A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of MN-001 in Patients Diagnosed With Non-alcoholic Fatty Liver Disease, Type 2 Diabetes Mellitus, and Hypertriglyceridemia

The design of the Phase 2 clinical trial includes the following elements:
Multi-center, two-arm, randomized, double-blind, placebo-controlled trial to evaluate MN-001 (tipelukast) vs. placebo in approximately 40 patients in the U.S.
Patients will be randomized 1:1 to receive either 500 mg/day of MN-001 (tipelukast) or placebo for 24 weeks.
The co-primary endpoints are (1) change from baseline in liver fat content measured by controlled attenuation parameter (CAP) score at Week 24, and (2) change from baseline in fasting serum triglycerides at Week 24. FebroScan is a non-invasive, quantitative, and accurate measure of liver fat content commonly used in early phase trials to measure treatment response.
Secondary endpoints include safety and tolerability and changes in lipid profile (HDL-C, LDL-C, and total cholesterol).

Start Date22 Aug 2022

Sponsor / Collaborator

MediciNova, Inc.

NCT02503657 / CompletedPhase 2

A Randomized, Placebo-Controlled, Double-Blind Six Month Study Followed by an Open-Label Extension Phase to Evaluate the Efficacy, Safety and Tolerability of MN-001 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

This is a randomized, placebo-controlled, double-blind, 6-month study followed by a 6 month open-label extension phase to evaluate the efficacy, safety, and tolerability of MN-001 in moderate to severe IPF patients. MN-001 750 mg or matching placebo will be orally administered twice daily over a 26 week period in subjects with a confirmed diagnosis of IPF per the ATS )American Thoracic Society) 2011 Guidelines. Approximately 15 subjects are planned to be enrolled. This study will consist of two treatment arms, MN-001 and matching placebo. Randomization will occur in a 2:1 ratio (MN-001: placebo). Eligible subjects will consist of males and females ranging in age from 21 to 80 years old, inclusive.
The study will consist of a Screening Phase (up to 3 months prior to Day1) followed by a 26 week double-blind Treatment Phase, a 26 week Open-Label Extension (OLE) phase and a Follow-up Visit (within 4 weeks after the last dose).

Start Date09 Mar 2016

Sponsor / Collaborator

MediciNova, Inc.

NCT02681055 / CompletedPhase 2

An Open-Label Study To Evaluate The Efficacy, Safety, Tolerability and PK of MN-001 (Tipelukast) on HDL Function and Serum Triglyceride Levels in NASH and Non-Alcoholic Fatty Liver Disease (NAFLD) Subjects With Hypertriglyceridemia

This is a multi-center, proof-of-principle, open-label study designed to evaluate the efficacy, safety, and tolerability of MN-001 in non-alcoholic steatohepatitis (NASH) and Non-Alcoholic Fatty Liver Disease (NAFLD) subjects with hypertriglyceridemia.

Start Date01 Mar 2016

Sponsor / Collaborator

MediciNova, Inc.

100 Clinical Results associated with Tipelukast

100 Translational Medicine associated with Tipelukast

100 Patents (Medical) associated with Tipelukast

Literatures (Medical) associated with Tipelukast

01 Jun 2007·Methods and findings in experimental and clinical pharmacology

Gateways to clinical trials.

Article

Author: Prous, J R ; Rabasseda, X ; Bayés, M

101M, 12B75; ABT-869, Agomelatine, Alvocidib hydrochloride, Amb a 1 ISS-1018, AMG-386, Andolast, AP-23573, Arsenic trioxide, ATI-7505; BAY-68-4986, Berberine chloride, BNP-1350, BrachySil, Brostallicin hydrochloride; Caldaret hydrate, Cancer vaccine, Cediranib, CHAMPION everolimus-eluting coronary stent, CP-751871; D-4F, Degarelix acetate, Dofequidar fumarate; Ecogramostim, Enzastaurin hydrochloride, Etaracizumab, Everolimus; Fluticasone furoate; Glucarpidase; Hochuekki-to, Human papillomavirus vaccine; Icatibant acetate, INO-1001, Interleukin-21, Irofulven, ISIS-301012, Ixabepilone; KRN-951; Lacosamide; Mecasermin, Mecasermin rinfabate, Mepolizumab, Mesna disulfide, m-NO-ASA; Nematode anticoagulant protein c2, Nilotinib, Nolatrexed dihydrochloride; O6-Benzylguanine; Pemetrexed disodium, Perifosine, Pertuzumab, Plitidepsin, Prasterone, PRO-2000/5, PX-12, Pyridoxal phosphate; Recombinant human soluble thrombomodulin, Retapamulin, Rinfabate, Rubitecan; Seliciclib, SR-271425, STA-4783; T- 2000, Telatinib, Temsirolimus, Terameprocol, Teverelix, Ticagrelor, Tipelukast, Tirapazamine; Uracil; Valspodar, Vatalanib succinate, Velimogene aliplasmid, Vitespen, Volociximab; XL-184.

01 Jan 2000·Prostaglandins & Other Lipid MediatorsQ3 · BIOLOGY

No involvement of lipid mediators in a guinea pig model of ultrasonically nebulized distilled water-induced bronchoconstriction

Q3 · BIOLOGY

Article

Author: Tamotsu Matsuda ; Yoshihisa Ishiura ; Shigeharu Myou ; Tokunao Amemiya ; Masaki Fujimura

An inhalation of ultrasonically nebulized distilled water (UNDW) induces bronchoconstriction only in asthmatics, but the mechanism underlying the response is not fully understood. We have reported that bronchoconstriction occurs immediately after UNDW is inhaled 20 min after an antigen challenge in guinea pigs. Our aim was to examine the role of lipid mediators in this response. Passively sensitized guinea pigs were anesthetized and artificially ventilated. A sulfidopeptide leukotriene receptor antagonist, KCA-757, and platelet-activating factor antagonists, Y-24180 and E6123, were administered i.v. 15 min after an aerosolized antigen challenge, and UNDW was inhaled 5 min later. KCA-757, Y-24180, or E6123 did not, significantly alter the UNDW-induced bronchoconstriction. Together with our previous data that thromboxane A2 receptor antagonists did not influence the UNDW-induced bronchoconstriction, the present results suggest that lipid mediators are not involved in the UNDW-induced bronchoconstriction in our guinea pig model.

01 Oct 1997·Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology

Role of leukotrienes in post-allergic propranolol-induced bronchoconstriction in guinea-pigs.

Article

Author: Matsuda, T ; Fujimura, M ; Myou, S ; Songür, N ; Mizuhashi, K ; Ishiura, Y

BACKGROUNDAdministration of propranolol can provoke bronchoconstriction only in asthmatic patients. Recently we developed an animal model for propranolol-induced bronchoconstriction (PIB). Our working hypothesis is that such bronchoconstriction may result from the inflammatory mediators released by an allergic reaction.OBJECTIVESOur goal in this study was to determine which products of arachidonate 5-lipoxygenase pathway are involved in the PIB.METHODSPropranolol at a concentration of 10 mg/mL was inhaled 20 min after antigen challenge in passively sensitized, anaesthetized and artificially ventilated guinea-pigs. Two different sulfidopeptide leukotriene (s-LT) antagonists, ICI198 615 in the doses of 0.03 and 0.3 mg/kg and vehicle and KCA757 in the doses of 1 and 5 mg/kg and vehicle, and a LTB4 antagonist ONO4057 in the doses of 1 and 10 mg/kg and vehicle were injected intravenously 15 min after antigen challenge. Effects of an anticholinergic agent atropine sulphate (5mg/kg) and an alpha-adrenergic blocker phentolamine (0.3 and 3 mg/kg) were examined in the same way.RESULTSBronchoconstriction occurred when 10 mg/mL of propranolol was inhaled 20 min after antigen challenge. Both ICI198 615 and KCA757 administered intravenously 15 min after antigen challenge reduced the PIB in a dose-dependent manner while ONO4057 did not alter the PIB. Atropine or phentolamine did not change the PIB.CONCLUSIONSThese results suggest that mediator mechanism, but not cholinergic or alpha-adrenergic nerve, is important in the PIB which developed after the allergic bronchoconstriction in our guinea-pig model and that s-LTs but not LTB4 have an important role in the pathophysiology of the PIB.

News (Medical) associated with Tipelukast

14 Nov 2024

·www.globenewswire.com

MediciNova Receives Notice of Allowance from United States Patent and Trademark Office for New Patent Covering MN-001 for Triglyceride Synthesis in the Liver

LA JOLLA, Calif., Nov. 14, 2024 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), announces that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a pending patent application for MN-001 (Tipelukast) to cover "Method to Decrease Triglyceride Synthesis in a Liver of a Subject." The allowed claims cover a groundbreaking method for decreasing triglyceride synthesis in the liver by administering MN-001 (Tipelukast) or its metabolite or pharmaceutically acceptable salt. This method is particularly beneficial for subjects diagnosed with insulin resistance, pre-diabetes, or diabetes. Once issued, this patent is expected to expire no earlier than May 26, 2042. Key Claims of the Patent Include: Method：Method to Decrease Triglyceride Synthesis in the liver;Formulations: MN-001 (Tipelukast) can be administered in various forms;Administration: The compound can be administered orally, in various formulations; andDosage Flexibility: The compound can be administered in a range of different dosing frequencies. Kazuko Matsuda, M.D., Ph.D., M.P.H., MediciNova’s Chief Medical Officer commented, ” We are excited to receive this Notice of Allowance, which underscores our commitment to developing innovative and proprietary treatments for metabolic disorders. This patent represents a significant advancement in our efforts to provide safe and effective therapies for patients with insulin resistance, pre-diabetes, and diabetes.” The Notice of Allowance is a critical step towards the issuance of the patent, which will provide MediciNova with intellectual property protection for this novel method of treatment. This achievement highlights the company's dedication to advancing medical science and improving patient outcomes. About MN-001 MN-001 (tipelukast) is a novel, orally bioavailable, small molecule compound thought to exert its effects through several mechanisms to produce its anti-inflammatory and anti-fibrotic activity in preclinical models, including leukotriene (LT) receptor antagonism, inhibition of phosphodiesterases (PDE) (mainly 3 and 4), and inhibition of 5-lipoxygenase (5-LO). The 5-LO/LT pathway has been postulated as a pathogenic factor in fibrosis development, and MN-001's inhibitory effect on 5-LO and the 5-LO/LT pathway is a novel approach to treat fibrosis. MN-001 has been shown to down-regulate expression of genes that promote fibrosis including LOXL2, Collagen Type 1 and TIMP-1. MN-001 has also been shown to down-regulate expression of genes that promote inflammation including CCR2 and MCP-1. In addition, MN-001 was found to inhibit triglyceride synthesis in hepatocytes by inhibiting arachidonic acid uptake. About NAFLD, Type 2 Diabetes Mellitus (T2DM), and Hypertriglyceridemia NAFLD is considered the hepatic manifestation of metabolic syndrome; studies have reported that 50% of patients with metabolic syndrome also have NAFLD. There is sufficient clinical and epidemiological evidence supporting the assertion that NAFLD is strongly associated with an increased prevalence and incidence of cardiovascular disease, T2DM, chronic kidney disease, and malignancy. The presence of dyslipidemia (hypercholesterolemia, hypertriglyceridemia, or both) is reported in 20 - 80% of NAFLD cases. About MediciNova MediciNova, Inc. is a clinical-stage biopharmaceutical company developing a broad late-stage pipeline of novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases. Based on two compounds, MN-166 (ibudilast) and MN-001 (tipelukast), with multiple mechanisms of action and strong safety profiles, MediciNova has 11 programs in clinical development. MediciNova’s lead asset, MN-166 (ibudilast), is currently in Phase 3 for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM) and is Phase 3-ready for progressive multiple sclerosis (MS). MN-166 (ibudilast) is also being evaluated in Phase 2 trials in Long COVID and substance dependence. MN-001 (tipelukast) was evaluated in a Phase 2 trial in idiopathic pulmonary fibrosis (IPF) and a second Phase 2 trial in non-alcoholic fatty liver disease (NAFLD) is ongoing. MediciNova has a strong track record of securing investigator-sponsored clinical trials funded through government grants. Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the future development and efficacy of MN-166, MN-001, MN-221, and MN-029. These forward-looking statements may be preceded by, followed by, or otherwise include the words "believes," "expects," "anticipates," "intends," "estimates," "projects," "can," "could," "may," "will," "would," “considering,” “planning” or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, risks of obtaining future partner or grant funding for development of MN-166, MN-001, MN-221, and MN-029 and risks of raising sufficient capital when needed to fund MediciNova's operations and contribution to clinical development, risks and uncertainties inherent in clinical trials, including the potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, product development and commercialization risks, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, risks associated with the reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials, and the timing of expected filings with the regulatory authorities, MediciNova's collaborations with third parties, the availability of funds to complete product development plans and MediciNova's ability to obtain third party funding for programs and raise sufficient capital when needed, and the other risks and uncertainties described in MediciNova's filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2023 and its subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements. INVESTOR CONTACT: David H. Crean, Ph.D.Chief Business OfficerMediciNova, Incinfo@medicinova.com

Phase 2Phase 3

11 Nov 2024

·www.globenewswire.com

MediciNova Given Notice of Monetary Damages Due Under Patent Settlement of Sanofi-Novartis

LA JOLLA, Calif., Nov. 11, 2024 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ: MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that it was notified by Sanofi that the Sanofi/Novartis litigation was settled. Accordingly, MediciNova is entitled to receive a certain amount of monetary damages through this settlement. Further details will be provided as they become available. Yuichi Iwaki, M.D., Ph.D., MediciNova CEO commented, “The successful resolution of the Sanofi-Novartis litigation and the resulting monetary damages due to MediciNova both validates the value of our intellectual property and provides an additional source of non-dilutive funding, which we plan to apply to supporting our ongoing clinical development programs, particularly our late-stage pipeline targeting inflammatory, metabolic, and neurodegenerative diseases. This outcome further reinforces our commitment to developing unique assets with long-term value. We remain dedicated to preserving our financial position as we continue to prudently advance our novel small molecule therapies towards commercialization." About Sanofi/Novartis litigation On March 30,2022, MediciNova, Inc. was notified that Genzyme Corporation, a subsidiary of Sanofi, filed its First Amended Complaint, which included a claim for infringement of U.S. Patent No. 9,051,542, on February 23, 2022 in a lawsuit previously filed against Novartis Gene Therapies, Inc., Novartis Pharmaceutical Corporation, and Novartis AG in the U.S. District Court for the District of Delaware. This patent, among others was included in the assignment Agreement dated December 19, 2005, between MediciNova, Inc., as successor in interest to Avigen, Inc. and Genzyme Corporation. The plaintiffs allege that the defendants infringe certain U.S. patents through the unauthorized manufacture, use, and sale of recombinant adeno-associated virus vectors (“rAAV vectors”) for their gene therapy drug Zolgensma. If Genzyme recovers any monetary damages, by way of settlement or otherwise, as a result of this litigation, then MediciNova is entitled to receive a certain portion of such monetary damages from Genzyme as per the terms of assignment agreement. About Zolgensma The U.S. Food and Drug Administration (FDA) approved Zolgensma (onasemnogene abeparvovec-xioi) on May 24, 2019. Zolgensma is a gene therapy that treats children under two years old with spinal muscular atrophy (SMA). It was the first gene therapy approved by the FDA to treat a disease. Novartis priced an infusion at $2.1 million, making it one of the priciest medicines on the market. Zolgensma has become one of Novartis’ top-sellers, generating more than $1.3 billion in annual sales in 2023. The company expects it to eventually earn between $1.5 billion and $2 billion annually. Approved in 45 countries, Zolgensma replaces the faulty gene responsible for causing spinal muscular atrophy, a condition that in its severe form robs infants of the ability to stand, sit and, eventually, breathe. Untreated, it’s typically fatal by a very young age. Zolgensma can deliver dramatic benefits, keeping children alive and in some cases helping them achieve motor and developmental milestones they otherwise wouldn’t. In the U.S, its use is limited to babies under the age of two, where it’s seen as having the greatest benefit. About MediciNova MediciNova, Inc. is a clinical-stage biopharmaceutical company developing a broad late-stage pipeline of novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases. Based on two compounds, MN-166 (ibudilast) and MN-001 (tipelukast), with multiple mechanisms of action and strong safety profiles, MediciNova has 11 programs in clinical development. MediciNova’s lead asset, MN-166 (ibudilast), is currently in Phase 3 for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM) and is Phase 3-ready for progressive multiple sclerosis (MS). MN-166 (ibudilast) is also being evaluated in Phase 2 trials in Long COVID and substance dependence. MN 001 (tipelukast) was evaluated in a Phase 2 trial in idiopathic pulmonary fibrosis (IPF) and a second Phase 2 trial in non-alcoholic fatty liver disease (NAFLD) is ongoing. MediciNova has a strong track record of securing investigator-sponsored clinical trials funded through government grants. Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the future development and efficacy of MN-166, MN-001, MN-221, and MN-029. These forward-looking statements may be preceded by, followed by, or otherwise include the words "believes," "expects," "anticipates," "intends," "estimates," "projects," "can," "could," "may," "will," "would," “considering,” “planning” or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, risks of obtaining future partner or grant funding for development of MN-166, MN-001, MN-221, and MN-029 and risks of raising sufficient capital when needed to fund MediciNova's operations and contribution to clinical development, risks and uncertainties inherent in clinical trials, including the potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, product development and commercialization risks, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, risks associated with the reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials, and the timing of expected filings with the regulatory authorities, MediciNova's collaborations with third parties, the availability of funds to complete product development plans and MediciNova's ability to obtain third party funding for programs and raise sufficient capital when needed, and the other risks and uncertainties described in MediciNova's filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2023 and its subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements. INVESTOR CONTACT: David H. Crean, Ph.D.Chief Business OfficerMediciNova, Incinfo@medicinova.com

Phase 2Drug ApprovalPhase 3

23 Oct 2024

·www.globenewswire.com

MediciNova Announces Update of Phase 2/3 Clinical Trial of MN-166 (ibudilast) in ALS patients (COMBAT-ALS) at the 2024 Annual NEALS Meeting (Northeast Amyotrophic Lateral Sclerosis Consortium)

LA JOLLA, Calif., Oct. 23, 2024 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announced the lead Principal Investigator of this clinical trial, Björn Oskarsson, MD, FAAN presented the update of an ongoing Phase 2/3 clinical trial of MN-166 (ibudilast) in Amyotrophic Lateral Sclerosis (ALS) patients at the 2024 Annual NEALS Meeting being held virtually on Oct 21-24, 2024. The presentation entitled “COMBAT-ALS Phase 2b/3 Trial of MN-166 (Ibudilast) in ALS: Study Design and Trial Update” was given by Dr. Oskarsson during the poster session. Dr. Oskarsson discussed the background of MN-166 (ibudilast), scientific rationale, study objectives, study design, major inclusion criteria and enrollment update as of October 18, 2024. Additionally, he discussed the new NIH funding Expand Access Protocol clinical trial*1 in ALS patients. *1:https://investors.medicinova.com/news-releases/news-release-details/medicinova-support-nih-funded-expanded-access-clinical-trial About MN-166 (ibudilast) MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF). It is in late-stage clinical development for the treatment of neurodegenerative diseases such as ALS (amyotrophic lateral sclerosis), progressive MS (multiple sclerosis), and DCM (degenerative cervical myelopathy); and is also in development for glioblastoma, Long COVID, CIPN (chemotherapy-induced peripheral neuropathy), and substance use disorder. In addition, MN-166 (ibudilast) was evaluated in patients that are at risk for developing acute respiratory distress syndrome (ARDS). About MediciNova MediciNova, Inc. is a clinical-stage biopharmaceutical company developing a broad late-stage pipeline of novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases. Based on two compounds, MN-166 (ibudilast) and MN-001 (tipelukast), with multiple mechanisms of action and strong safety profiles, MediciNova has 11 programs in clinical development. MediciNova’s lead asset, MN-166 (ibudilast), is currently in Phase 3 for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM) and is Phase 3-ready for progressive multiple sclerosis (MS). MN-166 (ibudilast) is also being evaluated in Phase 2 trials in Long COVID and substance dependence. MN 001 (tipelukast) was evaluated in a Phase 2 trial in idiopathic pulmonary fibrosis (IPF) and a second Phase 2 trial in non-alcoholic fatty liver disease (NAFLD) is ongoing. MediciNova has a strong track record of securing investigator-sponsored clinical trials funded through government grants. Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the future development and efficacy of MN-166, MN-001, MN-221, and MN-029. These forward-looking statements may be preceded by, followed by, or otherwise include the words "believes," "expects," "anticipates," "intends," "estimates," "projects," "can," "could," "may," "will," "would," “considering,” “planning” or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, risks of obtaining future partner or grant funding for development of MN-166, MN-001, MN-221, and MN-029 and risks of raising sufficient capital when needed to fund MediciNova's operations and contribution to clinical development, risks and uncertainties inherent in clinical trials, including the potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, product development and commercialization risks, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, risks associated with the reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials, and the timing of expected filings with the regulatory authorities, MediciNova's collaborations with third parties, the availability of funds to complete product development plans and MediciNova's ability to obtain third party funding for programs and raise sufficient capital when needed, and the other risks and uncertainties described in MediciNova's filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2023 and its subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements. INVESTOR CONTACT: David H. Crean, Ph.D.Chief Business OfficerMediciNova, Incinfo@medicinova.com

Phase 2Phase 3Clinical Result

100 Deals associated with Tipelukast

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 2	US	MediciNova, Inc.	22 Aug 2022
Idiopathic Pulmonary Fibrosis	Phase 2	US	MediciNova, Inc.	09 Mar 2016
Hypercholesterolemia	Phase 2	US	MediciNova, Inc.	01 Mar 2016
Hypertriglyceridemia	Phase 2	US	MediciNova, Inc.	01 Mar 2016
Nonalcoholic Steatohepatitis	Phase 2	US	MediciNova, Inc.	01 Mar 2016
Asthma	Phase 2	US	MediciNova, Inc.	-
Cystitis, Interstitial	Phase 2	US	MediciNova, Inc.	-

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02681055 (CTgov)	Phase 2	Hypertriglyceridemia \| Nonalcoholic Steatohepatitis \| Hypercholesterolemia	19	MN-001	txydefqhxb(xhrjcrlmdg) = efkefialvh mececxjtaj (yqdeqrsfwp, zmcgrwakru - jpyuzcosrq) View more	-	15 Mar 2023
NCT02681055 (GlobeNewswire) Manual	Phase 2	Diabetes Mellitus, Type 2 \| Metabolic dysfunction-associated steatotic liver disease	19	MN-001 (with T2DM)	(avxygxpbub) = yiifoxpvyo qyitkvzjca (mydlcjjrcc ) View more	Positive	06 Dec 2022
				MN-001 (without T2DM)	(avxygxpbub) = lybhnliaqo qyitkvzjca (mydlcjjrcc ) View more
NCT00295854 (CTgov)	Phase 2	Cystitis, Interstitial	296	MN-001 (MN-001 500 mg qd)	zuxifwlspq(itjvrwdbmc) = wmfasgjhho rmriepokgb (ycxwhmzuny, gnnmdddqwg - nnheyqueyy) View more	-	19 Jan 2012
				MN-001 (MN-001 500 mg BID)	zuxifwlspq(itjvrwdbmc) = ossnxkfcxn rmriepokgb (ycxwhmzuny, seoxmqaifs - mpcipezolc) View more

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