Last update 21 Nov 2024
PKP2-gene therapy (Tenaya Therapeutics)
Last update 21 Nov 2024
Overview
Basic Info
Drug Type AAV based gene therapy |
Synonyms- |
Target- |
Mechanism Gene transference |
Therapeutic Areas |
Active Indication- |
Inactive Indication |
Originator Organization |
Active Organization- |
Inactive Organization |
Drug Highest PhaseDiscontinuedPreclinical |
First Approval Date- |
Regulation- |
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4
News (Medical) associated with PKP2-gene therapy (Tenaya Therapeutics)31 Aug 2023
SOUTH SAN FRANCISCO, Calif., Aug. 31, 2023 (GLOBE NEWSWIRE) -- Tenaya Therapeutics Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today announced that Faraz Ali, Chief Executive Officer, will participate in the 21st Annual Morgan Stanley Global Healthcare Conference taking place in New York City. Details of participation are as follows:
Fireside Chat
Date: September 12, 2023
Time: 11:55 AM PT / 2:55 PM ET
A webcast of the event will be available for approximately 90 days by visiting the Investors section of Tenaya’s website. An updated version of Tenaya’s corporate presentation is also available on the company’s website.
About Tenaya Therapeutics
Tenaya Therapeutics is a clinical-stage biotechnology company committed to a bold mission: to discover, develop and deliver potentially curative therapies that address the underlying drivers of heart disease. Leveraging its integrated and interrelated Gene Therapy, Cellular Regeneration and Precision Medicine platforms and proprietary core capabilities, the company is advancing a pipeline of novel therapies with diverse treatment modalities for rare genetic cardiovascular disorders and more prevalent heart conditions. Tenaya’s most advanced candidates include TN-201, a gene therapy for MYBPC3-associated hypertrophic cardiomyopathy (HCM), TN-401, a gene therapy for PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC), and TN-301, a small molecule HDAC6 inhibitor being initially developed for heart failure with preserved ejection fraction (HFpEF). Tenaya also has multiple early-stage programs progressing through preclinical development. For more information, visit .
Contacts
Investors
Michelle Corral
Vice President, Investor Relations and Corporate Communications
Tenaya Therapeutics
IR@tenayathera.com
Media
Wendy Ryan
Ten Bridge Communications
wendy@tenbridgecommunications.com
Gene Therapy
09 Aug 2023
Dosing of First Patient in Phase 1b Trial of TN-201 On Track to Occur in Q3 2023
Data from Phase 1 Clinical Trial of TN-301 Accepted for Presentation at HFSA 2023
IND Application for TN-401 Anticipated in Second Half 2023
Second Quarter Cash and Investments of $152 Million; Runway to Fund Operations into First Half 2025
SOUTH SAN FRANCISCO, Calif., Aug. 09, 2023 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today reported financial results and provided a corporate update for the second quarter ended June 30, 2023.
“We are looking ahead to important near-term milestones across all our programs. Dosing the first patient in our first clinical trial for TN-201 will be a significant moment for our company and bring us one step closer to bringing much-needed solutions to those impacted by genetic HCM,” said Faraz Ali, Chief Executive Officer of Tenaya. “We are also looking forward to presenting healthy participant data from our TN-301 small molecule program and filing the IND for our TN-401 gene therapy candidate later this year. Our continued progress is supported by our unwavering commitment to fight heart disease on behalf of individuals and families.”
Business and Program Updates
TN-201 – Gene Therapy for MYBPC3-Associated Hypertrophic Cardiomyopathy (HCM)
In April 2023, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for Tenaya’s lead gene therapy program, TN-201. Companies with therapies that receive the Fast Track designation are eligible for more frequent communication with the agency and may qualify for Accelerated Approval and Priority Review if relevant criteria are met.
Tenaya anticipates dosing its first patient in the “MyPeak-1” Phase 1b multi-center, open-label, dose-escalation clinical trial of TN-201 during the third quarter of 2023 (ClinicalTrials.gov #NCT05836259).
The Phase 1b trial is designed to assess the safety, tolerability and pharmacodynamics of a one-time intravenous infusion of TN-201 in symptomatic adults with MYBPC3-associated HCM. Initial data from the MyPeak-1 clinical trial are anticipated in 2024.
In July 2023, Tenaya received notification from the U.S. Patent and Trademarks Office (USPTO) that a notice of allowance has been issued for patent application No. 17/581,576. The allowed patent application includes claims covering a method of treating HCM or cardiomyopathy caused by a MYBPC3 mutation and expands upon Tenaya’s existing composition of matter protections by extending coverage to methods of use as the company continues to enhance its protection around different aspects of the TN-201 gene therapy program. The new patent issuing from the allowed patent application is expected to expire no earlier than February 2041.
TN-301 – Small Molecule HDAC6 Inhibitor for Heart Failure with Preserved Ejection Fraction (HFpEF)
Data from Tenaya’s Phase 1 clinical trial of TN-301 in healthy volunteers have been accepted for presentation at the Heart Failure Society of America’s (HFSA) Annual Scientific Meeting, taking place October 6-9, 2023.
Tenaya has completed the Phase 1 clinical trial of TN-301 in healthy participants. No dose-limiting toxicities were reported across a wide range of doses and initial target engagement, measured by the biomarker tubulin acetylation, was achieved.
The randomized, double-blind, placebo-controlled clinical trial was designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating oral doses of TN-301 to help guide dosing in future studies.
Results from preclinical studies testing the combination of HDAC6 inhibition with SGLT2 inhibition in a validated model of HFpEF have also been accepted for presentation at the upcoming HFSA meeting.
Preclinical data from the TN-301 program presented on August 1, 2023, at the American Heart Association’s Basic Cardiovascular Sciences (BCVS) Scientific Session suggest HDAC6 inhibition may improve undesirable HFpEF phenotype characteristics such as dysregulated metabolism, fibrosis and hypertrophy.
TN-401 – Gene Therapy for PKP2-Associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)
Tenaya plans to submit an Investigational New Drug application (IND) to the FDA for TN-401 for the potential treatment of ARVC caused by PKP2 genetic mutations in the second half of 2023. A single dose of TN-401 is designed to deliver a fully functional PKP2 gene to cardiomyocytes in the heart and restore production of the plakophilin 2 protein in order to prevent arrhythmia and reverse disease following a single dose.
Tenaya presented data from a new preclinical mouse model at BCVS on August 1, 2023, showing that a single dose of gene therapy prevented ARVC development and significantly prolonged survival.
In June 2023, Tenaya received notification from the USPTO that a notice of allowance has been issued for patent application No. 17/390,395. The new patent issuing from the allowed patent application will be the first patent issued by the USPTO to cover an AAV gene therapy for PKP2 and is expected to expire no earlier than July 2041.
Research
Tenaya researchers also presented new data at BCVS on August 1, 2023, detailing the company’s drug discovery capabilities for identifying human genetic targets in models of human heart conditions. Tenaya’s novel high throughput screening methods in human induced pluripotent stem cells derived cardiomyocytes were applied to identifying genes of interest in heart muscle cells.
Second Quarter 2023 Financial Highlights
Cash Position and guidance: As of June 30, 2023, cash, cash equivalents and investments in marketable securities were $151.6 million. Tenaya expects current cash, cash equivalents and investments in marketable securities (current and noncurrent) will be sufficient to fund the company into the first half of 2025.
Research & Development (R&D) Expenses: R&D expenses for the quarter ended June 30, 2023, were $26.5 million. Non-cash stock-based compensation included in R&D expense was $1.8 million for the quarter ended June 30, 2023.
General & Administrative (G&A) Expenses: G&A expenses for the quarter ended June 30, 2023, were $8.6 million. Non-cash stock-based compensation included in G&A expense was $2.1 million for the quarter ended June 30, 2023.
Net Loss: Net loss for the quarter ended June 30, 2023, was $33.3 million, or $0.45 per share.
About Tenaya Therapeutics
Tenaya Therapeutics is a clinical-stage biotechnology company committed to a bold mission: to discover, develop and deliver potentially curative therapies that address the underlying drivers of heart disease. Leveraging its integrated and interrelated Gene Therapy, Cellular Regeneration and Precision Medicine platforms and proprietary core capabilities, the company is advancing a pipeline of novel therapies with diverse treatment modalities for rare genetic cardiovascular disorders and more prevalent heart conditions. Tenaya’s most advanced candidates include TN-201, a gene therapy for MYBPC3-associated hypertrophic cardiomyopathy (HCM), TN-401, a gene therapy for PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC), and TN-301, a small molecule HDAC6 inhibitor being initially developed for heart failure with preserved ejection fraction (HFpEF). Tenaya also has multiple early-stage programs progressing through preclinical development. For more information, visit .
Forward-looking Statement
This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Words such as “anticipated,” “looking ahead,” “looking forward,” “may,” “expected,” “plans,” “will,” and similar expressions are intended to identify forward-looking statements. Such forward-looking statements include, among other things, statements regarding 2023 development and regulatory milestones; Tenaya’s plan to present data from the Phase 1 clinical trial evaluating TN-301, as well as results from preclinical studies, at the upcoming HFSA conference; expected timing of the submission of the TN-401 IND; eligibility for increased communication with the FDA and potential qualification for accelerated approval and priority review for TN-201; expected timing for, commencement of dosing in the Phase 1b clinical trial evaluating TN-201 and availability of initial data from the trial; the expected expiration dates of new patents; the potential for Tenaya’s future programs; the sufficiency of Tenaya’s cash resources to fund the company into the first half 2025; and statements by Tenaya’s chief executive officer. The forward-looking statements contained herein are based upon Tenaya’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. These forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, including but not limited to: Tenaya’s ability to develop, initiate or complete preclinical studies and clinical trials for its product candidates; the timing, scope and likelihood of regulatory filings and approvals; the availability of data at the referenced times; risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early stage company; Tenaya’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; the potential for any clinical trial results to differ from preclinical, interim, preliminary, topline or expected results; Tenaya’s ability to successfully operate a manufacturing facility for clinical or commercial supply; Tenaya’s commercialization and marketing capabilities and strategy; the loss of key scientific or management personnel; competition in the industry in which Tenaya operates; Tenaya’s reliance on third parties; Tenaya’s ability to obtain and maintain intellectual property protection for its product candidates; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in documents that Tenaya files from time to time with the Securities and Exchange Commission. These forward-looking statements are made as of the date of this press release, and Tenaya assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Contacts
Investors
Media
Michelle Corral
Wendy Ryan
Vice President, Investor Relationship and
Ten Bridge Communications
Corporate Communications
Wendy@tenbridgecommunications.com
Tenaya Therapeutics
IR@tenayathera.com
TENAYA THERAPEUTICS, INC.
Condensed Statements of Operations
(In thousands, except share and per share data)
(Unaudited)
Three Months Ended
June 30,
Six Months Ended
June 30,
2023
2022
2023
2022
Operating expenses:
Research and development
$
26,477
$
20,876
$
52,082
$
45,031
General and administrative
8,627
7,743
16,745
14,742
Total operating expenses
35,104
28,619
68,827
59,773
Loss from operations
(35,104
)
(28,619
)
(68,827
)
(59,773
)
Other income (expense), net:
Interest income
1,837
222
3,810
321
Other income (expense), net
(2
)
—
11
(1
)
Total other income (expense), net
1,835
222
3,821
320
Net loss before income tax expense
(33,269
)
(28,397
)
(65,006
)
(59,453
)
Income tax expense
—
—
—
—
Net loss
$
(33,269
)
$
(28,397
)
$
(65,006
)
$
(59,453
)
Net loss per share, basic and diluted
$
(0.45
)
$
(0.69
)
$
(0.89
)
$
(1.44
)
Weighted-average shares used in computing net loss per share, basic and diluted
73,399,847
41,302,157
73,249,702
41,285,168
Condensed Balance Sheet Data
(In thousands)
(Unaudited)
June 30,
December 31,
2023
2022
Cash, cash equivalents and marketable securities
$
151,641
$
204,230
Total assets
$
220,754
$
278,945
Total liabilities
$
30,814
$
35,569
Total liabilities and stockholders’ equity
$
220,754
$
278,945
Phase 1Gene TherapyFinancial StatementFast Track
03 May 2023
Akosua Mireku
@AkosuaMireku1
Close-up photo of a stressed man who is suffering from a chest pain and touching his heart area. Hypertrophic cardiomyopathy is a condition affecting the heart. Credit: damircudic via Getty Images
The US Food and Drug Administration (FDA) has granted Tenaya Therapeutics’ gene therapy TN-201 a fast track designation for the treatment of myosin binding protein C3 (MYBPC3)-associated hypertrophic cardiomyopathy (HCM). If successful, TN-201 would be a first-in-class disease-modifying gene therapy for MYBPC3-associated HCM.
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In January 2023, Tenaya announced FDA clearance for its Investigational New Drug (IND) application for TN-201. With this recent news, San Francisco-based Tenaya is initiating a multi-centre, open-label Phase Ib clinical trial for the drug. The company predicts that the first patient will be dosed in the MyPeak-1 trial in the third quarter of 2023. Tenaya is also running two supplementary non-interventional studies for the drug. One study is looking at the seroprevalence of AAV9 antibodies among adults with MYBPC3-associated HCM, and the other, MyClimb, is a natural history study of pediatric patients with MYBPC3-associated HCM.
TN-201 is an intravenously delivered
adeno-associated virus (AAV)-
based
investigational gene therapy
that works by correcting mutations in the MYBPC3 gene, the most common cause of HCM. Mutations in this gene cause a decrease in the maximal force of cardiac contractions. Tenaya’s treatment delivers a functional MYPC3 gene, restoring myosin-binding protein levels to normal. TN-201 is one of four AAV-based gene therapies in Tenaya’s pipeline.
In April 2022,
Bristol Myers Squibb’s
Camzyos (mavacamten) became the
first FDA-approved cardiac myosin inhibitor
to treat obstructive HCM. Results from a Phase III trial where
Cytokinetics
is studying its investigational cardiac myosin inhibitor aficamten are expected in December.
HCM is the most common inherited cardiac disorder. In the US, MYBPC3-associated HCM accounts for approximately 20% of all HCM cases, affecting approximately 115,000 patients. According to the Mayo Clinic, HCM refers to “a disease in which the heart muscle becomes thickened (hypertrophied)”. Many people with HCM are asymptomatic. HCM can lead to other complications such as atrial fibrillation, blood clots, and strokes.
In a May 2 press release
, Tenaya’s CMO Dr. Whit Tingley said, “Receipt of fast track designation for TN-201 reflects the pressing unmet need among HCM patients whose disease is caused by MYBPC3 genetic mutations”.
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GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects.
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Bolivia (+591)
Bosnia Herzegovina (+387)
Botswana (+267)
Brazil (+55)
Brunei (+673)
Bulgaria (+359)
Burkina Faso (+226)
Burundi (+257)
Cambodia (+855)
Cameroon (+237)
Canada (+1)
Cape Verde Islands (+238)
Cayman Islands (+1345)
Central African Republic (+236)
Chile (+56)
China (+86)
Colombia (+57)
Comoros (+269)
Congo (+242)
Cook Islands (+682)
Costa Rica (+506)
Croatia (+385)
Cuba (+53)
Cyprus North (+90392)
Cyprus South (+357)
Czech Republic (+42)
Denmark (+45)
Djibouti (+253)
Dominica (+1809)
Dominican Republic (+1809)
Ecuador (+593)
Egypt (+20)
El Salvador (+503)
Equatorial Guinea (+240)
Eritrea (+291)
Estonia (+372)
Ethiopia (+251)
Falkland Islands (+500)
Faroe Islands (+298)
Fiji (+679)
Finland (+358)
France (+33)
French Guiana (+594)
French Polynesia (+689)
Gabon (+241)
Gambia (+220)
Georgia (+7880)
Germany (+49)
Ghana (+233)
Gibraltar (+350)
Greece (+30)
Greenland (+299)
Grenada (+1473)
Guadeloupe (+590)
Guam (+671)
Guatemala (+502)
Guinea (+224)
Guinea - Bissau (+245)
Guyana (+592)
Haiti (+509)
Honduras (+504)
Hong Kong (+852)
Hungary (+36)
Iceland (+354)
India (+91)
Indonesia (+62)
Iran (+98)
Iraq (+964)
Ireland (+353)
Israel (+972)
Italy (+39)
Jamaica (+1876)
Japan (+81)
Jordan (+962)
Kazakhstan (+7)
Kenya (+254)
Kiribati (+686)
Korea North (+850)
Korea South (+82)
Kuwait (+965)
Kyrgyzstan (+996)
Laos (+856)
Latvia (+371)
Lebanon (+961)
Lesotho (+266)
Liberia (+231)
Libya (+218)
Liechtenstein (+417)
Lithuania (+370)
Luxembourg (+352)
Macao (+853)
Macedonia (+389)
Madagascar (+261)
Malawi (+265)
Malaysia (+60)
Maldives (+960)
Mali (+223)
Malta (+356)
Marshall Islands (+692)
Martinique (+596)
Mauritania (+222)
Mayotte (+269)
Mexico (+52)
Micronesia (+691)
Moldova (+373)
Monaco (+377)
Mongolia (+976)
Montserrat (+1664)
Morocco (+212)
Mozambique (+258)
Myanmar (+95)
Namibia (+264)
Nauru (+674)
Nepal (+977)
Netherlands (+31)
New Caledonia (+687)
New Zealand (+64)
Nicaragua (+505)
Niger (+227)
Nigeria (+234)
Niue (+683)
Norfolk Islands (+672)
Northern Marianas (+670)
Norway (+47)
Oman (+968)
Palau (+680)
Panama (+507)
Papua New Guinea (+675)
Paraguay (+595)
Peru (+51)
Philippines (+63)
Poland (+48)
Portugal (+351)
Puerto Rico (+1787)
Qatar (+974)
Reunion (+262)
Romania (+40)
Russia (+7)
Rwanda (+250)
San Marino (+378)
Sao Tome & Principe (+239)
Saudi Arabia (+966)
Senegal (+221)
Serbia (+381)
Seychelles (+248)
Sierra Leone (+232)
Singapore (+65)
Slovak Republic (+421)
Slovenia (+386)
Solomon Islands (+677)
Somalia (+252)
South Africa (+27)
Spain (+34)
Sri Lanka (+94)
St. Helena (+290)
St. Kitts (+1869)
St. Lucia (+1758)
Sudan (+249)
Suriname (+597)
Swaziland (+268)
Sweden (+46)
Switzerland (+41)
Syria (+963)
Taiwan (+886)
Tajikstan (+7)
Thailand (+66)
Togo (+228)
Tonga (+676)
Trinidad & Tobago (+1868)
Tunisia (+216)
Turkey (+90)
Turkmenistan (+7)
Turkmenistan (+993)
Turks & Caicos Islands (+1649)
Tuvalu (+688)
Uganda (+256)
Ukraine (+380)
United Arab Emirates (+971)
Uruguay (+598)
Uzbekistan (+7)
Vanuatu (+678)
Vatican City (+379)
Venezuela (+58)
Vietnam (+84)
Virgin Islands - British (+1284)
Virgin Islands - US (+1340)
Wallis & Futuna (+681)
Yemen (North)(+969)
Yemen (South)(+967)
Zambia (+260)
Zimbabwe (+263)
Country
UK
USA
Afghanistan
Åland Islands
Albania
Algeria
American Samoa
Andorra
Angola
Anguilla
Antarctica
Antigua and Barbuda
Argentina
Armenia
Aruba
Australia
Austria
Azerbaijan
Bahamas
Bahrain
Bangladesh
Barbados
Belarus
Belgium
Belize
Benin
Bermuda
Bhutan
Bolivia
Bonaire, Sint Eustatius and Saba
Bosnia and Herzegovina
Botswana
Bouvet Island
Brazil
British Indian Ocean Territory
Brunei Darussalam
Bulgaria
Burkina Faso
Burundi
Cambodia
Cameroon
Canada
Cape Verde
Cayman Islands
Central African Republic
Chad
Chile
China
Christmas Island
Cocos Islands
Colombia
Comoros
Congo
Democratic Republic of
the Congo
Cook Islands
Costa Rica
Côte d"Ivoire
Croatia
Cuba
Curaçao
Cyprus
Czech Republic
Denmark
Djibouti
Dominica
Dominican Republic
Ecuador
Egypt
El Salvador
Equatorial Guinea
Eritrea
Estonia
Ethiopia
Falkland Islands
Faroe Islands
Fiji
Finland
France
French Guiana
French Polynesia
French Southern Territories
Gabon
Gambia
Georgia
Germany
Ghana
Gibraltar
Greece
Greenland
Grenada
Guadeloupe
Guam
Guatemala
Guernsey
Guinea
Guinea-Bissau
Guyana
Haiti
Heard Island and McDonald Islands
Holy See
Honduras
Hong Kong
Hungary
Iceland
India
Indonesia
Iran
Iraq
Ireland
Isle of Man
Israel
Italy
Jamaica
Japan
Jersey
Jordan
Kazakhstan
Kenya
Kiribati
North Korea
South Korea
Kuwait
Kyrgyzstan
Lao
Latvia
Lebanon
Lesotho
Liberia
Libyan Arab Jamahiriya
Liechtenstein
Lithuania
Luxembourg
Macao
Macedonia, The Former
Yugoslav Republic of
Madagascar
Malawi
Malaysia
Maldives
Mali
Malta
Marshall Islands
Martinique
Mauritania
Mauritius
Mayotte
Mexico
Micronesia
Moldova
Monaco
Mongolia
Montenegro
Montserrat
Morocco
Mozambique
Myanmar
Namibia
Nauru
Nepal
Netherlands
New Caledonia
New Zealand
Nicaragua
Niger
Nigeria
Niue
Norfolk Island
Northern Mariana Islands
Norway
Oman
Pakistan
Palau
Palestinian Territory
Panama
Papua New Guinea
Paraguay
Peru
Philippines
Pitcairn
Poland
Portugal
Puerto Rico
Qatar
Réunion
Romania
Russian Federation
Rwanda
Saint Helena, Ascension and Tristan da Cunha
Saint Kitts and Nevis
Saint Lucia
Saint Pierre and Miquelon
Saint Vincent and The Grenadines
Samoa
San Marino
Sao Tome and Principe
Saudi Arabia
Senegal
Serbia
Seychelles
Sierra Leone
Singapore
Slovakia
Slovenia
Solomon Islands
Somalia
South Africa
South Georgia and The South
Sandwich Islands
Spain
Sri Lanka
Sudan
Suriname
Svalbard and Jan Mayen
Swaziland
Sweden
Switzerland
Syrian Arab Republic
Taiwan
Tajikistan
Tanzania
Thailand
Timor-Leste
Togo
Tokelau
Tonga
Trinidad and Tobago
Tunisia
Turkey
Turkmenistan
Turks and Caicos Islands
Tuvalu
Uganda
Ukraine
United Arab Emirates
US Minor Outlying Islands
Uruguay
Uzbekistan
Vanuatu
Venezuela
Vietnam
British Virgin Islands
US Virgin Islands
Wallis and Futuna
Western Sahara
Yemen
Zambia
Zimbabwe
Kosovo
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Phase 3Fast TrackGene TherapyDrug ApprovalPhase 2
100 Deals associated with PKP2-gene therapy (Tenaya Therapeutics)
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R&D Status
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Cardiovascular Diseases | Preclinical | US | - |
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