Drugs / Enavogliflozin
Enavogliflozin
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Other | — | type 2 diabetes mellitus | 2024-04-26 | “submission of a New Drug Application (NDA) for their Enavogliflozin to the COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) in Mexico” daewoong.co.kr ↗ |
| Filed | Other | Enavogliflozin | type 2 diabetes mellitus | 2023-10-20 | “Envlo accomplished to submit the NDA in five countries such as Indonesia, Philippines, Thailand, Vietnam and Saudi Arabia” daewoong.co.kr ↗ “Enavogliflozin, Daewoong Pharmaceutical's diabetes treatment, applied for product registration in Saudi Arabia” daewoong.co.kr ↗ |
| Filed | Other | Envlo | type 2 diabetes mellitus | 2023-03-23 | “submitted a new drug application (NDA) in Indonesia, Philippines and Thailand, the largest markets in Southeast Asia for Envlo” daewoong.co.kr ↗ “Envlo accomplished to submit the NDA in five countries such as Indonesia, Philippines, Thailand, Vietnam and Saudi Arabia” daewoong.co.kr ↗ “After the fast-track review, the NDA (New drug application) of Enavogliflozin was submitted in March 2022” daewoong.co.kr ↗ |
Trials 33
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 113 trials | ||||||
| Phase 1 | NCT07213310 | Nov 2025 → Jan 2026 | — | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 1 | NCT06644404 | Oct → Dec 2024 overdue | — | Daewoong Pharmaceutical Co. LTD. | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT05747664 | Apr 2023 → Apr 2024 | type 2 diabetes mellitus | Daewoong Pharmaceutical Co. LTD. | Unknown | No outcome recorded |
| Phase 1 | NCT05797922 | Mar → May 2023 | — | Daewoong Pharmaceutical Co. LTD. | Unknown | No outcome recorded |
| Phase 1 | NCT05737771 | Jan → Mar 2023 | type 2 diabetes mellitus | Daewoong Pharmaceutical Co. LTD. | Unknown | No outcome recorded |
| Phase 1 | NCT05500898 | Aug → Oct 2022 | — | Daewoong Pharmaceutical Co. LTD. | Unknown | No outcome recorded |
| Phase 1 | NCT05192395 | Apr → May 2022 | — | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 1 | NCT05207176 | Feb → Apr 2022 | — | Daewoong Pharmaceutical Co. LTD. | Unknown | No outcome recorded |
| Phase 1 | NCT05321732 | Dec 2021 → Aug 2022 | — | Daewoong Pharmaceutical Co. LTD. | Unknown | No outcome recorded |
| Phase 1 | NCT04343547 | Apr → Jul 2020 | — | Daewoong Pharmaceutical Co. LTD. | Unknown | No outcome recorded |
| Phase 1 | NCT04221399 | Jan → Aug 2020 | type 2 diabetes mellitus | Daewoong Pharmaceutical Co. LTD. | Unknown | No outcome recorded |
| Phase 1 | NCT04064073 | Aug → Nov 2019 | — | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 1 | NCT03364985 | Dec 2017 → May 2019 | — | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT04014023 | Jul 2019 → Mar 2020 | type 2 diabetes mellitus | Daewoong Pharmaceutical Co. LTD. | Unknown | No outcome recorded |
| Phase 311 trials · 2 met primary | ||||||
| Phase 3 | NCT07619833 | Jun 2026 → Nov 2027 expected | type 2 diabetes mellitus | Daewoong Pharmaceutical Co. LTD. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06606093 | Sep 2024 → Sep 2026 overdue | diabetic kidney disease | Daewoong Pharmaceutical Co. LTD. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06141980 | Dec 2023 → Sep 2025 | type 2 diabetes mellitus | Daewoong Pharmaceutical Co. LTD. | Unknown | No outcome recorded |
| Phase 3 | NCT06027307 | Oct 2023 → Jun 2027 expected | heart failure, tricuspid valve insufficiency | Asan Medical Center | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05466643 | Mar 2023 → Sep 2024 | type 2 diabetes mellitus | Daewoong Pharmaceutical Co. LTD. | Unknown | Met primary |
| Phase 3 | NCT05505994 | Sep 2022 → Feb 2024 | type 2 diabetes mellitus | Daewoong Pharmaceutical Co. LTD. | Unknown | No outcome recorded |
| Phase 3 | NCT05376930 | Sep 2021 → May 2022 | type 2 diabetes mellitus | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 3 | NCT05376969 | May 2021 → May 2022 | type 2 diabetes mellitus | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 3 | NCT04654390 | Dec 2020 → Dec 2021 | type 2 diabetes mellitus | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 3 | NCT04634500 | Nov 2020 → Nov 2021 | type 2 diabetes mellitus | Daewoong Pharmaceutical Co. LTD. | Completed | Met primary |
| Phase 3 | NCT04632862 | Nov 2020 → Nov 2021 | type 2 diabetes mellitus | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 48 trials | ||||||
| Phase 4 | NCT07240844 | Jan 2026 → Apr 2027 expected | amyloidosis | Seoul St. Mary's Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06528262 | Apr 2025 → May 2027 expected | atrial fibrillation | Yonsei University | Recruiting | No outcome recorded |
| Phase 4 | NCT06782139 | Jan → Dec 2025 overdue | type 2 diabetes mellitus | Korea University Anam Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT05672836 | Dec 2024 → Dec 2028 expected | aortic valve stenosis, heart failure | Duk-Woo Park, MD | Recruiting | No outcome recorded |
| Phase 4 | NCT06580717 | Oct 2024 → Nov 2026 expected | hypertrophic cardiomyopathy | Yonsei University | Recruiting | No outcome recorded |
| Phase 4 | NCT06350487 | May 2024 → Dec 2025 | heart failure | Samsung Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT06399835 | Feb 2024 → Dec 2026 expected | type 2 diabetes mellitus | Seoul National University Bundang Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06642623 | Jan 2024 → Sep 2029 expected | cardiovascular disorder, kidney disorder, type 2 diabetes mellitus | Yonsei University | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2024-07-12 | Daewoong Pharmaceutical Co. LTD. | Results Daewoong Pharmaceutical Presented Superiority of Enavogliflozin at 84th ADA Scientific Sessions daewoong.co.kr ↗
After 24 weeks of treatment, 78.1% of patients on Enavogliflozin achieved an HbA1c level below 7%, compared to 65.7% for dapagliflozin. |
| 2024-06-19 | Daewoong Pharmaceutical Co. LTD. | Results Daewoong Presents Enavogliflozin’s Phase 3 Pooled Analysis Results at 84th ADA Conference daewoong.co.kr ↗
The study shows Enavogliflozin's superior blood glucose-lowering effects compared to dapagliflozin, with a significant reduction in glycated hemoglobin (HbA1c) levels. |
| 2024-04-26 | Daewoong Pharmaceutical Co. LTD. | Regulatory Daewoong Pharmaceutical submits a new drug application (NDA) for Enavogliflozin in Mexico daewoong.co.kr ↗
Daewoong Pharmaceutical (CEO Seongsoo Park, Chang-jae Lee) announced the submission of a New Drug Application (NDA) for their Enavogliflozin to the COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) in Mexico. |
| 2023-07-21 | Daewoong Pharmaceutical Co. LTD. | Regulatory Daewoong Pharmaceutical has obtained approval for SGLT2i + metformin combination drug Envlomet. daewoong.co.kr ↗
Daewoong Pharmaceutical (Jeon Sengho and Lee Chang-jae) announced on the June 14th that Envlomet SR Tab. 0.3/1000mg, (ingredient name: enavogliflozin, metformin hydrochloride) has obtained the approval on June 13th. |
| 2023-05-08 | Daewoong Pharmaceutical Co. LTD. | Results Daewoong Pharmaceutical Announce Publication of Phase 3 Study of ‘Envlo’, a New Treatment for Diabetes, in the International SCIE Journal daewoong.co.kr ↗
It was statistically significant (p<0.0001) that the proportion of subjects achieving a therapeutic glycemic response (HbA1c < 7% or < 6.5%), indicating the potential as an effective diabetes treatment. |
| 2023-03-23 | Daewoong Pharmaceutical Co. LTD. | Regulatory Daewoong Pharmaceutical's Envlo to enter the global market in full swing... Filing for product license in three ASEAN countries daewoong.co.kr ↗
Daewoong Pharmaceutical (CEO Seng-ho Jeon and Lee Chang-jae) recently revealed that they submitted a new drug application (NDA) in Indonesia, Philippines and Thailand, the largest markets in Southeast Asia for Envlo, the SGLT2 enzyme inhibitor type new drug for diabetes. |
| 2022-11-11 | Daewoong Pharmaceutical Co. LTD. | Results Daewoong Pharmaceutical Presents Phase 3 Clinical Trial Results of New Diabetes Treatment ‘Enavogliflozin’ and Roadmap to Enter 50 Countries by 2030 daewoong.co.kr ↗
All three Enavogliflozin phase 3 clinical trials confirmed the efficacy and safety for 24 weeks of dosing. |
| 2022-05-02 | Daewoong Pharmaceutical Co. LTD. | Results Daewoong Pharmaceutical Announces Successful Phase 3 Topline Results for New Antidiabetic Drug’s Triple Combination Therapy daewoong.co.kr ↗ |
| 2022-05-02 | Daewoong Pharmaceutical Co. LTD. | Results Daewoong Pharmaceutical Released Positive Phase 3 Topline Results for New Antidiabetic Drug daewoong.co.kr ↗
According to the topline report, it was preliminarily observed to be 0.99%p at 24 weeks since the administration of the investigational product, which confirmed statistical significance (P-value<0.001). |
| 2020-11-30 | Daewoong Pharmaceutical Co. LTD. | Regulatory Daewoong Pharmaceutical obtains approval for phase-3 clinical trials in South Korea for third indications of new drug Enavogliflozin for diabetes treatment daewoong.co.kr ↗
Daewoong Pharmaceutical (Daewoong) (CEO Sengho Jeon) announced that Daewoong obtained approval for phase-3 clinical trials for combination therapy using the new drugs for diabetes treatment Enavocliflozin as well as metformin and DPP-4 inhibitors on the 30th. |
| 2020-11-23 | Daewoong Pharmaceutical Co. LTD. | Regulatory Daewoong Pharmaceutical’s enavogliflozin monotherapy and metformin combination therapy obtains phase-3 clinical trial approval simultaneously daewoong.co.kr ↗
Daewoong simultaneously obtained phase-3 clinical trial approval for each of their new SLGT2 inhibitor for diabetes treatment—enavogliflozin monotherapy and metformin combination therapy—from the Ministry of Food and Drug Safety, which evaluates the efficacy and safety of each of the treatments. |
| 2020-10-07 | Daewoong Pharmaceutical Co. LTD. | Results Daewoong Pharmaceutical’s enavogliflozin to demonstrate remarkable blood glucose lowering effect and favorable safety in type 2 diabetic patients through phase 2 clinical trial daewoong.co.kr ↗
In week 12, the patients’ glycated hemoglobin levels decreased approximately 0.9%p in comparison to the placebo. |
| 2019-09-20 | Daewoong Pharmaceutical Co. LTD. | Results Daewoong Pharmaceutical presents the clinical results of ‘DWP16001’, the new drug for SGLT-2 diabetes, at the European Association for the Study of Diabetes (EASD). daewoong.co.kr ↗
The phase 1 clinical study proved that DWP16001 can effectively secrete urine glucose with only 1/100 of other drugs in the same series. |
| 2019-05-31 | Daewoong Pharmaceutical Co. LTD. | Regulatory Daewoong Pharmaceutical’s diabetes treatment, ‘DWP16001,’ approved for clinical test phase 2 in Korea. daewoong.co.kr ↗
'DWP16001,’ the new medication for SGLT2 diabetes treatment being developed by Daewoong Pharmaceutical (CEO Sengho Jeon), has been approved by KFDA for the phase-2 clinical test plans (IND) on the 30th. |
All press releases naming this drug 16 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 34 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | enavogliflozin | “Enavogliflozin is a novel sodium-glucose cotransporter-2 inhibitor currently under clinical development.” PMID 36756676 ↗ Feb 202312“DWP16001 enavogliflozin (single oral dose) is administered in accordance with the study protocol.” NCT07213310 ↗ “Enavogliflozin (0.3mg oral tablet once daily) will be administrated.” NCT06350487 ↗ “The drug in this study is called enavogliflozin.” NCT06606093 ↗ “Enavogliflozin 0.3mg, once daily” NCT06644404 ↗ |
| Known as | DWP16001 | “DWP16001 0.3mg” NCT06606093 ↗ |
| Known as | Envlo tab | “SGLT2 inhibitor: Enavogliflozin (Brand names: Envlo tab)” NCT06350487 ↗ |
| Known as | ODP-9401 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3703921 ↗ |
| Action | Inhibit | “sodium-glucose cotransporter-2 inhibitor” PMID 36756676 ↗ Feb 2023 |
| Modality | Small molecule | — CHEMBL3703921 ↗ |
| Route | Oral | “orally” NCT03364985 ↗ |