Drugs / K-CAB
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | K-CAB | active peptic ulcer disease | 2026-01-09 | “In January this year, HK inno.N’s U.S. partner Sebela Pharmaceuticals submitted a New Drug Application to the U.S. Food and Drug Administration (FDA)” inno-n.com ↗ “HK inno.N's US partner Sebela filed an NDA application for K-CAB with the FDA on January 9 (local time).” inno-n.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT04654078 | Jan → Feb 2021 | — | HK inno.N Corporation | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 22
| Date | Issuer | Release |
|---|---|---|
| 2026-07-27 | HK inno.N Corporation | Regulatory HK inno.N Adds Sixth Indication for K-CAB — Broadest Label among P-CABs in South Korea inno-n.com ↗
The company announced on the 27th that the Ministry of Food and Drug Safety (MFDS) granted approval for a new indication of K-CAB, “the prevention of NSAID-associated peptic ulcers” |
| 2026-05-06 | HK inno.N Corporation | Results K-CAB, HK inno.N’s New GERD Treatment, Announces U.S. Phase 3 Clinical Trial Results at the 2026 DDW inno-n.com ↗
The results from US Phase 3 clinical trials for K-CAB (ingredient name: Tegoprazan), HK inno.N’s new gastroesophageal reflux disease (GERD) drug, have been presented recently, laying the groundwork for the product’s launch in the world's largest pharmaceutical market. |
| 2026-01-19 | HK inno.N Corporation | Regulatory K-CAB, HK inno.N’s new novel drug for GERD treatment, submits an NDA to the U.S. FDA. inno-n.com ↗
K-CAB, HK inno.N’s new novel drug for GERD treatment, submits an NDA to the U.S. FDA. |
| 2025-11-27 | HK inno.N Corporation | Results Dr. Felice Schnoll-Sussman, Highlights K-CAB’s U.S. Market Potential at KDDW 2025 inno-n.com ↗
In the maintenance therapy trial for EE, K-CAB met its primary endpoint by demonstrating a high remission maintenance rate over 24 weeks. |
| 2025-10-15 | HK inno.N Corporation | Results HK inno.N Presents Clinical Results of Novel GERD Drug ‘K-CAB’ for H. pylori Eradication at UEGW inno-n.com ↗
HK inno.N Presents Clinical Results of Novel GERD Drug ‘K-CAB’ for H. pylori Eradication at UEGW |
| 2025-08-08 | HK inno.N Corporation | Results HK inno.N’s Novel Drug K-CAB Succeeds in U.S. Phase 3 Trial … Moving Toward FDA Submission inno-n.com ↗
K-CAB (tegoprazan) demonstrated statistically superior remission maintenance rates compared with lansoprazole in all patients with erosive esophagitis (EE) and in those with moderate to severe disease |
| 2025-04-23 | HK inno.N Corporation | Results HK inno.N Announces Positive Topline Results from US Phase 3 Trials of K-CAB (tegoprazan) inno-n.com ↗
K-CAB achieved all primary and secondary endpoints in trials for both erosive esophagitis (EE) and non-erosive reflux disease (NERD). |
| 2025-02-06 | HK inno.N Corporation | Regulatory HK inno.N’s K-CAB® wins a landmark victory in the second-instance trial for its substance patent inno-n.com ↗
Intellectual Property High Court also ruled in favor of HK inno.N, the originator company, which indicates that K-CAB® is granted patent protection until 2031. |
| 2024-12-02 | HK inno.N Corporation | Regulatory K-CAB, HK inno.N’s new GERD treatment received recommendation for marketing authorization in India inno-n.com ↗
HK inno.N announced on Monday (December 2nd) that it received a recommendation for granting marketing authorization of its gastroesophageal reflux disease (GERD) treatment, K-CAB Tablet, from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) of India. |
| 2024-09-26 | HK inno.N Corporation | Regulatory K-CAB, HK inno.N’s new GERD treatment approved in Malaysia inno-n.com ↗
HK inno.N announced on September 26 that K-CAB (tegoprazan) obtained marketing authorization (MA) from National Pharmaceutical Regulatory Agency (NPRA) of Malaysia. |
| 2024-09-02 | HK inno.N Corporation | Regulatory K-CAB reports substantial progress of its market expansion in Central and South America inno-n.com ↗
HK inno.N announced on September 2nd that its new drug for gastroesophageal reflux disease (GERD), "K-CAB," has achieved a significant milestone in its global market expansion by obtaining marketing authorization (MA) in six Latin American countries including Colombia. |
| 2024-05-27 | HK inno.N Corporation | Results HK inno.N presents newest research findings of its new drug “K-CAB” at the DDW 2024 inno-n.com ↗
HK inno.N releases new research results of K-CAB, a new P-CAB drug, at the DDW 2024. |
| 2024-02-20 | HK inno.N Corporation | Regulatory K-CAB, HK inno.N’s new drug for GERD treatment, obtains marketing authorization from Chile inno-n.com ↗
HK inno.N announced on the 20th that K-CAB (ingredient: tegoprazan), a new drug for GERD treatment, recently obtained marketing authorization from the National Drug Agency (Departamento Agencia Nacional de Medicamentos, ANAMED) under the Public Health Institute (ISP) of Chile. |
| 2023-12-21 | HK inno.N Corporation | Results HK inno.N displays distinctive K-CAB clinical trial results inno-n.com ↗
The study results showed that K-CAB did not affect the minimum plasma concentration of immunosuppressants. |
| 2023-11-20 | HK inno.N Corporation | Results At KDDW 2023, HK inno.N’s K-CAB has emerged as a trailblazer in strengthening its global position inno-n.com ↗
On November 20th, the bio-pharmaceutical company HK inno.N (CEO: Kwak Dalwon), announced the company's participation in the 7th Korea Digestive Disease Week (referred to as “KDDW 2023”). |
| 2023-07-24 | HK inno.N Corporation | Regulatory HK inno.N's new drug for gastroesophageal reflux disease K-CAB, receives approval in Peru inno-n.com ↗
HK inno.N has obtained product approval for its new drug 'K-CAB' for gastroesophageal reflux disease in Peru. |
| 2023-07-03 | HK inno.N Corporation | Regulatory National Health Insurance to reimburse K-CAB’s H.pylori Eradication Indication Prescription inno-n.com ↗
HK inno.N announced on Jul. 3rd that starting from Jul. 1st, K-CAB will be eligible for national health insurance coverage when used in combination therapy with antibiotics for Helicobacter pylori eradication in patients with peptic ulcers. |
| 2023-05-17 | HK inno.N Corporation | Results HK inno.N presents latest research results of K-CAB to gastroenterologists worldwide inno-n.com ↗
As a result, K-CAB proved non-interiority in the healing of iatrogenic ulcer compared to esomeprazole, a PPI and showed a higher healing rate (30.3% vs 22.1%)at the 4-week mark. |
| 2022-11-28 | HK inno.N Corporation | Results HK inno.N presents K-CAB big data hepatotoxicity inno-n.com ↗
The study showed that K-CAB had a 27% lower risk of hepatotoxicity compared to six competitor PPI drugs. |
| 2021-06-08 | HK inno.N Corporation | Regulatory HK inno.N’s new drug K-CAB is approved of a phase1 inno-n.com ↗
HK inno.N announced that it recently received approval of a phase 1 clinical trial of K-CAB Tab.(ingredient: tegoprazan) in the U.S. from the U.S. FDA. |
| 2021-05-17 | HK inno.N Corporation | Regulatory K-CAB h.pylori eradication indication added inno-n.com ↗
CJ HealthCare (CEO Kang, Seok - Hee), a subsidiary Kolmar Korea, recently announced that it has been approved by the Ministry of Food and Drug Safety for the additional indication of K-CAB Tab. |
| 2019-03-18 | HK inno.N Corporation | Results CJ Healthcare host K-CAB launch symposium inno-n.com ↗
K-CAB tablets showed gastric acid secretion inhibition on the first day of intake. |
All press releases naming this drug 43 releases
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | K-CAB | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04654078 ↗ |