ABOUT US Towards better quality of life, GNT Pharma
History
2021
01.
Nelonemdaz: Domestic and international patent applications as an injection
01.
Crisdesalazine: Designated as an orphan drug for Lou Gehrig’s disease in South Korea
02.
Crisdesalazine: Designated as an orphan drug for Lou Gehrig’s disease in Europe
03.
Nelonemdaz: Patient enrollment completed for the phase 2 clinical trial (AWAKE) on cardiac arrest
04.
Nelonemdaz: Patient enrollment completed for the phase 3 clinical trial (RODIN) on stroke
06.
Crisdesalazine: Domestic and international patent applications on the manufacturing methods and crystalline form
07.
Crisdesalazine: IND application for phase 2 clinical trial on Alzheimer’s dementia
07.
GedaCure: IND application for canine epilepsy
08.
Nelonemdaz: Registration of USA patent on the use and formulation of derivatives
09.
GSTCH Research Lab was opened in the Yonsei University International Campus
12.
Crisdesalazine: Domestic patent application for autoimmune disease
2022~
04.
Crisdesalazine: Clinical phase 1b dosing has been completed
05.
Gedacure: Selected by the Ministry of Agriculture, Food and Rural Affairs as the “Cultivation Support Project of Export Innovation Category”
08.
Crisdesalazine: Selected for the “Full Life-Cycle Support Project for Global Promotion and Strengthening of the Pharmaceutical Industry” of Korea Health Industry Development Institute
09.
Nelonemdaz: Paper on phase 2 clinical study has been published in “Stroke”, an international academic journal
10.
Crisdesalazine: Designated as an orphan drug for Lou Gehrig’s disease in the USA
12.
Radipair: Marketed
12.
Flusalazine: USA/PCT international patent applications as a therapeutic agent for respiratory diseases
2021
02.
Crisdesalazine / GedaCure: Approved as a treatment for CCDS in South Korea – South Korea’s first synthetic new veterinary drug
03.
Nelonemdaz: U.S./PCT international patent application filed for use in the treatment of stroke with reperfusion
05.
GedaCure: GNT Pharma and Yuhan Corporation launch marketing in South Korea
08.
Nelonemdaz: IND approved in South Korea for phase III trial in stroke patients treated with endovascular thrombectomy (RODIN)
11.
Crisdeslazine: Initiation of Phase 1b testing in South Korea
12.
Flusalazine: Priority patent application filed with the US Patent and Trademark Office covering use in COPD and asthma
2020 ~ 2016
01.
Crisdesalazine: Completion of Phase III SMART trial in dogs with CCDS
02.
Crisdesalazine: Product license application filed for marketing as Gedacure to treat CCDS
03.
Nelonemdaz: Completion of patient enrollment for Phase II SONIC stroke trial
03.
Nelonemdaz: U.S. Priority Patent Application filed for use in the treatment of stroke with reperfusion
04.
Nelonemdaz: Award granted from the Ministry of Health and Welfare to support Phase II AWAKE trial in cardiac arrest
05.
TFM: Completion of human clinical trials as a cosmetic treatment for wrinkles and skin hyperpigmentation
10.
Nelonemdaz: Completion of Phase II SONIC stroke trial in South Korea
12.
Nelonemdaz: Initiation of patient enrollment for Phase III ENIS stroke trial (ENIS) in China
01.
Nelonemdaz: Completion of Phase II ENIS trial in stroke (238 people)
01.
Nelonemdaz: Initiation of Phase II AWAKE trial in cardiac arrest patients
01.
Crisdesalazine: U.S. Priority Patent application filed for use in CCDS
01.
Brain Science Park conference held
02.
Crisdesalazine: Approval granted in South Korea for Phase III trial in dogs with CCDS (SMART)
07.
Trifluoromethylphenethyl mesalazine (TFM) listed in the International Ingredient Dictionary and Handbook and patent application filed covering dermatological uses
12.
Nelonemdaz: Designated as an Orphan Drug in Development Stage by the Ministry of Food and Drug Safety of South Korea
12.
Dementia and stroke new drug clinical presentation held
(Suwon Convention Center)
06.
Nelonemdaz: Phase II trial in cardiac arrest (AWAKE) initiated
07.
Brain Science Park creation agreement signed
08.
Crisdesalazine: demonstrated cognitive benefit in dogs with canine cognitive dysfunction syndrome (CCDS)
09.
Brain science development forum held
10.
GNT Pharma won the Money Today “Bio Grand Prize”
11.
Crisdesalazine: Memorandum of understanding signed with Chinese partner Ledun Technology for marketing in China
05.
Nelonemdaz: Approval granted by the KFDA in South Korea for Phase II study in patients resuscitated after out-of-hospital cardiac arrest (AWAKE)
08.
GNT Pharma and Apeloa Pharmaceuticals sponsored an international symposium focusing on stroke and possible use of nelonemdaz to treat stroke
01.
Nelonemdaz: Patent application for compound and use filed in the E.U.
01.
Nelonemdaz: Submission of report on the results of the Phase 1 study in China; IND application submitted for Phase 2 clinical trial in acute stroke patients treated with medical thrombolysis (ENIS)
02.
The 1st GNT Pharma Forum for stroke held at the Catholic University of Korea, College of Medicine
05.
Nelonemdaz: Approval granted by the MFDS (Ministry of Food and Drug Safety) in South Korea for Phase II study in acute stroke patients treated with endovascular thrombectomy (SONIC)
09.
Nelonemdaz: Approval granted by the CFDA in China for Phase II study in stroke (ENIS)
10.
Acquisition of a new head office and R&D Center located in Yongin-si
2015 ~ 2011
01.
GNT Pharma and Apeloa Pharmaceuticals selected by the China Science and Technology Innovation Team
Nelonemdaz: Completion of Phase I study with 70 healthy subjects in China
04.
Nelonemdaz: Patent application filed in Japan for use in the treatment of burn injury
04.
Crisdesalazine: Synthesis patent applications filed in the U.S. and Japan
06.
Nelonemdaz: Patent application filed in China for use in the treatment of burn injury
10.
Nelonemdaz: Approval granted in China for clinical trials
11.
Crisdesalazine: Patent application filed in the E.U. and Japan for use in the treatment of depression
06.
Crisdesalazine: Synthesis patent application filed in China
12.
Flusalazine: Patent applications filed in the U.S., China, and Japan for use in the treatment of inflammatory diseases and pain
07.
Nelonemdaz: Patent application filed in South Korea for use in the treatment of burn injury
07.
Crisdesalazine: Synthesis patent application filed in the EU
07.
Flusalazine: Patent application filed in South Korea for use in the treatment of inflammatory diseases
04.
Nelonemdaz: KFDA approval granted for a Phase II study in acute stroke patients in South Korea
07.
Nelonemdaz: Submission and revision of IND and NDA to SFDA for clinical trials in China
Crisdesalazine: Successful completion of Phase Ia study in South Korea
2010 ~ 2006
- Nelonemdaz: Patent application for the treatment of burn injury filed in Korea
- Crisdesalazine: Compound patent application filed in the U.S., Japan, and China
- Crisdesalazine: Initiation of Phase Ia study in South Korea
- Crisdesalazine: KFDA approval granted for a Phase Ia study in South Korea
- Crisdesalazine: Compound and use patent application filed in Canada
- Nelonemdaz: Patent application covering synergistic use with brain-derived neurotrophic factor filed in the U.S.
- Flusalazine: Compound and use (treatment of pain and inflammatory diseases) patent application filed in South Korea
- Nelonemdaz: Partnering and licensing deals with Jiayuan Pharmaceuticals for marketing in China
- Successful completion of nelonemdaz Phase I study in the U.S.
- Nelonemdaz: Compound and use patent applications filed in Japan and the U.S.
- Flusalazine (ND-07) discovered as a drug candidate for the treatment of pain and inflammatory diseases
- Establishment of GNT’s business office at Gyeonggi Biocenter
- Grant Award (National R&D Project Award) from the Ministry of Health & Welfare (2006-2009)
Development of crisdesalazine for the Treatment of Alzheimer’s Disease - Grant Award (21C Brain Frontier Project) from MOST (2006-2009)
Drug discovery for the Treatment of Neuropathic Pain - Nelonemdaz: Phase I study initiated in the U.S.
2005 ~ 2001
- Nelonemdaz: Completion of pre-clinical safety study
- Crisdesalazine (AAD-2004) discovered as a drug candidate for the treatment of Alzheimer’s and other neurodegenerative diseases.
- Grant Award (Driving Force Project for the Next Generation) from the Gyeonggi Provincial Government (2004-2009)
Drug Discovery and Development for the Treatment of Spinal Cord Injury
- Nelonemdaz: Patent application for compound and use filed in South Korea
- Grant Award (21C Brain Frontier Project) from MOST
Drug discovery for Alzheimer’s disease (2003-2006) - Grant Award (21C Proteomics Frontier Project) from MOST
Application of proteomics for prevention and treatment of ischemic brain injury
- Nelonemdaz: Completion of efficacy study in animal models of stroke
2000 ~ 1998
- Patent application for a multi-target brain cell protection drug library
- GNT Pharma designated as “Venture Business” by the Small and Medium Business Administration.
- Grant Award (National Research Laboratory) from MOST (1999-2004)
Study for the Interventional Therapy of Stroke and Alzheimer’s Disease - Grant Award (National Research Laboratory) from MOST (1999-2004)
Eye Research Laboratory
- GNT Pharma was founded on April 3.
- Grant Award (G7 Project) from the Ministry of Science & Technology (MOST)
Development of animal models and therapeutic approaches for Alzheimer’s Disease (1998-2002) - Grant Award (Science Research Center) from MOST
Brain Disease Research Center (1998-2007)