Pipeline
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Therapeutic Area | Project Code | Target Indication | Development Stage | ||||
---|---|---|---|---|---|---|---|
Lead | NME | Clinical | NDA | Product | |||
Liver Disease | BESIVO | Hepatitis B | |||||
ID119031166 | NASH | ||||||
ID119050134 | Hepatic cirrhosis | ||||||
CNS | lasmiditan | Migraine | |||||
Oncology | venadaparib | Breast Cancer | |||||
ID11902 | Solid Tumor | ||||||
ID11916 | Breast Cancer | ||||||
Metabolic Disease | IDG16177 | Type-2 Diabetes | |||||
ID110521156 | Type-2 Diabetes | ||||||
Ophthalmology | IDB0062 | Wet AMD | |||||
ID110410395 | Dry Eye Disease | ||||||
ID119010018 | Glaucoma | ||||||
Respiratory Disease | ID119010023 | Respiratory diseases | |||||
Gastrointestinal Disease | ID120040002 | GERD |
Liver Disease
ID119031166
• A potent non-steroidal FXR agonist to treat NASH:
- Mechanism of action that inhibits the synthesis of bile acid
- Strong activity and selectivity demonstrated in nonclinical studies
- Significantly reduced NAFLD Activity score and fibrosis in animal models of NASH
- Regulated direct FXR target genes in a dose-dependent manner in vivo
- Not importantly altered plasma level of ALT/AST and LDL-C at the effective dose
• IND submission expected in Q2 2022
NASH : NonAlcoholic
SteatoHepatitis, NAFLD
: NonAlcoholic Fatty Liver Disease,
FXR : Farnesoid X
Receptor, ALT :
Alanine aminotransferase,
AST : Aspartate
aminotransferase, LDL-C
: Low-Density Lipoprotein Cholesterol
CNS
LASMIDITAN
• Migraine therapy with an innovative mechanism of
action with no restrictions on use in cardiovascular disease
patients
- The first and only Ditan drug
approved by the FDA with a different mechanism from triptans
(serotonin 1B receptor agonists) and NSAIDs, which have been
used as migraine treatments.
- Overcoming the
limitations of existing triptans (limited use in
cardiovascular patients) by exhibiting 470-fold or more
affinity for serotonin 1F receptors compared to serotonin 1B
and 1D receptors associated with vasoconstriction
• NDA submitted in Korea in Q1 2021
NSAIDs : Non-steroidal anti-inflammatory drugs
Metabolic Disease
IDG16177
• A GPR40 agonist to treat type 2 diabetes mellitus
- High oral absolute bioavailability in
pre-clinical species
- A defined MoA,
activating β-arrestin2 recruitment as well as Gq-dependent
pathway
-
- Superior
to fasiglifam in glucose reduction in normal and diabetic
rat studies
- Potentially no risk
of DILI (drug-induced liver injury)
• Phase
1 has started in Germany in July 2021 to evaluate safety
and pharmacokinetics (NCT04982705)
Metabolic Disease
ID110521156
•A small-molecule glucagon-like peptide (GLP)-1 receptor agonist to treat type 2 diabetes
- Being developed as an oral drug
- Overcame the disadvantages of existing injection drugs (improved safety profile and
patient adherence)
- Potential of expansion to various indications including NASH and Obesity
• IND submission expected in Q1 2023
GLP-1 : Glucagon-like peptide-1, NASH : NonAlcoholic SteatoHepatitis
Ophthalmology
IDB0062
• A dual-targeting antibody fragment drug for wet AMD
- A VEGF-A/NRP1 dual-targeting antibody fragment engineered through tissue-penetrating
peptide technology
- Enhanced efficacy by inhibiting multiple pro-angiogenic growth factors
- Targets bi- to tri-monthly dosing interval based on improved ocular PK
- Possibility of non-invasive drug administration through tissue-penetrating peptides
• No known systemic safety issues by GLP tox study
• Pre-clinical development accelerated through Lonza’s CMC platform
• Accelerating CMC development with Global CDMO
Ophthalmology
ID110410395
• First-in-class small molecule CFTR activator to
treat dry eye disease
- has a novel
mode of action to increase tear secretion
-
targets to improve both signs and symptoms with favorable
tolerability profile and simplified dosing
• IND submission expected in Q4 2022
CFTR : Cystic Fibrosis Transmembrane Regulator
Ophthalmology
ID119010018
• A nitric oxide-donating PDE5 inhibitor for Glaucoma
- Metabolized in the body to release nitric oxide and at the same time inhibits PDE5/6 to
increase PKG (protein kinase G) activity
- Activates PKG by increasing the amount of cGMP by inhibiting the degradation of cGMP
- Activated PKG relaxes smooth muscle and increases blood flow
cGMP : Cyclic Guanosine MonoPhosphate
Respiratory Disease
ID119010023
• A nitric oxide-donating PDE5 inhibitor for ARDS, PAH
- Highly selective and potent in vitro activity
- Efficacy shown in an acute lung injury mouse model
• in vivo efficacy study, formulation, PK analysis are on-going
• IND submission expected in 1Q 2023
ARDS : Acute Respiratory Distress Syndrome, PDE5 : PhosphoDiEsterase 5
* HBV polymerase inhibitor : Regulatory approval in Korea in May 2017 The 28th domestic new drug
* GPR40 agonist : Clinical Trial Application (CTA) approval in June 2021 in Germany
