This section highlights FDA-related milestones and regulatory updates for drugs developed by Tiziana Life Sciences (TLSA).
Over the past two years, Tiziana Life Sciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
18F-PBR06-PET and Foralumab. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
18F-PBR06-PET - FDA Regulatory Timeline and Events
18F-PBR06-PET is a drug developed by Tiziana Life Sciences for the following indication: Treating Moderate Alzheimer's Disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- 18F-PBR06-PET
- Announced Date:
- May 15, 2025
- Indication:
- Treating Moderate Alzheimer's Disease
Announcement
Tiziana Life Sciences, Ltd. announced the publication of a new study in the Journal of ‘Clinical Nuclear Medicine' demonstrating that intranasal administration of foralumab significantly dampened microglial activation in a 78-year old patient with moderate Alzheimer's disease (AD) treated as part of a Food and Drug Administration (FDA) expanded access program.
AI Summary
Tiziana Life Sciences recently announced a new study published in the Journal of Clinical Nuclear Medicine. The study showed that intranasal administration of foralumab, a fully human anti-CD3 monoclonal antibody, significantly reduced microglial activation in a 78-year-old patient with moderate Alzheimer’s disease. This patient was treated under a Food and Drug Administration expanded access program, marking the first reported use of 18F-PBR06-PET imaging in a patient with moderate AD dementia.
The research, led by experts at Brigham and Women’s Hospital, used advanced PET scans to measure changes in neuroinflammation. The findings suggest that intranasal foralumab may help control microglial activity, offering a promising new approach to target the inflammation seen in Alzheimer’s disease. These results are encouraging and support further research with larger and controlled studies.
Read Announcement
Foralumab - FDA Regulatory Timeline and Events
Foralumab is a drug developed by Tiziana Life Sciences for the following indication: Crohn's disease with decreases in the classic side effects of cytokine release syndrome.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Foralumab
- Announced Date:
- May 9, 2025
- Indication:
- Crohn's disease with decreases in the classic side effects of cytokine release syndrome
Announcement
Tiziana Life Sciences, Ltd. announced results of a PET scan showing a marked reduction in microglia activation associated with neuroinflammation in a patient suffering from moderate Alzheimer's disease (AD) who was treated for three months with intranasal foralumab under an expanded access program.
AI Summary
Tiziana Life Sciences announced promising new data from a PET scan in a patient with moderate Alzheimer’s disease who received intranasal foralumab for three months under an expanded access program. The scan showed a marked reduction in microglia activation, which is a key indicator of neuroinflammation linked to the progression of Alzheimer’s. Intranasal foralumab, a fully human anti-CD3 monoclonal antibody, appears to reduce neuroinflammation by dampening microglial activity. This reduction in the PET signal suggests that the treatment may be effective in modifying one of the disease’s underlying pathological processes. The findings were presented at a recent conference and highlight foralumab’s potential role in mitigating neuroinflammation, offering hope for new therapeutic strategies in treating Alzheimer’s disease. Further studies with more patients are needed to confirm these encouraging results.
Read Announcement- Drug:
- Foralumab
- Announced Date:
- May 6, 2025
- Indication:
- Crohn's disease with decreases in the classic side effects of cytokine release syndrome
Announcement
Tiziana Life Sciences, Ltd. announced promising results from an open-label clinical study evaluating nasal foralumab, the world's only fully human anti-CD3 monoclonal antibody administered intranasally, for the treatment of non-active secondary progressive multiple sclerosis (na-SPMS).
AI Summary
Tiziana Life Sciences, Ltd. announced encouraging outcomes from an open‐label clinical study evaluating intranasal foralumab, the world’s only fully human anti‐CD3 monoclonal antibody delivered through the nose. The study in patients with non‐active secondary progressive multiple sclerosis (na‑SPMS) demonstrated a strong safety profile, with patients showing stable Expanded Disability Status Scale (EDSS) scores—a promising sign for those with limited treatment options.
The study further highlighted key benefits including improvements in fatigue, as measured by the Modified Fatigue Impact Scale (MFIS), and significant reductions in microglial activation observed via TSPO-PET imaging. These results suggest that nasal foralumab induces regulatory immune responses and reduces harmful central nervous system inflammation, paving the way for further research into managing progression independent of relapse activity in MS.
Read Announcement- Drug:
- Foralumab
- Announced Date:
- April 23, 2025
- Indication:
- Crohn's disease with decreases in the classic side effects of cytokine release syndrome
Announcement
Tiziana Life Sciences, Ltd announced that dosing has commenced at the fourth clinical site in its ongoing Phase 2 trial evaluating intranasal foralumab in patients with non-active secondary progressive multiple sclerosis (na-SPMS).
AI Summary
Tiziana Life Sciences, Ltd. announced that dosing has begun at the fourth clinical site in its ongoing Phase 2 trial for intranasal foralumab, a fully human, anti-CD3 monoclonal antibody. The study focuses on patients with non-active secondary progressive multiple sclerosis (na-SPMS) and is designed as a blinded, placebo-controlled trial. University of Massachusetts has joined other prominent institutions such as Brigham and Women’s Hospital, Yale Multiple Sclerosis Center, and Johns Hopkins University to help evaluate the treatment.
This trial is expected to finish its blinded phase by the end of 2025, after which all participants will have the chance to receive the actual treatment during a six-month open-label extension phase to assess long-term safety and benefits. The intranasal administration method allows patients to dose at home, potentially improving compliance compared to traditional intravenous treatments.
Read Announcement- Drug:
- Foralumab
- Announced Date:
- April 2, 2025
- Indication:
- Crohn's disease with decreases in the classic side effects of cytokine release syndrome
Announcement
Tiziana Life Sciences, Ltd. announced dosing has commenced at Johns Hopkins University (JHU) Autoimmunity Center of Excellence, the third clinical site in its Phase 2 trial evaluating intranasal foralumab for the treatment of non-active Secondary Progressive Multiple Sclerosis (na-SPMS).
AI Summary
Tiziana Life Sciences, Ltd. announced that dosing has begun at Johns Hopkins University’s Autoimmunity Center of Excellence. This marks the third clinical site in its Phase 2 trial for intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, which is being studied for the treatment of non-active Secondary Progressive Multiple Sclerosis (na-SPMS). The trial is randomized, double-blind, and placebo-controlled, and aims to evaluate the safety, tolerability, and effectiveness of the treatment. Johns Hopkins joins other respected centers like Brigham and Women’s Hospital and Yale Medical Center in this effort. Dr. Pavan Bhargava, the principal investigator at Johns Hopkins, highlighted the need for new treatment options for na-SPMS patients who have limited choices. The study will help determine if intranasal foralumab can reduce neuroinflammation and potentially slow the progression of this challenging condition.
Read Announcement- Drug:
- Foralumab
- Announced Date:
- March 25, 2025
- Indication:
- Crohn's disease with decreases in the classic side effects of cytokine release syndrome
Announcement
Tiziana Life Sciences, Ltd. announced dosing of new patients at Yale MS Center which is participating in our multicenter Phase 2 clinical trial evaluating intranasal foralumab for non-active Secondary Progressive Multiple Sclerosis (na-SPMS).
AI Summary
Tiziana Life Sciences, Ltd. announced that new patients are now being dosed with intranasal foralumab at the Yale MS Center. This dosing is part of a multicenter Phase 2 clinical trial, which is evaluating the drug’s safety, tolerability, and its effect on microglial activation in patients with non-active Secondary Progressive Multiple Sclerosis (na-SPMS).
The trial uses advanced brain imaging technology along with immunological assessments to collect clinical evidence. In addition to Yale, other respected centers including Johns Hopkins, U Mass Medical Center, and Brigham and Women’s Hospital are also participating. This study marks an important step in exploring intranasal foralumab as a novel immune-based treatment, potentially addressing significant unmet needs for patients living with na-SPMS.
Read Announcement- Drug:
- Foralumab
- Announced Date:
- March 4, 2025
- Indication:
- Crohn's disease with decreases in the classic side effects of cytokine release syndrome
Announcement
Tiziana Life Sciences, Ltd. announced the submission of its Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a phase 2 clinical trial in ALS.
AI Summary
Tiziana Life Sciences, Ltd. recently submitted its Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a phase 2 clinical trial focused on Amyotrophic Lateral Sclerosis (ALS). This development is an important step toward testing their leading candidate, intranasal foralumab, a fully human anti-CD3 monoclonal antibody. The trial, which will enroll approximately 20 patients, aims to evaluate the safety and early indications of effectiveness of the treatment in slowing ALS progression. Tiziana’s work on the trial is supported by the ALS Association and builds on promising preclinical research. The company believes this trial could bring significant improvements in how ALS is treated, offering hope to patients with this rapidly progressing and fatal disease. The IND submission marks a milestone in Tiziana Life Sciences' commitment to advancing new therapies for neurodegenerative conditions.
Read Announcement- Drug:
- Foralumab
- Announced Date:
- February 27, 2025
- Indication:
- Crohn's disease with decreases in the classic side effects of cytokine release syndrome
Announcement
Tiziana Life Sciences, Ltd. announced the publication of a landmark study in Nature Neuroscience demonstrating that nasal administration of Tiziana's anti-CD3 monoclonal antibody significantly reduced neuroinflammation and improved recovery. Modulating the neuroinflammatory response correlated with improved neurological outcomes.
AI Summary
Tiziana Life Sciences recently published a landmark study in Nature Neuroscience showing that nasal delivery of its anti-CD3 monoclonal antibody, foralumab, can significantly reduce neuroinflammation and aid recovery. The study demonstrated that this treatment activates IL-10 producing regulatory T cells, which in turn modulate brain microglia activity. As a result, key improvements were observed, including reduced anxiety, less cognitive decline, and enhanced motor skills, all of which contributed to better overall neurological outcomes in a traumatic brain injury model.
This breakthrough supports the use of nasal anti-CD3 therapy as an innovative approach to control neuroinflammation, offering hope for improved recovery in patients suffering from traumatic brain injury and other related neurological conditions. The study’s findings highlight the potential of non-invasive immunomodulation as a new strategy in treating serious brain injuries.
Read Announcement- Drug:
- Foralumab
- Announced Date:
- January 10, 2025
- Indication:
- Crohn's disease with decreases in the classic side effects of cytokine release syndrome
Announcement
Tiziana Life Sciences, Ltd. announced findings on the prolonged benefits of its nasal anti-CD3 monoclonal antibody in sustaining tissue homeostasis and mitigating the side effects associated with GLP-1 agonists discontinuation.
AI Summary
Tiziana Life Sciences has announced promising research findings on its nasal anti-CD3 monoclonal antibody. The company’s innovative treatment has shown prolonged benefits in maintaining tissue homeostasis and reducing the adverse side effects often seen when patients stop using GLP-1 agonists. GLP-1 drugs, widely used for metabolic disorders, can lead to challenges such as muscle and bone loss, resulting in treatment discontinuation. Tiziana’s study demonstrated that when used alongside a GLP-1 agonist, the nasal anti-CD3 therapy not only enhances its therapeutic effects but may also sustain these benefits after the GLP-1 is stopped. By promoting the activity of regulatory T cells and reducing inflammation in tissues, this approach offers a novel, non-toxic solution for improving long-term patient outcomes and managing side effects linked to prolonged GLP-1 drug use.
Read Announcement- Drug:
- Foralumab
- Announced Date:
- January 8, 2025
- Indication:
- Crohn's disease with decreases in the classic side effects of cytokine release syndrome
Announcement
Tiziana Life Sciences, Ltd. announced that a review article titled "Immune mechanisms and shared immune targets in neurodegenerative diseases" was published in Nature Reviews Neurology, highlighting the therapeutic potential of intranasal foralumab in various neurodegenerative diseases including Multiple Sclerosis (MS), Alzheimer's disease, ALS, and Parkinsons disease.
AI Summary
Tiziana Life Sciences recently announced that a review article titled "Immune mechanisms and shared immune targets in neurodegenerative diseases" has been published in Nature Reviews Neurology. The article highlights the promising therapeutic potential of intranasal foralumab, a fully human anti-CD3 monoclonal antibody. Researchers point to foralumab's ability to dampen microglial activation—a process implicated in diseases such as Multiple Sclerosis, Alzheimer’s disease, ALS, and Parkinson’s disease. The review discusses how both the adaptive and innate immune systems play roles in these neurodegenerative disorders and emphasizes that targeting common immune cells like microglia, monocytes, and T cells may offer shared treatment avenues across different conditions. Intranasal delivery of foralumab may provide an effective and well-tolerated option for patients with limited treatment choices, underlining the innovative approach taken by Tiziana Life Sciences in addressing major unmet medical needs.
Read Announcement- Drug:
- Foralumab
- Announced Date:
- December 17, 2024
- Indication:
- Crohn's disease with decreases in the classic side effects of cytokine release syndrome
Announcement
Tiziana Life Sciences, Ltd. announced a significant milestone in its clinical development program for Alzheimer's disease.
Read Announcement- Drug:
- Foralumab
- Announced Date:
- December 4, 2024
- Indication:
- Crohn's disease with decreases in the classic side effects of cytokine release syndrome
Announcement
Tiziana Life Sciences, Ltd. announced the expansion of its Phase 2 clinical trial evaluating intranasal foralumab for non-active secondary progressive multiple sclerosis (SPMS).
AI Summary
Tiziana Life Sciences has expanded its Phase 2 clinical trial to study intranasal foralumab, a fully human anti-CD3 monoclonal antibody, for patients with non-active secondary progressive multiple sclerosis (SPMS). This trial targets a significant unmet need, as there are no FDA-approved treatments available for non-active SPMS. The study will now take place at several top-tier research institutions in the Northeastern U.S., including Yale University, Johns Hopkins University, Cornell University, University at Buffalo, University of Massachusetts, and Thomas Jefferson University. All participants will receive their PET scans at a central imaging facility in New Haven, Connecticut, ensuring consistent and reliable data. By expanding the trial, Tiziana aims to generate robust data that could support its regulatory strategy and potentially offer a new, safer approach to controlling inflammation and managing SPMS without causing systemic immune suppression.
Read Announcement- Drug:
- Foralumab
- Announced Date:
- September 19, 2024
- Indication:
- Crohn's disease with decreases in the classic side effects of cytokine release syndrome
Announcement
Tiziana Life Sciences, Ltd announced the National Institutes of Health (NIH), National Institute on Aging have awarded a $4 Million grant to Dr. Howard Weiner as principal investigator at Brigham and Women's Hospital to be the key research site, to study nasal anti-CD3 for the treatment of Alzheimer's disease (AD). .
AI Summary
Tiziana Life Sciences recently received exciting news as the National Institutes of Health’s National Institute on Aging awarded a $4 million grant to support research on nasal anti-CD3 for Alzheimer’s treatment. Dr. Howard Weiner, the principal investigator at Brigham and Women’s Hospital, will lead the study at a key research site. This research will focus on using Tiziana’s intranasal anti-CD3 monoclonal antibody to modulate the immune system, reduce neuroinflammation, and potentially slow the progression of Alzheimer’s disease.
The grant will help advance both preclinical and eventual clinical studies to determine the therapy’s effectiveness. With Alzheimer’s impacting millions of Americans, this new approach could offer a promising option by targeting immune pathways involved in the condition, paving the way for future treatment developments and improved patient outcomes.
Read Announcement- Drug:
- Foralumab
- Announced Date:
- July 24, 2024
- Indication:
- Crohn's disease with decreases in the classic side effects of cytokine release syndrome
Announcement
Tiziana Life Sciences, Ltd. announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its intranasal formulation of foralumab, a fully human anti-CD3 monoclonal antibody, for the treatment of non-active Secondary Progressive Multiple Sclerosis (na-SPMS).
AI Summary
Tiziana Life Sciences has received Fast Track designation from the U.S. FDA for its intranasal formulation of foralumab, a fully human anti-CD3 monoclonal antibody, focused on treating non-active Secondary Progressive Multiple Sclerosis (na-SPMS). This status allows for an expedited review process and more frequent interactions with the FDA, which could help accelerate development and, eventually, patient access to the therapy.
The designation marks an important milestone for Tiziana, highlighting the potential of its innovative intranasal delivery method to reduce neuroinflammation. With limited treatment options available for na-SPMS, this approach could address significant unmet needs in managing neurodegenerative diseases, offering a promising new option for patients with this challenging condition.
Read Announcement- Drug:
- Foralumab
- Announced Date:
- June 26, 2024
- Indication:
- Crohn's disease with decreases in the classic side effects of cytokine release syndrome
Announcement
Tiziana Life Sciences, Ltd announced that the U.S. Food and Drug Administration (FDA) has allowed intranasal foralumab to be used under an Expanded Access (EA) IND in its first patient with moderate Alzheimer's disease.
AI Summary
Tiziana Life Sciences, Ltd. announced that the U.S. Food and Drug Administration (FDA) has permitted the use of intranasal foralumab under an Expanded Access IND for its first patient with moderate Alzheimer’s disease. This decision provides a new treatment option for a patient population that has limited alternatives, even with the availability of anti-amyloid drugs. The treatment is notable due to its intranasal delivery method, which may offer benefits in safety and tolerability compared to traditional injections. Dr. Howard L. Weiner, a principal investigator at the company, expressed optimism that the anti-inflammatory properties of nasal foralumab could help slow the progression of cognitive decline by dampening microglial inflammation, a key factor in Alzheimer’s pathology. Tiziana plans to monitor this initial case closely while preparing to expand studies into a larger Phase 2 trial for early symptomatic Alzheimer’s disease.
Read Announcement- Drug:
- Foralumab
- Announced Date:
- June 11, 2024
- Indication:
- Crohn's disease with decreases in the classic side effects of cytokine release syndrome
Announcement
Tiziana Life Sciences, Ltd. announced it has received acceptance of its submission for intranasal foralumab to receive Fast Track Designation approval for the treatment of non-active, secondary-progressive multiple sclerosis (na-SPMS) to the U.S. Food and Drug Administration (FDA).
AI Summary
Tiziana Life Sciences, Ltd. announced that the U.S. Food and Drug Administration (FDA) has accepted its submission for intranasal foralumab, aiming for Fast Track Designation to treat non-active, secondary-progressive multiple sclerosis (na-SPMS). This fast track status is intended for drugs that treat serious conditions with unmet medical needs, potentially expediting the review process by providing more frequent interactions with the FDA during development.
The company’s submission, based on encouraging data from an Expanded Access Program, demonstrated that intranasal foralumab helped reduce fatigue and maintain disease stability in na-SPMS patients. If granted, the Fast Track Designation would make foralumab the only monoclonal antibody for na-SPMS administered intranasally, offering a convenient alternative compared to the traditional intravenous or subcutaneous dosing methods. This milestone strengthens Tiziana’s efforts in developing innovative immunomodulation therapies for neurodegenerative diseases.
Read Announcement- Drug:
- Foralumab
- Announced Date:
- May 13, 2024
- Indication:
- Crohn's disease with decreases in the classic side effects of cytokine release syndrome
Announcement
Tiziana Life Sciences, Ltd. announced it has submitted an FDA request to obtain Orphan Drug Designation for intranasal foralumab for the treatment of non-active secondary progressive Multiple Sclerosis (na-SPMS).
AI Summary
Tiziana Life Sciences, Ltd. announced that it has submitted an FDA request for Orphan Drug Designation for its intranasal foralumab. This treatment is aimed at non-active secondary progressive multiple sclerosis (na-SPMS), a form of the disease that currently has few effective treatment options. If granted, the Orphan Drug Designation could give Tiziana several benefits, such as market exclusivity and a streamlined development process.
The submission is an important step for the company as it strives to bring innovative therapy options to patients with na-SPMS. The request highlights Tiziana’s commitment to developing new treatments that address the unique needs of patients suffering from this challenging condition. The FDA's evaluation of their request will be closely watched as it could potentially accelerate research and provide hope for improved disease management in the future.
Read Announcement- Drug:
- Foralumab
- Announced Date:
- April 23, 2024
- Indication:
- Crohn's disease with decreases in the classic side effects of cytokine release syndrome
Announcement
Tiziana Life Sciences, Ltd announced that the U.S. Food and Drug Administration (FDA) has allowed its intranasal foralumab non-active Secondary Progressive Multiple Sclerosis (na-SPMS) Expanded Access (EA) Program to expand from 10 patients to a total of 30 patients.
AI Summary
Tiziana Life Sciences announced that the U.S. Food and Drug Administration (FDA) has approved expanding its Expanded Access (EA) Program for intranasal foralumab in treating non-active Secondary Progressive Multiple Sclerosis (na-SPMS). The program is set to increase the number of patients from 10 to 30, allowing more individuals access to this innovative treatment option.
Initial results from the first 10 patients have been encouraging, with participants experiencing stable or improved clinical outcomes. Notably, some patients have been on treatment for over one year, while others have been dosed for approximately six months, all without serious side effects. Additionally, nearly 70% of these patients reported improvements in fatigue. The expansion provides an alternative treatment pathway for na-SPMS patients who are not eligible for the Phase 2a trial, highlighting Tiziana’s commitment to offering new therapeutic choices where limited options exist.
Read Announcement
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