[헬스코리아뉴스 / 이충만] In the anti-ulcer drug market, a new PPI + antacid combination new craze is heating up. As Chong Kun Dang completed preparations for the launch of the low-content PPI + antacid ‘Esoduo S Tab’ (Esomeprazole magnesium trihydrate + sodium bicarbonate), Added dosing flexibility. As a result of the coverage of this magazine, it was confirmed that the Ministry of Food and Drug Safety approved the marketing of 10 medicines, including ‘Esoduo S Tab.’, and approved six clinical trials on the 21st and 22nd.
PPI (Proton Pump Inhibitor) is a drug that reduces gastric acid secretion by inhibiting the proton pump that secretes gastric acid from the cells of the stomach lining, and is used for the treatment of gastroesophageal reflux disease and gastric ulcer. Examples include ▲rabeprazole, ▲omeprazole, ▲esomeprazole, ▲pantoprazole, ▲lansoprazole, and delansoprazole.
PPI-only preparations have disadvantages in that drug effects do not appear immediately and acid secretion cannot be prevented at night. Accordingly, pharmaceutical companies have introduced new drug combinations that combine PPI preparations with sodium bicarbonate, an antacid, to quickly develop medicinal effects and suppress acid secretion at night.
The most representative product is Chong Kun Dang’s ‘Eso Duo’. Esoduo is a combination of esomeprazole and sodium bicarbonate, a fast-acting reflux esophagitis treatment that Chong Kun Dang introduced for the first time in the world in 2018. In 2018 and 2019, the company received item permission from the Ministry of Food and Drug Safety for two doses of ‘Esoduo Tab’ (20 mg of Esomeprazole + 800 mg of sodium bicarbonate, 40 mg of Esomeprazole + 800 mg of sodium bicarbonate).
Chong Kun Dang intends to increase patients’ flexibility in taking the drug by slightly reducing the content of sodium bicarbonate. The Ministry of Food and Drug Safety approved two doses of ‘Esoduo S Tab.’ (Esomeprazole 20mg + Sodium Bicarbonate 700mg, Esomeprazole 40mg + Sodium Bicarbonate 700mg) as prescription drugs (drugs for data submission), which were lowered from the previous 800mg to 700mg. Through this, it is expected that side effects of sodium bicarbonate, such as irritation of the gastric mucosa and water retention in the body, can be managed flexibly.
The indications for ‘Esoduo S Tab.’ are the same as ‘Esoduo Tab.’ ▲ Treatment of erosive reflux esophagitis ▲ Long-term maintenance therapy to prevent recurrence in patients with esophagitis ▲ Symptomatic therapy for gastroesophageal reflux disease without esophagitis.
Below is a list of approval status and clinical trials of drugs approved on the 21st and 22nd.
▼Clinical trial approval list
|
company |
product name |
Clinical Trial Title |
clinical trial phase |
implementing agency |
|
Chong Kun Dang |
CKD-348 |
Evaluation of tolerability and pharmacokinetics of CKD-828, D097 and D337 combined administration and CKD-348(5) monotherapy in healthy adult volunteers |
Phase 1 |
H+ Yangji Hospital |
|
Kyung Hee University Oriental Medicine Hospital |
Kwak Jung Tanggami |
Exploring the efficacy and safety of Kwakjeongtangami for patients with diarrhea-type irritable bowel syndrome |
researcher clinical trial |
Kyung Hee University Oriental Medicine Hospital |
|
Gilead Sciences Korea |
GS-5245 |
Evaluating the efficacy and safety of GS-5245 as a treatment for COVID-19 in subjects at high risk of disease progression |
Phase 3 |
5 institutions including Chonnam National University Hospital |
|
J.W. Shinyak |
JW0401 |
Comparative evaluation of pharmacokinetic properties and safety of JW0401 and C2208 administration in healthy adults |
live |
Bumin Hospital |
|
HK Innoen |
IN-C004 |
Comparative evaluation of pharmacokinetic properties and safety according to the route of administration of IN-C004 in healthy adult male volunteers |
Phase 1 |
Inje University Busan Paik Hospital |
|
Hanlim Pharmaceutical |
Lodenti Plus Tab. 80/2.5/25mg (Telmisartan, Escamlodipine Nicotinate, Chlorthalidone) |
Evaluation of safety and pharmacokinetic properties of Rhodienti Plus 80/2.5/25mg administration to healthy adult volunteers |
Phase 1 |
Chung-Ang University Gwangmyeong Hospital |
▼ Drug approval list
|
product name |
company name |
Indications |
Permission review type |
|
Dapagreen designated 10/4mg |
Jinyang Pharmaceutical |
Administered as an adjunct to diet and exercise therapy to improve blood sugar control in type 2 diabetic patients for whom combined administration of glimepiride and dapagliflozin is appropriate |
Prescription drugs (drugs for data submission) |
|
Esoduo S Tab. 20/700mg |
Chong Kun Dang |
Gastroesophageal Reflux Disease (GERD) |
Prescription drugs (drugs for data submission) |
|
Esoduo S Tab. 40/700mg |
Chong Kun Dang |
Gastroesophageal Reflux Disease (GERD) |
Prescription drugs (drugs for data submission) |
|
Maxtamine Mega Max Tab. |
anecdote |
Supply of vitamins D, E, B1, B2, B6, C |
Over-the-counter drugs (standard manufacturing standards) |
|
Nozkov Soft Capsule |
Taegeuk Pharmaceutical |
Alleviation of cold symptoms |
Over-the-counter drugs (standard manufacturing standards) |
|
Youyoung Pravapen Capsule |
Yooyoung Pharmaceutical |
Treatment of complex dyslipidemia with high triglyceride levels and low HDL-cholesterol levels with adequate control of LDL-cholesterol levels during monotherapy with pravastatin 40 mg in adult patients at high risk of coronary heart disease (CHD) |
Prescription drug (generic) |
|
Oakley Bean Nasal Spray |
New One Science |
Relief of symptoms caused by a cold (acute rhinitis), allergic rhinitis or sinusitis |
Over-the-counter drugs (standard manufacturing standards) |
|
Jimin S Tab. |
Han Poong Pharmaceutical |
Hives, eczema, itching, poison ivy |
Over-the-counter drugs (generic) |
|
Kunil Estradiol Valerate Tab. |
Kunil Pharmaceutical |
Hormone replacement therapy for menopausal symptom relief in postmenopausal women, prevention of osteoporosis in women prone to fractures |
Prescription drug (generic) |
|
Dafaensita Tab. 10/100mg |
COSMAX Pharma |
Administered as an adjunct to diet and exercise therapy to improve glycemic control in type 2 diabetic patients for whom co-administration of sitagliptin and dapagliflozin is appropriate |
Prescription drug (generic) |
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