This section highlights FDA-related milestones and regulatory updates for drugs developed by MediciNova (MNOV).
Over the past two years, MediciNova has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
MN-001, MN166, and MN-166. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
MN-001 (tipelukast) - FDA Regulatory Timeline and Events
MN-001 (tipelukast) is a drug developed by MediciNova for the following indication: Triglyceride Metabolism.
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:
- MN-001 (tipelukast)
- Announced Date:
- May 28, 2024
- Indication:
- Triglyceride Metabolism
Announcement
MediciNova, Inc announced that MediciNova conducted two poster presentations at the 92nd European Atherosclerosis Society (EAS) 2024 Congress held online May 26-29, 2024.
AI Summary
MediciNova, Inc. recently announced that it presented two poster sessions at the 92nd European Atherosclerosis Society (EAS) 2024 Congress, held online from May 26-29, 2024. The presentations focused on advancing research into cardiovascular and liver health. One poster, led by Chief Medical Officer Dr. Kazuko Matsuda, provided an update on the ongoing Phase 2 clinical study evaluating the efficacy, safety, and tolerability of MN-001 (Tipelukast) in subjects with non-alcoholic fatty liver disease (NAFLD). The presentation detailed the clinical background, study design, objectives, and current enrollment statistics.
In another presentation, Dr. Huicheng Qi showcased data on MN-002, the active metabolite of MN-001, which demonstrated promising results in enhancing both ApoA1- and HDL-mediated cholesterol efflux. These findings highlight potential benefits in promoting healthy cholesterol transport and support MediciNova’s commitment to innovative solutions in managing lipid metabolism and related diseases.
Read Announcement
MN166 - FDA Regulatory Timeline and Events
MN166 is a drug developed by MediciNova for the following indication: In Amyotrophic Lateral Sclerosis (ALS).
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:
- MN166
- Announced Date:
- September 30, 2024
- Indication:
- In Amyotrophic Lateral Sclerosis (ALS)
Announcement
MediciNova, Inc announced that the National Institutes of Health (NIH) - Neurological Disorders and Stroke (NINDS) has awarded $22 million for an intermediate size Expanded Access Protocol (EAP) to evaluate the efficacy of MN-166 (ibudilast) in Amyotrophic Lateral Sclerosis (ALS)1,2. I
AI Summary
MediciNova, Inc. announced that the National Institutes of Health’s National Institute of Neurological Disorders and Stroke (NINDS) has awarded $22 million for an Expanded Access Protocol (EAP). This initiative is designed to evaluate the effectiveness of MN-166 (ibudilast) in treating Amyotrophic Lateral Sclerosis (ALS). Through this trial, MediciNova will work with an academic group to provide MN-166 along with regulatory and safety monitoring support. The EAP, which falls under the FDA’s Compassionate Use guidelines, will allow around 200 ALS patients who are not eligible for the COMBAT-ALS trial to receive MN-166 treatment. The study will focus on clinical outcomes and levels of neurofilament light, a biomarker for nerve damage. This significant funding is supported by the Accelerating Access to Critical Therapies for ALS Act and represents a promising step toward improved treatment options for ALS patients.
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MN-166 (ibudilast) - FDA Regulatory Timeline and Events
MN-166 (ibudilast) is a drug developed by MediciNova for the following indication: Inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines.
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:
- MN-166 (ibudilast)
- Announced Date:
- April 8, 2025
- Indication:
- Inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines
Announcement
MediciNova, Inc announced enrollment of the first patient in the NIH-funded Expanded Access Program (EAP) trial to evaluate MN-166 (ibudilast) in patients with Amyotrophic Lateral Sclerosis (ALS).
AI Summary
MediciNova, Inc. announced an important step forward by enrolling the first patient in an NIH-funded Expanded Access Program (EAP) trial. This trial will evaluate MN-166 (ibudilast) in patients with Amyotrophic Lateral Sclerosis (ALS) and is specifically designed for individuals who are not eligible for the ongoing Phase 2/3 COMBAT-ALS trial. The EAP trial, supported by the National Institutes of Health and its Neurological Disorders and Stroke division, will include around 200 ALS patients, aiming to assess both the safety and potential benefits of MN-166.
This initiative represents a significant commitment by MediciNova to make promising new therapies accessible to ALS patients in advanced stages of the disease. The trial seeks to provide additional treatment options and hope for those facing limited alternatives, reinforcing the company’s dedication to developing innovative treatments for neurodegenerative disorders.
Read Announcement- Drug:
- MN-166 (ibudilast)
- Announced Date:
- December 5, 2024
- Indication:
- Inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines
Announcement
MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market announces the study update and interim analysis results from the Company's COMBAT-ALS Phase 2b/3 clinical trial of MN-166 (ibudilast) in Amyotrophic Lateral Sclerosis (ALS) will be presented at the 35th International Symposium on ALS/MND held December 6-8, 2024 in Montreal, Canada.
AI Summary
MediciNova, Inc., traded on the NASDAQ Global Market, announced that it will present an update and interim analysis from its COMBAT-ALS Phase 2b/3 clinical trial of MN-166 (ibudilast) in ALS at the 35th International Symposium on ALS/MND in Montreal, Canada from December 6 to 8, 2024. The study update highlights that over 200 patients have been enrolled, with 183 participants assigned to either MN-166 or placebo. An interim analysis showed strong positive correlations between 6-month and 12-month data for key clinical measures, including CAFS, modified CAFS, and ALSFRS-R scores. These promising interim results, confirmed by an independent Data Safety Monitoring Board, support continuing the trial as planned. The presentation is expected to provide important insights into treatment designs for rapidly progressing diseases like ALS.
Read Announcement- Drug:
- MN-166 (ibudilast)
- Announced Date:
- September 9, 2024
- Indication:
- Inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines
Announcement
MediciNova, announced that an abstract regarding a clinical trial of MN-166 (ibudilast) in the treatment of Amyotrophic Lateral Sclerosis (ALS), COMBAT-ALS study has been selected for a poster presentation at the 35th International Symposium on ALS / MND to be held December 6-8, 2024 in Montreal, Canada.
AI Summary
MediciNova announced that an abstract from its COMBAT-ALS clinical trial has been accepted for a poster presentation at the 35th International Symposium on ALS/MND. The event will take place in Montreal, Canada, from December 6-8, 2024. The poster, titled “COMBAT-ALS Phase 2b/3 Trial of MN-166 (Ibudilast) in ALS: Trial Update and Interim Analysis Results,” will present trial updates on MN-166, a small molecule designed to treat amyotrophic lateral sclerosis (ALS). Dr. Björn Oskarsson, the lead principal investigator and an Associate Professor of Neurology, will present the findings. This abstract selection highlights MediciNova’s ongoing efforts in researching neurodegenerative diseases and their commitment to advancing treatments for ALS.
Read Announcement- Drug:
- MN-166 (ibudilast)
- Announced Date:
- September 3, 2024
- Indication:
- Inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines
Announcement
MediciNova, Inc. announced that an abstract was accepted for presentation regarding a clinical trial of MN-166 (ibudilast) in Amyotrophic Lateral Sclerosis (ALS), COMBAT-ALS Phase 2b/ 3 study at the 2024 Annual NEALS Meeting to be held October 21-24, 2024 (a hybrid meeting in Clearwater, Florida and Online).
AI Summary
MediciNova, Inc. announced that an abstract detailing its COMBAT-ALS Phase 2b/3 trial of MN-166 (ibudilast) in treating amyotrophic lateral sclerosis (ALS) has been accepted for presentation. The study focuses on the safety and effectiveness of MN-166, a small molecule that targets inflammatory processes linked to ALS and other neurodegenerative diseases. The poster presentation will be led by Principal Investigator Dr. Björn Oskarsson, Associate Professor of Neurology and Director of the ALS Center of Excellence in Jacksonville, Florida. The presentation is set for October 23, 2024, as part of the 2024 Annual NEALS Meeting, a hybrid event held both online and in Clearwater, Florida, from October 21-24, 2024. This opportunity aims to share important updates on the trial design and progress, offering insights into potential new treatments for ALS.
Read Announcement- Drug:
- MN-166 (ibudilast)
- Announced Date:
- August 29, 2024
- Indication:
- Inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines
Announcement
MediciNova, Inc announces that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a pending patent application, which covers MN-166 (ibudilast) for post-COVID conditions.
AI Summary
MediciNova, Inc. announced that the U.S. Patent and Trademark Office has issued a Notice of Allowance for its pending patent application covering MN-166 (ibudilast), specifically for treating post-COVID conditions. This patent focuses on using ibudilast at therapeutic doses to help relieve a range of post-COVID symptoms, such as anxiety, depression, fatigue, shortness of breath, and other related issues.
The patent covers different methods of administering the treatment—including oral, intravenous, subcutaneous, intramuscular, and inhalation routes—and it allows the drug to be used alone or combined with other medications like corticosteroids and NSAIDs. The protection provided by the patent is anticipated to continue until no earlier than November 2042, which will help MediciNova maintain its market exclusivity while addressing the ongoing health challenges faced by patients post-COVID.
Read Announcement- Drug:
- MN-166 (ibudilast)
- Announced Date:
- June 5, 2024
- Indication:
- Alcohol Use Disorder
Announcement
MediciNova, Inc announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a pending patent application which covers MN-166 (ibudilast) for the prevention of metastasis in various cancers including pancreatic cancer, lung cancer, breast cancer, colorectal cancer, melanoma, and ovarian cancer.
AI Summary
MediciNova, Inc. recently announced that it received a Notice of Allowance from the U.S. Patent and Trademark Office for a pending patent application involving its drug MN-166 (ibudilast). This patent, which is expected to expire no earlier than July 2042, covers the use of MN-166 for preventing metastasis in several types of cancer, including pancreatic, lung, breast, colorectal, melanoma, and ovarian cancers.
The allowed claims permit the use of MN-166 in combination with other therapies such as chemotherapy, immunotherapy, radiotherapy, and additional treatments. They also cover different methods of oral administration, various doses, dosing frequencies, and treatment durations. This move strengthens MediciNova’s intellectual property portfolio and highlights the potential of MN-166 in preventing the spread of solid tumors in cancer patients.
Read Announcement- Drug:
- MN-166 (ibudilast)
- Announced Date:
- June 3, 2024
- Indication:
- Alcohol Use Disorder
Announcement
MediciNova, Inc., announced that MediciNova's collaborator, Gilbert Youssef, M.D. at Harvard Medical School, Attending Physician, Center for Neuro-Oncology at Dana-Farber Cancer Institute and Brigham and Women's Hospital, presented new data and results of a Phase 1b/2a Clinical Trial of MN-166 (ibudilast) in Glioblastoma (GBM) at the American Society of Clinical Oncology (ASCO) Annual meeting 2024 held May 31- June 4th in Chicago, IL.
AI Summary
MediciNova, Inc. announced that its collaborator, Dr. Gilbert Youssef from Harvard Medical School and Dana-Farber Cancer Institute, presented new data from a clinical trial at the ASCO Annual Meeting 2024 in Chicago. The Phase 1b/2a trial tested MN‐166 (ibudilast) combined with temozolomide (TMZ) in patients with glioblastoma (GBM). The study involved 62 patients, with both newly diagnosed and recurrent GBM. The main goals were to examine safety, tolerability, and the effectiveness of the combination treatment. The results showed that the treatment was safe and well tolerated, with no unexpected side effects. The trial provided encouraging safety data and promising efficacy results, helping support further research into MN‐166 as a treatment option for GBM.
Read Announcement- Drug:
- MN-166 (ibudilast)
- Announced Date:
- May 20, 2024
- Indication:
- Alcohol Use Disorder
Announcement
MediciNova, Inc announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a pending patent application which covers MN-166 (ibudilast) for the prevention of metastasis of eye cancer.
AI Summary
MediciNova, Inc. has received a Notice of Allowance from the U.S. Patent and Trademark Office for its pending patent application covering MN-166 (ibudilast) for preventing metastasis in eye cancer. This patent, once issued and set to expire no earlier than July 2042, will protect the use of MN-166 in reducing the spread of eye cancer, particularly uveal melanoma. The allowed claims include methods to prevent, ameliorate, or minimize cancer metastasis through various oral doses, dosing frequencies, and treatment lengths. This intellectual property milestone strengthens the company’s position in oncology, as the patent may enhance the potential value and future development of MN-166 as a treatment option. The move underscores MediciNova's commitment to expanding therapeutic approaches to combat cancer metastasis and ultimately address the challenges in treating eye cancer.
Read Announcement- Drug:
- MN-166 (ibudilast)
- Announced Date:
- May 14, 2024
- Indication:
- Alcohol Use Disorder
Announcement
MediciNova, Inc announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a pending patent application which covers MN-166 (ibudilast) for the treatment of chlorine-induced acute respiratory distress syndrome (ARDS).
AI Summary
MediciNova, Inc. announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office. This allowed notice covers a pending patent application for MN-166 (ibudilast), specifically for the treatment of chlorine-induced acute respiratory distress syndrome (ARDS). The notice marks an important milestone for the company as it protects proprietary technology aimed at managing a severe respiratory condition. Securing this patent is expected to strengthen MediciNova’s market position and support further development in addressing critical drug safety and treatment challenges.
The company’s progress in protecting its innovation highlights its commitment to advancing therapeutic options for patients suffering from ARDS, a life-threatening condition that arises after exposure to chlorine. This development reflects MediciNova’s efforts to secure its intellectual property rights as it moves forward with its research and treatment strategies.
Read Announcement- Drug:
- MN-166 (ibudilast)
- Announced Date:
- May 7, 2024
- Indication:
- Alcohol Use Disorder
Announcement
MediciNova, Inc., announced that it has received an issue notification from the U.S. Patent and Trademark Office for a new patent which covers extended-release oral formulations of MN-166 (ibudilast).
Read Announcement
