Developer · ABVC · United States
ABVC BioPharma, Inc.
Fremont, California-based biopharmaceutical company (Nasdaq: ABVC), formerly American BriVision, that develops botanical drugs for central nervous system and oncology/hematology indications, typically taking candidates through Phase II and then seeking a partner for Phase III. Its CNS candidates ABV-1504 (major depressive disorder), ABV-1505 (adult ADHD) and ABV-1601 (depression in cancer patients) all use the same active ingredient, PDC-1421, a Radix Polygalae extract developed by its majority-owned Taiwanese subsidiary BioLite, Inc. It also runs a contract development and manufacturing business through its subsidiary BioKey.
Pipeline (1)
- Major depressive disorderPhase 2Completed
- Attention-deficit/hyperactivity disorderPhase 2Completed
Deals & partnerships
- Nov 12, 2023Licensing dealABVC and BioLite license MDD and ADHD rights for PDC-1421 to AiBtl BioPharmaABVC BioPharma and its subsidiary BioLite Taiwan each entered a multi-year global licensing agreement with AiBtl BioPharma, a consolidated majority-owned ABVC subsidiary, covering clinical development, registration, manufacturing, supply and distribution of their CNS products for major depressive disorder and ADHD. Each licensor received 23 million AiBtl shares and is eligible for $3.5 million plus royalties of 5% of net sales up to $100 million. The deal followed a binding term sheet announced 2023-10-26.
Catalysts · 1 upcoming · 2 reported
- February 2028Anticipated
PDC-1421forMajor depressive disorderRegistry results
ClinicalTrials.gov estimated primary completion of the Phase I/II PDC-1421 (ABV-1601) study in depression in cancer patients: February 2028
Recently reported
- 2026-05-06missed
PDC-1421forAttention-deficit/hyperactivity disorderRegistry results
Phase 2 Part II of PDC-1421 (ABV-1505) in adult ADHD: posted results show no responder advantage over placebo (placebo 50%, low dose 39%, high dose 42%)
- 2019-05-23mixed
PDC-1421forMajor depressive disorderFull results
Phase 2 PDC-1421 (ABV-1504) in MDD: sponsor reports the high dose met its primary endpoint (MADRS -13.2 vs -9.2 placebo, ITT); the registry-posted Week-6 primary analysis is p=0.393
Recent activity
- May 6, 2026ReadoutPDC-1421·Attention-deficit/hyperactivity disordermissedPhase 2 Part II of PDC-1421 (ABV-1505) in adult ADHD: posted results show no responder advantage over placebo (placebo 50%, low dose 39%, high dose 42%)source ↗
- Apr 8, 2024Phase changePDC-1421·Attention-deficit/hyperactivity disorderPhase 2Part II completed (CT.gov study completion date; primary completion 2023-12-06). Results posted 2026-05-06 show no separation from placebo on the primary responder endpoint.source ↗
- Apr 7, 2022Phase changePDC-1421·Attention-deficit/hyperactivity disorderPhase 2Randomized, double-blind, placebo-controlled Part II (NCT05202327) started at UCSF and five Taiwanese sites.source ↗
- Jul 15, 2020Phase changePDC-1421·Attention-deficit/hyperactivity disorderPhase 2Part I last patient visit; full clinical study report issued 2020-10-24, which the sponsor described as showing safety, tolerability and efficacy.source ↗
- Dec 1, 2019Phase changePDC-1421·Attention-deficit/hyperactivity disorderPhase 2Open-label Phase 2 Part I in adult ADHD (NCT02699086, UCSF) started.source ↗
- May 23, 2019ReadoutPDC-1421·Major depressive disordermixedPhase 2 PDC-1421 (ABV-1504) in MDD: sponsor reports the high dose met its primary endpoint (MADRS -13.2 vs -9.2 placebo, ITT); the registry-posted Week-6 primary analysis is p=0.393source ↗
- Mar 18, 2019Phase changePDC-1421·Major depressive disorderPhase 2Phase 2 MDD study completed (CT.gov study completion date). The sponsor announced results on 2019-05-23, claiming the high dose met its primary endpoint; the registry-posted primary analysis is p=0.393. The 10-Q gives 2019-10-31 as the Phase II completion date.source ↗
- Apr 10, 2015Phase changePDC-1421·Major depressive disorderPhase 2Phase 2 MDD study NCT02395978 (BLI-1005-002) started, after US FDA Phase 2 IND clearance in March 2014 and Taiwan FDA clearance in June 2014.source ↗
- Nov 13, 2012Phase changePDC-1421·Major depressive disorderPhase 1First subject visit in the Phase 1 single-dose escalation study in healthy volunteers at Taipei Veterans General Hospital (NCT01774045); 30 enrolled, last visit 2013-07-05.source ↗
Competitive landscape
Other companies developing against ABVC BioPharma, Inc.'s targets or indications.
- Axsome Therapeutics, Inc.3 compoundsNETMajor depressive disorderAttention-deficit/hyperactivity disorder
- Otsuka Pharmaceutical Co., Ltd.3 compoundsNETMajor depressive disorderAttention-deficit/hyperactivity disorder
- Definium Therapeutics, Inc.1 compoundMajor depressive disorderAttention-deficit/hyperactivity disorder
- Theravance Biopharma, Inc.1 compoundNETAttention-deficit/hyperactivity disorder
- Alto Neuroscience, Inc.2 compoundsMajor depressive disorder
- Autobahn Therapeutics, Inc.1 compoundMajor depressive disorder
- Beckley Psytech Limited1 compoundMajor depressive disorder
- Biohaven Ltd.1 compoundMajor depressive disorder
- Boehringer Ingelheim2 compoundsMajor depressive disorder
- Cerevel Therapeutics1 compoundMajor depressive disorder
- COMPASS Pathways plc1 compoundMajor depressive disorder
- CSPC ZhongQi Pharmaceutical Technology (Shijiazhuang) Co., Ltd.1 compoundMajor depressive disorder