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

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

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

BACKGROUND:

Administration 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.

OBJECTIVES:

Our goal in this study was to determine which products of arachidonate 5-lipoxygenase pathway are involved in the PIB.

METHODS:

Propranolol 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.

RESULTS:

Bronchoconstriction 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.

CONCLUSIONS:

These 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

20 Jun 2024

·www.biospace.com

MediciNova Chief Business Officer David H. Crean, Ph.D. Assumes Communications Role Overseeing Investor Engagement and Public Relations

Company to rededicate efforts toward updating stakeholders on corporate vision, strategy, and ongoing activities LA JOLLA, Calif., June 20, 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) and focused on development of novel treatments for neurodegenerative diseases, malignant brain cancers, and metabolic diseases, announces that its Chief Business Officer, David H. Crean, Ph.D., will assume management of the Company’s investor engagement, corporate communications, and public relations activities. Dr. Crean will now lead the charge to expand and enhance the Company’s communications channels, providing stakeholders with new clarity on its corporate vision and strategic approach. He is also dedicated to providing additional transparency through regular communications with shareholders on its milestones and achievements. “MediciNova’s previous approach was perhaps more conservative than is appropriate for a Company with its current market cap, and we hope to bring new people to the story through increased open engagement,” comments Crean. “We further believe that the Company has the unique opportunity to expand its outreach to stakeholders and we have reached inflection points where this is essential to the continued health and development of the Company. We have already begun to create improvements in the Company’s communications infrastructure, and we expect -- beginning with this announcement -- to engage more regularly with both current and future investors and partners.” Yuichi Iwaki, M.D., Ph.D., Medicinova’s CEO affirmed, “Medicinova’s strategy integrates a combination of active programs in neurodegeneration under the supervision of renowned scientific institutions with multiple additional programs that are being run independent of the Company’s direct investment. These will ultimately provide additional cashflow upon regulatory approvals. We believe that the complexity of the ongoing activities both from within and outside of the Company has caused a disconnect in the market. We are looking forward to ensuring a clearer message under David’s supervision, and to providing more regular outreach to both our faithful shareholders and to those who have yet to learn Medicinova’s unique story.” 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 pro MediciNova has 11 programs in clinical development, two of which are the Company’s primary focus. MediciNova’s lead asset, MN-166 (ibudilast), is currently in Phase 3 for amyotrophic lateral sclerosis (ALS), and Phase 2 in glioblastoma. 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 Officer MediciNova, Inc info@medicinova.com

Phase 2Executive Change

05 Jun 2024

·www.biospace.com

MediciNova Receives Notice of Allowance for New Patent Covering MN-166 (ibudilast) for the Prevention of Metastasis of Various Solid Cancer

LA JOLLA, Calif., June 05, 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 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. Once issued, this patent is expected to expire no earlier than July 2042. The allowed claims cover the use of MN-166 (ibudilast) in combination with one or more additional therapies including chemotherapy, immunotherapy, radiotherapy, photodynamic therapy, epigenetic therapy, and liver-directed therapy and others. The allowed claims specifically cover the use of MN-166 (ibudilast) for preventing, ameliorating, or minimizing metastasis of various cancers including pancreatic cancer, lung cancer, breast cancer, colorectal cancer, melanoma, or ovarian cancer. The allowed claims cover oral administration, a wide range of doses, a range of different dosing frequencies, and a range of different treatment periods. Kazuko Matsuda, MD, PhD, MPH, Chief Medical Officer of MediciNova, Inc., commented, “Cancer metastasis is often the major driver of cancer-related deaths rather than the primary cancer. Recently we were granted a patent *1 to cover preventing metastasis of uveal melanoma. We are delighted to see our growing intellectual property patent portfolio and value of MN-166 (ibudilast) increase with the addition of patents covering the prevention of metastasis of various solid tumors." *1: MediciNova Receives Notice of Allowance for New Patent Covering MN-166 (ibudilast) for the Prevention of Metastasis of Eye Cancer 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 pro 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 Officer MediciNova, Inc info@medicinova.com

Phase 2Phase 3

03 Jun 2024

·www.biospace.com

MediciNova Announces Data from Phase 1b/2a Clinical Trial of MN-166 (ibudilast) in Glioblastoma Patients at the American Society of Clinical Oncology (ASCO) Annual Meeting 2024

LA JOLLA, Calif., June 03, 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 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. The highlights of presentation entitled “Phase 1b/2a study evaluating the combination of MN-166 (ibudilast) and temozolomide (TMZ) in patients with newly diagnosed and recurrent glioblastoma (GBM) (Abstract # 2016)“ are as follows: The clinical study enrolled a total of 62 patients, including 36 with newly diagnosed GBM patients and 26 with recurrent GBM. The primary endpoints were safety and tolerability of MN-166 and TMZ combination treatment and the efficacy of combination treatment. The recommended Phase 2-dose (R2PD) of MN-166 is 50 mg BID. The combination of Temozolomide (TMZ) and MN-166 was safe and well tolerated. No unexpected adverse effects were observed in both new GBM and recurrent GBM patients. Most reported adverse events were Lymphopenia, Leukopenia, Thrombocytopenia and Neutropenia. Progression Free Survival at 6 months (PFS6) was 44% (new GBM) and 31% (recurrent GBM), respectively. PFS6 in recurrent GBM was higher than historical control. Median PFS was 8.7 months in new GBM and 2.4 months in recurrent GBM. Median Overall Survival (OS) was 21 months in new GBM and 8.6 months in recurrent GBM. Neither were higher than historical data. Immunohistochemistry evaluation was performed for the patients whose pre-treatment tumor tissue samples were available from resected tumors at initial surgery or biopsy to evaluate MIF (macrophage migration inhibitory factor), pERK, Ki67, CD3, CD11b, and CD74 The intra-tumoral CD3 expression was significantly higher in the patients had disease progression within 5 months of treatment initiation compared to patients that had no disease progression over 5 months, whereas the expression of MIF, CD74 (MIF receptor), Ki67 (proliferation index), and CD11b (marker expressed on myeloid-derived suppressor cells and macrophages, among other cell types) were not different between these 2 subgroups of patients. Preclinical data has shown improved survival with the combination of Ibudilast and PD-1 or PD-L1 antibody therapy compared to treatment with ibudilast alone or PD-1/PD-L1 antibody alone, suggesting a potential promising therapeutic benefit of this combination. Kazuko Matsuda, M.D., Ph.D., M.P.H., Chief Medical Officer of MediciNova, Inc., commented, “First, we wish to express our sincere thanks to the study participants, their familys, the investigators, and their staff for their dedication and courage to conduct and volunteer for this trial. We are very pleased to have the opportunity to present our positive safety and efficacy results from the clinical trial of MN-166 in the treatment of GBM at the most prestigious clinical oncology conference. GBM’s rapid progression and resistance to therapy poses a serious challenge to the medical community. Evaluation of MN-166 (ibudilast) as an adjuvant therapy with TMZ in GBM patients was generally safe and well tolerated. For the PFS6 primary efficacy endpoint, recurrent GBM patients showed a higher PFS6 rate compared to most historical studies. Moreover, the preclinical studies data from 2 different research groups presented at this meeting support our postulation that adding MN-166 (ibudilast) to existing immunotherapy, i.e. anti-PD1 or anti-PD-L1, improves survival more than the individual therapies alone. We are eager to evaluate MN-166 (ibudilast) in combination with anti-PD1 and anti-PD-L1 therapies in a future 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 pro 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 also 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 Officer MediciNova, Inc info@medicinova.com

Clinical ResultPhase 2ASCOImmunotherapy

100 Deals associated with Tipelukast

External Link

KEGG	Wiki	ATC	Drug Bank
D06659	-	-	DB12435

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Asthma	Phase 3	US	MediciNova, Inc.	-
Cystitis, Interstitial	Phase 3	US	MediciNova, Inc.	-
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

Clinical Result

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Evaluation

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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	eouubisntg(vpttokykde) = dbbnnpbjhl vlazzlutdj (uqwadbkgrj, yxyvvldxte - yooktuvjvh) 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)	dbimtbbohm(ykshvtzvjw) = fbsuoxzutg ycxgghhjff (dyboyplltf ) View more	Positive	06 Dec 2022
				MN-001 (without T2DM)	dbimtbbohm(ykshvtzvjw) = bqygokixyu ycxgghhjff (dyboyplltf ) View more
NCT00295854 (CTgov)	Phase 2	Cystitis, Interstitial	296	MN-001 (MN-001 500 mg qd)	bvgdurtrmj(abpvhgdemq) = wosvmrdghb kdpgqsqozz (igysncikcw, ucfwkjxgvj - oeppiimvlf) View more	-	19 Jan 2012
				MN-001 (MN-001 500 mg BID)	bvgdurtrmj(abpvhgdemq) = pozkasoksu kdpgqsqozz (igysncikcw, jhdruaskgo - jmhblbnrtk) View more

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