KAINOS MEDICINE, INC.
License-out focused drug developer behind the Parkinson's disease candidate KM-819 and the HIV therapy KM-023.
As of 2026-10-08, KAINOS MEDICINE, INC. has 13 PubMed-indexed papers on record (counted by the MAA Company Index from its own matching of public databases).
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Business overview
Source: DART corporate disclosureFounded in 2017 and listed on KOSDAQ in 2018, the company develops new drug candidates on a license-out business model. Its pipeline includes the Parkinson's disease drug KM-819, a multiple system atrophy (MSA) candidate, the HIV therapy KM-023, and the anticancer candidates IRAK4 and FAF1-novel delivery. KM-819 received FDA Phase 2 IND approval in the US, and its MSA indication received Korea Phase 2 IND approval from the MFDS in October 2025; KM-023, licensed to Chinese partner Jiangsu Aidea Pharm., saw ACC007 gain Chinese NDA approval in 2021 and ACC008 in 2023.
Products & technology
- ACC007 (Ainuovirine)HIV therapy
- ACC008 (Ainuomiti)HIV therapy, single-tablet combination (ACC007+TDF+3TC)
Clinical trials
data.go.kr4 MFDS clinical trial authorisations · 2015–2025 (Phase 2 2 · Phase 1 2)
- Phase 2KM-819정2025-10-20
2 trial sites
- Phase 2KM-819정2021-10-22
2 trial sites
- Phase 1KM-819정2016-10-21
1 trial site
- Phase 1KM-819정2015-12-29
1 trial site
Global clinical trials
ClinicalTrials.gov · sponsor-matchedPhase 2 · Terminated · 2023-02 · NCT05695378
- Subsidiary: FAScinate Therapeutics Inc.A Study to Evaluate Safety and Efficacy of KM-819 in Healthy Adults and Participants with Parkinson's Disease
Phase 2 · Unknown · 2022-07 · NCT05670782
Phase 1 · Completed · 2016-11 · NCT03022799
- Single Ascending Dose (SAD)/Multiple Ascending Dose(MAD) Safety/Pharmacokinetic (PK) Study of KM-023
Phase 1 · Completed · 2011-05 · NCT01348516
R&D and key agreements
Source: DART corporate disclosureKM-819 · 파킨슨병 · 미국 FDA 임상2상 IND 승인, Part1a/1b 완료 · Developed via US subsidiary FAScinate; Phase 2 IND approved by FDA, Part 1a/1b completed, addressing FDA comments to proceed to Part 2
KM-819 (MSA 적응증) · 다계통위축증(MSA) · 한국 임상2상 IND 승인(2025.10) · Same compound as KM-819 for MSA; Korea Phase 2 IND approved by MFDS in Oct 2025; US clinical site expansion under discussion
KM-023 · 에이즈(HIV) · 기술이전 완료, 상업화 단계(파트너사) · Licensed to Jiangsu Aidea Pharm. for China (incl. Taiwan, Hong Kong) in 2014; global rights (ex-Korea) licensed in April 2023
IRAK4 · 혈액암(백혈병, 림프종) · 공동연구개발 및 기술이전 완료, 파트너사 후속연구 중단 · Co-development and license agreement with US-based Emmaus in 2021; Emmaus holds US/EU/UK commercial rights but follow-up research is paused due to its financial situation; company retains rights elsewhere
FAF1-novel delivery · 항암(적응증 미정) · 초기 후보물질 창출 연구단계 · Early hit-to-lead research completed; platform development and preclinical candidate selection ongoing
Key disclosures
KRX KIND via OpenDARTShow 23 more events
Publications
PubMed · affiliation-matched- Risk of drug-induced liver injury in multiple system atrophy patients treated with KM-819 is potentially associated with the HLA-DPB1*05:01:01:01 allele.
The pharmacogenomics journal · 2026-09 · Han JH, Andrade RJ, Björnsson ES 외 9
- 3C3 alleviates atopic dermatitis-like phenotypes through cyclophilin A and B-mediated inhibition of calcineurin-NFAT pathway.
International immunopharmacology · 2025-10 · Jo Y, Jeong H, Lee SJ 외 10
- Rat Pharmacokinetics and In Vitro Metabolite Identification of KM-819, a Parkinson's Disease Candidate, Using LC-MS/MS and LC-HRMS.
Molecules (Basel, Switzerland) · 2024-02 · Choi HI, Kim T, Kim JW 외 5
- Pharmacological Intervention Targeting FAF1 Restores Autophagic Flux for α-Synuclein Degradation in the Brain of a Parkinson's Disease Mouse Model.
ACS chemical neuroscience · 2022-03 · Kim BS, Song JA, Jang KH 외 5
- Effects of losartan and l-serine in a mouse liver fibrosis model.
Life sciences · 2021-08 · Yun HH, Park S, Chung MJ 외 12
- Fas-associated factor 1 induces the accumulation of α-synuclein through autophagic suppression in dopaminergic neurons.
FASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2021-04 · Kim BS, Jang T, Yoo SE 외 2
- Neurorestorative Effects of a Novel Fas-Associated Factor 1 Inhibitor in the MPTP Model: An [18F]FE-PE2I Positron Emission Tomography Analysis Study.
Frontiers in pharmacology · 2020-01 · Park HS, Song YS, Moon BS 외 6
- A novel chalcone derivative as Nrf2 activator attenuates learning and memory impairment in a scopolamine-induced mouse model.
European journal of medicinal chemistry · 2020-01 · Kim HJ, Jang BK, Park JH 외 7
- 1H-NMR-Based Metabolic Profiling of Cordyceps militaris to Correlate the Development Process and Anti-Cancer Effect.
Journal of microbiology and biotechnology · 2019-08 · Oh J, Choi E, Yoon DH 외 4
- A first-in-human study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of KM-819 (FAS-associated factor 1 inhibitor), a drug for Parkinson's disease, in healthy volunteers.
Drug design, development and therapy · 2019-01 · Shin W, Lim KS, Kim MK 외 8
Show 3 more publications
- Synthesis of 1'-C-cyano pyrimidine nucleosides and characterization as HCV polymerase inhibitors.
Nucleosides, nucleotides & nucleic acids · 2015-01 · Kirschberg TA, Mish M, Squires NH 외 8
- Novel, sulfonamide linked inhibitors of the hepatitis C virus NS3 protease.
Bioorganic & medicinal chemistry letters · 2014-02 · Kirschberg TA, Squires NH, Yang H 외 5
- Pharmacokinetics and tolerability of the new second-generation nonnucleoside reverse- transcriptase inhibitor KM-023 in healthy subjects.
Drug design, development and therapy · 2014-01 · Cha YJ, Lim KS, Park MK 외 7
Patents
KIPRIS · applicant-matchedTW · Published · 2025-07 · Application 114128746
PCT · Published · 2025-07 · Application PCT/KR2025/010731
Published · 2025-07 · Application 1020250098308
TW · Registered · 2023-09 · Application 112137391
TW · Registered · 2023-09 · Application 112137390
EP · Published · 2023-09 · Application 23873039.4
CN · Published · 2023-09 · Application 202380069117.2
PCT · Published · 2023-09 · Application PCT/KR2023/014698
PCT · Published · 2023-09 · Application PCT/KR2023/014695
Published · 2023-09 · Application 1020230128005
Show 55 more patents
Published · 2022-09 · Application 1020220124120
EP · Published · 2022-04 · Application 22904855.8
US · Published · 2022-04 · Application 18717260
PCT · Published · 2022-04 · Application PCT/US2022/023632
EP · Published · 2022-03 · Application 22781592.5
US · Published · 2022-03 · Application 18283108
PCT · Published · 2022-03 · Application PCT/KR2022/004475
Published · 2022-03 · Application 1020220039307
PCT · Published · 2021-06 · Application PCT/KR2021/006886
EP · Published · 2020-09 · Application 20871006.1
US · Registered · 2020-09 · Application 17764668
PCT · Published · 2020-09 · Application PCT/KR2020/013397
Registered · 2020-09 · Application 1020227014342
PCT · Published · 2020-08 · Application PCT/KR2020/011268
EP · Published · 2019-01 · Application 19748229.2
CN · Published · 2019-01 · Application 201980010754.6
Withdrawn · 2019-01 · Application 1020207023962
US · Registered · 2019-01 · Application 16965544
PCT · Published · 2019-01 · Application PCT/US2019/015890
Registered · 2019-01 · Application 1020247032981
EP · Published · 2018-06 · Application 18820452.3
CN · Published · 2018-06 · Application 201880040954.1
US · Registered · 2018-06 · Application 16622138
PCT · Published · 2018-06 · Application PCT/IB2018/000766
JP · Published · 2018-06 · Application 31569256
Published · 2018-06 · Application 1020257036689
Rejected · 2018-06 · Application 1020197038067
PCT · Published · 2016-08 · Application PCT/KR2016/009722
PCT · Published · 2016-05 · Application PCT/KR2016/005715
PCT · Published · 2016-05 · Application PCT/KR2016/005274
PCT · Published · 2016-04 · Application PCT/KR2016/004121
PCT · Published · 2016-03 · Application PCT/KR2016/002070
EP · Registered · 2015-04 · Application 15776821.9
CN · Published · 2015-04 · Application 201580016461.0
Registered · 2015-04 · Application 1020167030835
US · Registered · 2015-04 · Application 15129657
PCT · Published · 2015-04 · Application PCT/KR2015/003530
JP · Registered · 2015-04 · Application 28561662
EP · Registered · 2014-11 · Application 14862419.0
CN · Published · 2014-11 · Application 201480060553.4
Registered · 2014-11 · Application 1020167015696
US · Registered · 2014-11 · Application 15029852
PCT · Published · 2014-11 · Application PCT/KR2014/010972
JP · Registered · 2014-11 · Application 28554157
PCT · Published · 2013-09 · Application PCT/KR2013/008229
PCT · Published · 2013-08 · Application PCT/KR2013/007728
CN · Published · 2013-02 · Application 201380018765
US · Registered · 2013-02 · Application 14377087
PCT · Published · 2013-02 · Application PCT/KR2013/000954
PCT · Published · 2011-06 · Application PCT/US2011/039420
CN · Published · 2008-01 · Application 200880007800
EP · Published · 2008-01 · Application 08719395.9
US · Published · 2008-01 · Application 12523285
PCT · Published · 2008-01 · Application PCT/IB2008/000773
JP · Published · 2008-01 · Application 21546026
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How to connect (MCP)Companies in the same categoryBiotech & Drug Discovery
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EDGC, a Korea-US joint venture of Eone Medical Foundation and Diagnomics, offers the NIPT service NICE and liquid biopsy OncoCatch.
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A holding company overseeing 54 affiliates including its main biopharmaceutical subsidiary GC, with no direct product manufacturing of its own.
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KOSDAQ-listed biotech company developing molecular diagnostics with proprietary C-Tag technology and the NeoPlex product line.
SillaJen, Inc., founded in 2006 and listed on KOSDAQ in 2016, develops the oncolytic virus immunotherapy Pexa-Vec.
A vaccine specialist developing in-house products such as SKYCellflu and SKYZoster while also serving as CDMO for AstraZeneca and Novavax.
Sources and updates
Counts on this page are not company-reported figures. MAA matched records from DART, the Korean MFDS, the US FDA, ClinicalTrials.gov, PubMed and KIPRIS to this company itself, by business registration number or registered name, never by name similarity. They may differ from figures the company publishes.
- Company basics
- Korea Exchange · DART
- Business content
- Compiled from disclosure filings
- Approvals & clinical trials
- Korean MFDS (data.go.kr) · US FDA openFDA — updated weekly
- Key disclosures
- KRX KIND via OpenDART exchange filings — updated daily
- Global clinical trials
- ClinicalTrials.gov (US NIH) — sponsor-matched, updated weekly
- Financials
- DART corporate disclosure filings — annual
- Publications
- PubMed (US National Library of Medicine) — affiliation-matched, updated daily
- Patents
- KIPRIS (Korea Institute of Patent Information) — applicant-matched, updated monthly
- AI reads
- Our server logs, IP-verified every 6 hours
- AI visibility
- Measured 2026-10-01
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