ABV-1504 / ABVC BioPharma - LARVOL DELTA

A Phase I/II Study of PDC-1421 for Treating Depression in Cancer Patients (clinicaltrials.gov) - P1/2 | N=12 | Not yet recruiting | Sponsor: BioLite, Inc. | Trial completion date: Feb 2025 ➔ Feb 2027 | Trial primary completion date: Feb 2025 ➔ Feb 2027

Trial completion date • Trial primary completion date • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Oncology • Psychiatry

PDC-1421 Treatment in Adult Patients With ADHD (clinicaltrials.gov) - P2 | N=70 | Completed | Sponsor: BioLite, Inc. | Suspended ➔ Completed | Trial completion date: Jun 2024 ➔ Dec 2023 | Trial primary completion date: Jun 2024 ➔ Dec 2023

Trial completion • Trial completion date • Trial primary completion date • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

The role of adrenergic neurotransmitter reuptake inhibitors in the ADHD armamentarium. (PubMed, Expert Opin Pharmacother) - "The authors conducted a PubMed literature search using the following key words: 'ADHD' AND 'adrenergic reuptake inhibitors' OR 'nonstimulants' OR 'atomoxetine' OR 'Viloxazine' OR 'Dasotraline' OR 'Centanafadine' OR 'PDC-1421' OR 'Reboxetine' OR 'Edivoxetine' OR 'Bupropion' OR 'Venlafaxine' OR 'Duloxetine.' They reviewed FDA fact sheets of available medications for safety/tolerability studies and reviewed published clinical studies of these medications for treatment of ADHD. Adrenergic neurotransmitter reuptake inhibitors fit the diverse needs of children and adolescents with ADHD with 1) poor tolerability to stimulants (e.g. due to growth suppression, insomnia, rebound irritability, co-morbid depression, anxiety and tic disorders, substance abuse or diversion concerns), 2) cardiac risks, and/or 3) need for extended duration of action. Their differences in receptor..."

Journal • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Depression • Insomnia • Mood Disorders • Psychiatry • Sleep Disorder • Substance Abuse • Tic Disorders • Tourette Syndrome

PDC-1421 Treatment in Adult Patients With ADHD (clinicaltrials.gov) - P2 | N=99 | Suspended | Sponsor: BioLite, Inc. | Recruiting ➔ Suspended

Trial suspension • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

A Phase I/II Study of PDC-1421 for Treating Depression in Cancer Patients (clinicaltrials.gov) - P1/2 | N=12 | Not yet recruiting | Sponsor: BioLite, Inc. | Trial completion date: Mar 2024 ➔ Feb 2025 | Trial primary completion date: Mar 2024 ➔ Feb 2025

Trial completion date • Trial primary completion date • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Oncology • Psychiatry

PDC-1421 Treatment in Adult Patients With ADHD (clinicaltrials.gov) - P2 | N=99 | Recruiting | Sponsor: BioLite, Inc. | Trial completion date: Dec 2023 ➔ Jun 2024 | Trial primary completion date: Dec 2023 ➔ Jun 2024

Trial completion date • Trial primary completion date • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

ABVC BioPharma Receives US Patent Certificate of PDC-1421 for the Treatment of Major Depressive Disorder (GlobeNewswire) - "ABVC Biopharma, Inc...announced it received a US patent certificate, US 11,554,154 B2, for PDC-1421, for the treatment of Major Depressive Disorder (MDD) on April 25, 2023...The patent application was submitted to the US Patent and Trademark Office (USPTO) on July 22, 2020, under the title of 'Polygala Extract for the Treatment of Major Depressive Disorder.' The invention relates to a method for treating Major Depressive Disorder by orally administering a composition containing a Radix Polygalae (Polygala tenuifolia Willd.) extract (PDC-1421)....ABV-1504 is a botanical-based Norepinephrine Transporter (NET) inhibitor that has completed Phase II clinical studies, with plans to initiate an End of Phase II (EOP II) meeting with the FDA shortly."

Patent • CNS Disorders • Depression • Major Depressive Disorder

A Phase I/II Study of PDC-1421 for Treating Depression in Cancer Patients (clinicaltrials.gov) - P1/2 | N=12 | Not yet recruiting | Sponsor: BioLite, Inc. | Trial completion date: Mar 2023 ➔ Mar 2024 | Trial primary completion date: Mar 2023 ➔ Mar 2024

Trial completion date • Trial primary completion date • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Oncology • Psychiatry

PDC-1421 Treatment in Adult Patients With ADHD (clinicaltrials.gov) - P2 | N=99 | Recruiting | Sponsor: BioLite, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

A Phase II Study of PDC-1421 Treatment in Adult Patients With Attention-Deficit Hyperactivity Disorder (ADHD), Part II (clinicaltrials.gov) - P2; N=99; Not yet recruiting; Sponsor: BioLite, Inc.

Clinical • New P2 trial • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

A Phase I/II Study of PDC-1421 for Treating Depression in Cancer Patients (clinicaltrials.gov) - P1/2; N=12; Not yet recruiting; Sponsor: BioLite, Inc.; Trial completion date: Mar 2022 ➔ Mar 2023; Trial primary completion date: Mar 2022 ➔ Mar 2023

Clinical • Trial completion date • Trial primary completion date • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Oncology • Psychiatry

A Study of PDC-1421 Treatment in Adult Patients With Attention-Deficit Hyperactivity Disorder (ADHD) (clinicaltrials.gov) - P2; N=6; Completed; Sponsor: BioLite, Inc.; Recruiting ➔ Completed

Clinical • Trial completion • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

ABVC BioPharma Announces New PCT Filings for MDD and ADHD Treatments (Yahoo Finance) - P2, N=72; NCT02395978; Sponsor: BioLite, Inc.; "ABVC BioPharma, Inc...today announced it has filed new PCT (Patent Cooperation Treaty) applications in connection with its medicines that treat major depressive disorder (MDD) and Attention-Deficit Hyperactivity Disorder (ADHD)....A recently completed Phase II Part II clinical study for ABVC’s MDD medicine was a randomized, double-blind, placebo-controlled, multi-center trial...PDC-1421 met the pre-specified primary endpoint by demonstrating a highly significant 13.2-point reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score by Intention-To-Treat (ITT) analysis, averaged over the 6-week treatment period (overall treatment effect) from baseline, as compared to 9.2-point reduction of the placebo group."

P2 data • Patent • Attention Deficit Hyperactivity Disorder • CNS Disorders • Depression • Major Depressive Disorder

ABVC: Company Continues to Advance Lead Assets & Earlier Stage Candidates (Yahoo Finance) - "ABVC's active pipeline, two lead products - ABV-1505 and Vitargus® - are in advanced stages of development, as noted, and also importantly have the potential for multiple programs. For instance, the active ingredient in ABV-1505 (and in ABV-1504 and ABV-1601) is PDC-1421...ABVC is evaluating PDC-1421’s efficacy in treating major depressive disorder (MDD)....ABVC's clinical trial for the treatment of MDD in cancer patients studying ABV-1601 at Cedars-Sinai Medical Center (CSMC) in Los Angeles has been posted on the CSMC website. ABVC hopes to finalize the CSR by year-end 2021. ABVC also expects to form a commercial partnership in the U.S. to collaborate the development of ABV-1504 for the treatment of MDD..."

New P1/2 trial • CNS Disorders • Depression • Major Depressive Disorder

A Phase I/II Study of PDC-1421 for Treating Depression in Cancer Patients (clinicaltrials.gov) - P1/2; N=12; Not yet recruiting; Sponsor: BioLite, Inc.; Trial completion date: Dec 2022 ➔ Mar 2022; Trial primary completion date: Aug 2022 ➔ Mar 2022

Clinical • Trial completion date • Trial primary completion date • CNS Disorders • Depression • Mood Disorders • Oncology • Psychiatry

American BriVision Issues Shareholder Letter Outlining Achievements of 2020 and Outlook for 2021 (Streetinsider.com) - "ABV-1504, 1505 and 1601: In the first quarter of 2021, we will initiate an ABV-1601 Phase II Part 1 clinical trial for the treatment of major depression disorder in cancer patients at Cedars-Sinai Medical Center in Los Angeles, California. The clinical study report (CSR) should be finalized at the year-end. The CSRs of ABV-1504 Phase II for MDD, ABV-1601 Phase II for MDD for cancer patients...will enable us to have further discussions with major pharmaceutical companies about funding Phase III clinical trials and distribution."

Financing • New P2 trial • CNS Disorders • Depression

American BriVision Announces New Patent Filed for Treatment of Major Depressive Disorder (GlobeNewswire) - "American BriVision (Holding) Corporation...today announced that on July 22, 2020, it had filed with the US Patent and Trademark Office ('USPTO') a new patent for the treatment of Major Depressive Disorder....A solid dosage form of PDC-1421 can be prepared into the gelatin capsule....The company said the patent application was also filed in Taiwan and will be filed under the Patent Cooperation Treaty (PCT) within the 12-month period that has a legal effect in the contracting states of PCT....'It will serve to strengthen our global IP position for the treatment of major depressive disorder and provide product exclusivity through 2040.'"

Patent • CNS Disorders • Depression

A Study of PDC-1421 Treatment in Adult Patients With Attention-Deficit Hyperactivity Disorder (ADHD) (clinicaltrials.gov) - P2; N=6; Recruiting; Sponsor: BioLite, Inc.; Trial primary completion date: May 2020 ➔ Aug 2020

Clinical • Trial primary completion date • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders

A Study of PDC-1421 Treatment in Adult Patients With Attention-Deficit Hyperactivity Disorder (ADHD) (clinicaltrials.gov) - P2; N=105; Not yet recruiting; Sponsor: BioLite, Inc.; Initiation date: Jan 2017 ➔ Dec 2017; Trial primary completion date: Dec 2019 ➔ Jun 2019

Trial initiation date • Trial primary completion date • Attention Deficit Hyperactivity Disorder • Biosimilar • CNS Disorders

A Study of PDC-1421 Treatment in Adult Patients With Attention-Deficit Hyperactivity Disorder (ADHD) (clinicaltrials.gov) - P2; N=6; Recruiting; Sponsor: BioLite, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

A Phase I/II Study of PDC-1421 for Treating Depression in Cancer Patients (clinicaltrials.gov) - P1/2; N=12; Not yet recruiting; Sponsor: BioLite, Inc.; Trial completion date: Dec 2020 ➔ Dec 2022; Initiation date: Dec 2019 ➔ Dec 2020; Trial primary completion date: Aug 2020 ➔ Aug 2022

Clinical • Trial completion date • Trial initiation date • Trial primary completion date

American BriVision Initiates Phase II Part I Clinical Trial for ABV-1505 in Adult Attention-Deficit Hyperactivity Disorder (ADHD) (GlobeNewswire, American BriVision Holding Corporation) - "American BriVision (Holding) Corporation...today announced the initiation of a new ABV-1505 Phase II Part I clinical trial, under the U.S. Food and Drug Administration (FDA) clinical protocol code BLI-1008-001, for adult attention-deficit hyperactivity disorder (ADHD). PDC-1421, the active pharmaceutical ingredient of ABV-1505 and ABV-1504, has been successfully evaluated in a recently completed Phase II study for major depressive disorder (MDD) conducted at Stanford University and five major medical centers in Taiwan."

Clinical • Clinical data • New trial • Regulatory

A Phase II Study of PDC-1421 Capsule to Evaluate the Safety and Efficacy in Patients With Major Depressive Disorder (clinicaltrials.gov) - P2; N=60; Completed; Sponsor: BioLite, Inc.; Recruiting ➔ Completed

Clinical • Trial completion

American BriVision Announces Issuance of a Full Clinical Study Report (CSR) for ABV-1504 for Major Depressive Disorder Phase II Study (GlobeNewswire, American BriVision Holding Corporation) - "PDC-1421 high-dose data meets primary endpoint on MADRS scale in ITT clinical trial population...Company is planning for end-of-Phase II meetings with regulatory authorities to discuss path forward for Phase III pivotal trials...American BriVision (Holding) Corporation...issued a full clinical study report (CSR), under the U.S. Food and Drug Administration (FDA) and Taiwan FDA (TFDA) clinical protocol code of BLI-1005-002, for ABV-1504 major depressive disorder (MDD) Phase II study...PDC-1421 is the active pharmaceutical ingredient of ABV-1504."

Clinical • P2 data • Regulatory

A Study of PDC-1421 Treatment in Adult Patients With Attention-Deficit Hyperactivity Disorder (ADHD) (clinicaltrials.gov) - P2; N=6; Not yet recruiting; Sponsor: BioLite, Inc.; Trial completion date: Feb 2020 ➔ Jun 2020; Trial primary completion date: Nov 2019 ➔ Mar 2020

Clinical • Trial completion date • Trial primary completion date