Intracranial Hemorrhage - Pipeline Insight, 2025

This “Intracranial Hemorrhage - Pipeline Insight, 2025” report provides comprehensive insights about 8+ companies and 10+ pipeline drugs in Intracranial Hemorrhage pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Intracranial Hemorrhage: Understanding

Intracranial Hemorrhage: Overview

Intracranial hemorrhage (ICH) is a life-threatening condition that requires intensive care to improve outcomes. It can be spontaneous, caused by an underlying vascular malformation, induced by trauma, or linked to therapeutic anticoagulation. Critical care aims to identify the cause, control blood pressure, correct coagulopathy, and manage high-risk vascular lesions. Assessment of neurological injury severity is performed using bedside scales and CT scans. Anticipating complications like myocardial stunning, pulmonary edema, and fever (often non-infectious) is essential. Recovery occurs over weeks to months, and expected functional independence guides patient care decisions. The management approach impacts mortality, with advanced monitoring, reducing hemorrhage expansion, and optimizing rehabilitation being future areas of focus. The four main types of intracranial hemorrhage are epidural hemorrhage, subdural hemorrhage, subarachnoid hemorrhage, and intraparenchymal hemorrhage, with differences in etiology, prognosis, and treatment.

Epidural hemorrhage can be arterial or venous in origin, typically resulting from blunt or penetrating head trauma. Arterial epidural hematomas often arise from skull fractures damaging the middle meningeal artery, while venous epidural hematomas are common in pediatric patients. Subdural hemorrhage occurs when blood enters the subdural space, often due to tearing of vessels between the brain and skull, commonly after blunt head trauma. Subarachnoid hemorrhage involves bleeding into the subarachnoid space and can be classified as aneurysmal (due to a ruptured cerebral aneurysm) or non-aneurysmal (often trauma-related). Intraparenchymal hemorrhage, which occurs within the brain tissue, can result from various causes including hypertension, arteriovenous malformations, aneurysm rupture, or trauma. Each type of hemorrhage has distinct causes, with the incidence varying by age and gender, and is associated with significant morbidity and mortality, particularly in severe cases.

Epidural hemorrhage occurs when blood accumulates between the dura mater and the inner skull, typically following skull fractures that damage arterial or venous vessels, with the middle meningeal artery being the most commonly affected. Subdural hemorrhage, often caused by head trauma, involves the rupture of blood vessels bridging the brain and skull, leading to bleeding into the subdural space. Chronic subdural hematomas may develop due to the rebleeding of these vessels and neovascularization. Subarachnoid hemorrhage results from trauma or, more commonly, from the rupture of a cerebral aneurysm, leading to bleeding into the subarachnoid space, with other causes including arteriovenous malformations (AVMs) and blood-thinning medications. Intraparenchymal hemorrhage, usually linked to hypertension, occurs when blood vessels in the brain burst, with other causes including AVM rupture, aneurysm rupture, tumors, or trauma. The putamen is the most common site of spontaneous intraparenchymal hemorrhage, particularly in individuals with uncontrolled hypertension.

Immediate neurosurgical consultation is essential for all intracranial hemorrhages, especially when there are signs of airway compromise, respiratory failure, or hemodynamic instability. For epidural hemorrhage, treatment typically involves evacuation of the hematoma and controlling the bleeding source, although smaller hematomas may be managed conservatively with close monitoring if criteria such as a hematoma volume of less than 30 mL, a clot diameter under 15 mm, and no significant midline shift are met. Subdural hemorrhage requires evacuation based on size and location, with non-surgical management including observation, imaging, and management of contributing factors like anticoagulation or hypertension. In subarachnoid hemorrhage, management focuses on reversing anticoagulation, monitoring for hydrocephalus, and addressing underlying causes such as aneurysms or Arteriovenous Malformations (AVMs). For intraparenchymal hemorrhage, blood pressure control is critical to prevent further bleeding, and treatment varies depending on the cause, including aggressive surgical evacuation for larger cerebellar hematomas or craniectomy to manage cerebral swelling. Non-operable hemorrhages may be managed conservatively with blood pressure control and neuroprotective strategies.

'Intracranial Hemorrhage- Pipeline Insight, 2025' report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Intracranial Hemorrhage pipeline landscape is provided which includes the disease overview and Intracranial Hemorrhage treatment guidelines. The assessment part of the report embraces, in depth Intracranial Hemorrhage commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Intracranial Hemorrhage collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Intracranial Hemorrhage R&D. The therapies under development are focused on novel approaches to treat/improve Intracranial Hemorrhage.

Intracranial Hemorrhage Emerging Drugs Chapters

This segment of the Intracranial Hemorrhage report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, II, I, Preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Intracranial Hemorrhage Emerging Drugs

GTx-104: Acasti Pharma Inc.

GTx-104, is a novel injectable formulation of nimodipine for the treatment of a rare disease, Aneurysmal Subarachnoid Hemorrhage (aSAH). This formulation offers several potential advantages over oral administration of nimodipine that is the current Standard of Care (SoC). GTX-104 is a clinical stage, novel, injectable formulation being developed for intravenous infusion (IV) in aSAH patients to address significant unmet medical needs. The unique nanoparticle technology of GTX-104 facilitates aqueous formulation of insoluble nimodipine for a standard peripheral IV infusion. GTX-104 provides a convenient IV delivery of nimodipine in the Intensive Care Unit potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients. Intravenous delivery of GTX-104 also has the potential to lower food effects, drug-to-drug interactions, and eliminate potential dosing errors. Further, GTX-104 has the potential to better manage hypotension in aSAH patients. GTX-104 has also been given Orphan Drug Designation by the FDA. Currently, the drug is in Phase III stage of its development for the treatment of Intracranial Hemorrhage.

Ir-CPI: Bioxodes S.A.

Ir-CPI (BIOX-101) is a novel therapeutic agent derived from a natural protein found in the salivary glands of the tick Ixodes ricinus. Ir-CPI (BIOX-101) displays an antithrombotic activity through its interaction with upstream blood coagulation factors (FXIa/FXIIa) of the intrinsic pathway. Bioxodes has also demonstrated that Ir-CPI decreases neutrophil activation and Neutrophil Extracellular Trap (NET) release. Neutrophils and NETs, networks of extracellular fibers primarily constituted of DNA, are key components of the neuroinflammatory and thrombotic processes encountered in patients with intracerebral hemorrhage (ICH). Currently, the drug is in Phase II stage of its clinical trial for the treatment of Intracranial Hemorrhage.

CN 105: AegisCN

CN-105 is a novel neuroprotective peptide developed by CereNova for the treatment of intracranial hemorrhage. This investigational drug is a five-amino-acid apolipoprotein E (apoE) mimetic that is designed to penetrate the central nervous system effectively, where it exerts its protective effects. By mimicking the action of natural apoE, CN-105 aims to modulate neuroinflammatory responses and promote recovery following brain injury. Its mechanism involves downregulating acute inflammation and enhancing cellular repair processes, making it a promising candidate for mitigating the detrimental effects of intracranial hemorrhage and improving neurological outcomes in affected patients. Currently, the drug is in Phase II stage of its clinical trial for the treatment of Intracranial Hemorrhage.

Intracranial Hemorrhage: Therapeutic Assessment

This segment of the report provides insights about the different Intracranial Hemorrhage drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Intracranial Hemorrhage

• There are approx. 8+ key companies which are developing the therapies for Intracranial Hemorrhage. The companies which have their Intracranial Hemorrhage drug candidates in the most advanced stage, i.e. Phase III include, Acasti Pharma Inc.

Phases

The report covers around 10+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Route of Administration

Intracranial Hemorrhage pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Intracranial Hemorrhage: Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Intracranial Hemorrhage therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Intracranial Hemorrhage drugs.

Intracranial Hemorrhage Report Insights

• Intracranial Hemorrhage Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Intracranial Hemorrhage Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Intracranial Hemorrhage drugs?
• How many Intracranial Hemorrhage drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Intracranial Hemorrhage?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Intracranial Hemorrhage therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Intracranial Hemorrhage and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Acasti Pharma Inc.

Bioxodes S.A.

CereNova

• NeurOp
• Novo Nordisk A/S
• BIT Pharma GmbH

Key Products

• GTX-104
• Ir-CPI
• CN 105
• NP10679
• RFVIIa
• Nicardipine

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