therapy for Children With Progressive/Relapsed AT/RT or Extra-CNS Malignant Rhabdoid TumorsSt. Jude Children's Research HospitalPhase 1
Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform StudyHoffmann-La RochePhase 2
A Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Activity of Idasanutlin in Combination With Either Chemotherapy or Venetoclax in the Treatment of Pediatric and Young Adult Participants With Relapsed/Refractory Acute LeHoffmann-La RochePhase 1/Phase 2

See all Idasanutlin clinical trials

Clinical Trial Summary for Idasanutlin

Top disease conditions for Idasanutlin
trials011223344Leukemia, Myeloid, AcuteLeukemiaLeukemia, MyeloidNeoplasms[disabled in preview]
Top clinical trial sponsors for Idasanutlin
trials0123456789101112Hoffmann-La RocheNational Center for Tumor Diseases, HeidelbergUniversity Hospital Heidelberg[disabled in preview]

See all Idasanutlin clinical trials

US Patents for Idasanutlin

DrugnamePatent NumberPatent TitlePatent AssigneeEstimated Expiration
Idasanutlin ⤷  Subscribe Treatment of ophthalmic conditions by selectively removing senescent cells from the eye Unity Biotechnology, Inc. (Brisbane, CA) Buck Institute for Research on Aging (Novato, CA) Mayo Foundation for Medical Education and Research (Rochester, MN) ⤷  Subscribe
Idasanutlin ⤷  Subscribe Compounds targeting proteins, compositions, methods, and uses thereof Biotheryx, Inc. (Chappaqua, NY) ⤷  Subscribe
Idasanutlin ⤷  Subscribe Treatment of myelodysplastic syndromes with 2-O and,or 3-O desulfated heparinoids Cantex Pharmaceuticals, Inc. (Weston, FL) ⤷  Subscribe
Idasanutlin ⤷  Subscribe Spiro[3H-indole-3,2'-pyrrolidin]-2(1H)-one compounds and derivatives as MDM2-P53 inhibitors Boehringer Ingelheim International GmbH (Ingelheim am Rhein, DE) ⤷  Subscribe
Idasanutlin ⤷  Subscribe Controlled release dosage form TRIASTEK, INC. (Nanjing, CN) ⤷  Subscribe
Idasanutlin ⤷  Subscribe Spiro[3H-indole-3,2'-pyrrolidin]-2(1H)-one compounds and derivatives as MDM2-P53 inhibitors Boehringer Ingelheim International GmbH (Ingelheim am Rhein, DE) ⤷  Subscribe
Idasanutlin ⤷  Subscribe Formylated N-heterocyclic derivatives as FGFR4 inhibitors NOVARTIS AG (Basel, CH) ⤷  Subscribe
>Drugname>Patent Number>Patent Title>Patent Assignee>Estimated Expiration
Showing 1 to 7 of 7 entries

International Patents for Idasanutlin

DrugnameCountryDocument NumberEstimated ExpirationRelated US Patent
Idasanutlin Australia AU2015211021 2034-01-28 ⤷  Subscribe
Idasanutlin Australia AU2020244600 2034-01-28 ⤷  Subscribe
Idasanutlin Australia AU2022256167 2034-01-28 ⤷  Subscribe
Idasanutlin Brazil BR112016017564 2034-01-28 ⤷  Subscribe
Idasanutlin Canada CA2939121 2034-01-28 ⤷  Subscribe
Idasanutlin Canada CA3100140 2034-01-28 ⤷  Subscribe
Idasanutlin China CN106163557 2034-01-28 ⤷  Subscribe
>Drugname>Country>Document Number>Estimated Expiration>Related US Patent
Showing 1 to 7 of 7 entries

Idasanutlin: A Promising MDM2 Inhibitor in Clinical Development

Overview of Idasanutlin

Idasanutlin, also known by its synonyms RG-7388 and RO-5503781, is a small molecule drug developed by F. Hoffmann-La Roche Ltd. It functions as an MDM2 inhibitor, targeting the MDM2 protein which regulates the tumor suppressor protein p53. This mechanism makes idasanutlin a potential treatment for various cancers and other diseases[4][5].

Current Development Stage

As of the latest updates, idasanutlin is in Phase II clinical trials for several indications, including neuroblastoma, acute myeloid leukemia, acute lymphoblastic leukemia, solid tumors, and other hematological and solid malignancies. In some regions, such as China, it has also reached Phase II, indicating progress in its development in specific markets[1][4].

Clinical Trials and Outcomes

Idasanutlin has been evaluated in Phase I and II clinical trials for its efficacy and safety. These trials have shown promising results, particularly in reducing the need for phlebotomy, decreasing spleen size, and slowing disease progression in patients with polycythemia vera. The drug has also demonstrated durable clinical benefits in these patients, although there have been transient increments in TP53 mutations, which are being closely monitored[3].

Indications and Therapeutic Areas

Idasanutlin is being investigated for a wide range of therapeutic areas, including:

  • Neuroblastoma: Currently in Phase II trials.
  • Acute Myeloid Leukemia (AML): Showing promise in clinical trials.
  • Acute Lymphoblastic Leukemia (ALL): Under active investigation.
  • Solid Tumors: Including breast cancer, prostate cancer, and glioblastoma.
  • Hematological Malignancies: Such as diffuse large B-cell lymphoma, follicular lymphoma, and multiple myeloma.
  • Other Conditions: Including polycythemia vera and essential thrombocythemia[1][4][5].

Likelihood of Approval and Phase Transition Success Rate

The likelihood of approval and phase transition success rate for idasanutlin are critical factors in its development. According to GlobalData, Phase II drugs for neuroblastoma have a 21% phase transition success rate (PTSR) benchmark for progressing into Phase III. Idasanutlin's drug-specific PTSR and likelihood of approval scores are being closely tracked and compared to these benchmarks[1].

Market Projections and Industry Context

The development of idasanutlin is part of a broader trend in the pharmaceutical industry, particularly in the field of oncology. The global market for contract research organization (CRO) services, which play a crucial role in drug development, is projected to grow from USD 86.33 billion in 2024 to USD 175.46 billion by 2032, with a CAGR of 9.3%. This growth is driven by increasing R&D investments by pharmaceutical and biotechnological companies, as well as the rising prevalence of chronic and neurological diseases[2].

Orphan Drug Designation

Idasanutlin has been designated as an orphan drug, which provides it with market exclusivity and financial incentives to encourage the development of treatments for rare diseases. This designation is significant as it highlights the drug's potential to address unmet medical needs in rare and serious conditions[4].

Competitive Landscape

The development of MDM2 inhibitors like idasanutlin is part of a global effort, with multiple organizations and countries involved. As of 2023, there are 57 MDM2 drugs in development worldwide, covering 57 indications and involving 144 clinical trials. This competitive landscape underscores the potential and interest in MDM2 inhibitors as a new approach to cancer treatment[4].

Key Takeaways

  • Development Stage: Idasanutlin is currently in Phase II clinical trials for various indications.
  • Clinical Outcomes: The drug has shown durable clinical benefits in reducing disease progression and improving patient outcomes.
  • Therapeutic Areas: Idasanutlin is being investigated for a broad range of cancers and hematological malignancies.
  • Market Projections: The growth of the CRO services market indicates a favorable environment for drug development.
  • Orphan Drug Designation: Provides market exclusivity and financial incentives.
  • Competitive Landscape: Part of a global effort with multiple MDM2 inhibitors in development.

FAQs

What is idasanutlin and how does it work?

Idasanutlin is a small molecule drug that inhibits the MDM2 protein, which regulates the tumor suppressor protein p53. This mechanism makes it a potential treatment for various cancers by reactivating p53's tumor-suppressing functions.

What are the current clinical trial stages for idasanutlin?

Idasanutlin is currently in Phase II clinical trials for several indications, including neuroblastoma, acute myeloid leukemia, and solid tumors.

What are the key therapeutic areas for idasanutlin?

Idasanutlin is being investigated for neuroblastoma, acute myeloid leukemia, acute lymphoblastic leukemia, solid tumors, and various hematological malignancies.

What is the significance of idasanutlin's orphan drug designation?

The orphan drug designation provides idasanutlin with market exclusivity and financial incentives to encourage the development of treatments for rare and serious diseases.

How does the market projection for CRO services impact idasanutlin's development?

The growing market for CRO services indicates increased investment in R&D by pharmaceutical companies, which is favorable for the development of drugs like idasanutlin.

What is the competitive landscape for MDM2 inhibitors like idasanutlin?

There are 57 MDM2 drugs in development worldwide, involving 144 clinical trials and covering 57 indications, highlighting a significant global effort in this field.

Sources

  1. Pharmaceutical Technology: "Idasanutlin by F. Hoffmann-La Roche for Neuroblastoma: Likelihood of Approval and Phase Transition Success Rate Model"
  2. Fortune Business Insights: "Contract Research Organization [CRO] Services Market, 2032"
  3. ASH Conference: "Durable Clinical Benefits of Idasanutlin Therapy in Hydroxyurea-Resistant Polycythemia Vera"
  4. Patsnap Synapse: "New approach to cancer treatment-MDM2 inhibitors"
  5. Patsnap Synapse: "Idasanutlin - Drug Targets, Indications, Patents"

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