This section highlights FDA-related milestones and regulatory updates for drugs developed by Aditxt (ADTX).
Over the past two years, Aditxt has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ADI-100 and Mitomic®. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ADI-100 - FDA Regulatory Timeline and Events
ADI-100 is a drug developed by Aditxt for the following indication: Rejection of transplanted organs, skin allografting, autoimmune diseases and allergies.
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:
- ADI-100
- Announced Date:
- April 14, 2025
- Indication:
- Rejection of transplanted organs, skin allografting, autoimmune diseases and allergies
Announcement
Aditxt, Inc announced that a recently completed study conducted by the Mayo Clinic further validates the preclinical findings of ADI-100, the lead therapeutic candidate developed by Aditxt's wholly owned subsidiary, Adimune™, Inc. ("Adimune").
AI Summary
A recent study at the Mayo Clinic has further validated the preclinical findings for ADI-100, the lead therapeutic candidate developed by Adimune, Inc., a wholly owned subsidiary of Aditxt, Inc. The study, led by experts in neuroimmunology, confirmed that ADI-100 can induce immune tolerance to glutamic acid decarboxylase (GAD). GAD is an autoantigen involved in various autoimmune diseases, such as type 1 diabetes and stiff person syndrome.
The research showed that ADI-100 has an encouraging safety profile, as it did not increase T cell reactivity to GAD. It also demonstrated immune modulation at the cellular level, with dendritic cells showing increased tolerogenic markers. These findings support the continued development of ADI-100 for its potential to offer targeted treatments by safely restoring immune tolerance in patients with autoimmune conditions.
Read Announcement- Drug:
- ADI-100
- Announced Date:
- March 6, 2025
- Indication:
- Rejection of transplanted organs, skin allografting, autoimmune diseases and allergies
Announcement
Aditxt, Inc today provided an update on its subsidiary, Adimune, Inc., ("Adimune") and its progress in advancing ADI-100, an investigational product candidate to be studied in patients with Psoriasis, Type I Diabetes (T1D) and Stiff Person Syndrome.
AI Summary
Aditxt, Inc. provided an update on its subsidiary, Adimune, Inc., and the advancement of its investigational product candidate, ADI-100. This therapy is designed to treat patients with Psoriasis, Type I Diabetes (T1D), and Stiff Person Syndrome by restoring immune tolerance instead of suppressing the immune system. Adimune aims to address the root causes of autoimmune diseases through its innovative immune modulation technology. All preclinical studies for ADI-100 have been completed, and drug substance shipments for final formulation are planned for March. The preclinical data support the product's potential effectiveness over a 10-month duration in T1D study models, showing safety, no toxicity, and no harmful immune interference. By successfully manufacturing GMP clinical-grade drug substances and progressing vital drug product release assays, the company is preparing to advance ADI-100 into human clinical trials, marking a significant milestone in its mission to transform autoimmune disease treatment.
Read Announcement- Drug:
- ADI-100
- Announced Date:
- December 12, 2024
- Indication:
- Rejection of transplanted organs, skin allografting, autoimmune diseases and allergies
Announcement
Aditxt, Inc announced that its subsidiary, Adimune, Inc. ("Adimune"), has successfully completed all preclinical efficacy and safety studies for its antigen-specific gene therapy, ADI-100.
AI Summary
Aditxt, Inc announced a significant milestone in the development of its antigen-specific gene therapy, ADI-100, as its subsidiary Adimune, Inc. successfully completed all preclinical efficacy and safety studies. These studies showed that ADI-100 can restore immune tolerance in autoimmune diseases without weakening the body’s overall ability to fight infections or tumors. In preclinical models, the therapy reversed high blood sugar in Type 1 Diabetes, preserved islet cell mass, and provided long-lasting protection. Additionally, toxicology tests confirmed a favorable safety profile with no adverse effects or retention of plasmid material in tissues. With these promising results, Adimune is preparing to submit a Clinical Trial Application or Investigational New Drug application to begin first-in-human clinical trials. This advancement marks an important step toward transforming treatment options for autoimmune diseases such as Type 1 Diabetes, Psoriasis, and Stiff-Person Syndrome.
Read Announcement
Mitomic® Endometriosis Test - FDA Regulatory Timeline and Events
Mitomic® Endometriosis Test is a drug developed by Aditxt for the following indication: For Endometriosis.
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:
- Mitomic® Endometriosis Test
- Announced Date:
- April 16, 2025
- Indication:
- For Endometriosis
Announcement
Aditxt, Inc. announced that its subsidiary, Pearsanta, Inc. ("Pearsanta"), has received Institutional Review Board (IRB) approval from WCG Clinical to initiate a prospective clinical study evaluating the Mitomic® Endometriosis Test (MET), a novel blood-based diagnostic designed to aid in the early detection of endometriosis.
AI Summary
Aditxt, Inc. announced that its subsidiary, Pearsanta, Inc., has received Institutional Review Board (IRB) approval from WCG Clinical to start a prospective clinical study. The study will evaluate the Mitomic® Endometriosis Test (MET), a new blood-based diagnostic tool designed to help detect endometriosis early. Instead of relying solely on the invasive laparoscopic procedures currently used as the gold standard for diagnosis, MET aims to offer a non-invasive alternative by identifying mitochondrial DNA deletions in blood samples.
The study will compare the performance of MET to traditional laparoscopic methods in up to 1,000 women referred for surgery. Participants will complete a symptom questionnaire and provide a pre-operative blood sample. Enrollment is scheduled to begin in May 2025. Pearsanta hopes that this research will generate real-world data to demonstrate MET's accuracy and effectiveness in detecting endometriosis, potentially paving the way for quicker and more accessible diagnosis.
Read Announcement- Drug:
- Mitomic® Endometriosis Test
- Announced Date:
- April 16, 2025
- Estimated Event Date Range:
- May 1, 2025 - May 31, 2025
- Target Action Date:
- May 01, 2025
- Indication:
- For Endometriosis
Announcement
Aditxt, Inc announced that Patient enrollment is expected to begin in May 2025.
AI Summary
Aditxt has announced a new clinical study to evaluate the Mitomic® Endometriosis Test (MET), a blood-based diagnostic tool that may offer a non-invasive alternative to current surgical methods. The study will compare MET’s performance against diagnostic laparoscopy, the traditional gold standard for confirming endometriosis. Up to 1,000 participants, all of whom are referred for laparoscopic procedures, will join the trial. Each participant will fill out a symptom questionnaire and provide a pre-operative blood sample to help gather real-world data on the test’s accuracy. Patient enrollment for the study is expected to begin in May 2025. By targeting mitochondrial DNA deletions, the MET aims to reduce the delay in diagnosis and offer earlier, more accessible detection for women with endometriosis, potentially improving treatment and outcomes.
Read Announcement
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