Evaluate the Efficacy and Safety of the Combined Use of a Sodium-glucose Cotransporter 2 (iSGLT2) Inhibitor and a Dipeptidyl Peptidase-4 (iDPP -4) Inhibitor in the Treatment of Type 2 Diabetes Mellitus in Patients Treated With Metformin

The present study aims to evaluate the efficacy and safety of different combinations of oral antidiabetics in patients with inadequate glycemic control on metformin monotherapy.

Start Date30 Nov 2026

Sponsor / Collaborator

Eurofarma Laboratórios SA

TCTR20241220001

/ Not yet recruitingPhase 1IIT

An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover oral bioequivalence study of Dapagliflozin Tablets 10 mg in healthy adult human subjects under fasted conditions

Start Date06 May 2025

Sponsor / Collaborator

Bio-innova Co., Ltd

TCTR20250102004

/ Not yet recruitingPhase 1

A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Dapagliflozin 10 mg Film-coated Tablets (Dapagliflozin 10 mg FCT) and Reference Product (FORXIGA (10 MG FILM - COATED TABLETS)) in Healthy Thai Volunteers under Fasting Conditions

Start Date05 May 2025

Sponsor / Collaborator-

100 Clinical Results associated with Dapagliflozin

100 Translational Medicine associated with Dapagliflozin

100 Patents (Medical) associated with Dapagliflozin

4,330

Literatures (Medical) associated with Dapagliflozin

31 Dec 2025·GYNECOLOGICAL ENDOCRINOLOGY

Animal experiments and network pharmacology to explore the anti-inflammatory mechanism of dapagliflozin in the treatment of polycystic ovary syndrome

Article

Author: Zhang, Zhen ; Bai, He ; Liu, Yong ; Li, Luxin ; Song, Xueqing ; Guan, Huilin ; Yong, Zihao ; Guo, Xiaomeng ; Wang, Chunhua

BACKGROUND:

Polycystic ovary syndrome (PCOS) is a common endocrine and metabolic disorder associated with chronic low-grade inflammation of the ovary. Sodium glucose co-transporter 2 (SGLT2) inhibitors are a class of antidiabetic drugs that can reduce the weight and hyperglycemia of type 2 diabetes patients. Dapagliflozin is a highly selective, orally active and reversible inhibitor of the human SGLT2. However, the role of dapagliflozin in regulating PCOS remains unclear.

METHODS:

In this study, 24 six-week-old female Sprague Dawley (SD) rats were randomly divided into control, letrozole, and letrozole + dapagliflozin groups. PCOS model rats were produced by gavage administration of letrozole for 21 days. The intervention was conducted after the gavage administration of dapagliflozin for 14 days to evaluate the estrous cycle and ovarian imaging changes of the rats in each group. We observed changes in the weight, ovarian weight, and ovarian morphology of the rats in each group. Pathological changes in the ovaries were examined by H&E staining, changes in ovarian tissue cell apoptosis were identified using TdT-mediated dUTP Nick-End Labeling (TUNEL) staining, and changes in inflammation-related factors were detected using immunohistochemistry and Western blotting analysis. Network pharmacology was used to predict the inflammatory targets and pathways affected by dapagliflozin in treating PCOS, and the potential interactions between dapagliflozin and inflammation-related target proteins were evaluated through molecular docking.

RESULTS:

Our results demonstrated that dapagliflozin treatment significantly improved PCOS symptoms, recovered ovarian morphology and physiological functions, and reduced the apoptosis of ovarian cells after drug intervention. Dapagliflozin treatment also reduced the levels of pro-inflammatory cytokines such as IL-1β, IL-6, and TNF-α, indicating its anti-inflammatory properties. Furthermore, network pharmacology identified 26 intersecting target genes relevant to inflammation in PCOS, with subsequent molecular docking simulations revealing strong binding affinities of dapagliflozin to key targets, including AKT1 and TP53.

CONCLUSIONS:

These findings suggest that dapagliflozin exerts beneficial effects on PCOS by ameliorating ovarian dysfunction and reducing inflammation. Dapagliflozin represents a promising therapeutic candidate for managing PCOS, warranting further clinical investigation to explore its full potential in treating this multifaceted disorder.

31 Dec 2025·RENAL FAILURE

Dapagliflozin improves diabetic kidney disease by inhibiting ferroptosis through β-hydroxybutyrate production

Article

Author: Feng, Bo ; Song, Jun ; Li, Ziyi ; Zhou, Chenxia ; Yan, Qun ; Tian, Yan ; Chen, Da

BACKGROUND:

Diabetic kidney disease (DKD) is the leading cause of end-stage renal disease. Sodium-glucose cotransporter protein 2 inhibitors (SGLT2i) are antihyperglycemic agents that provide additional renal-protective effects in patients with DKD, independent of their glucose-lowering effects. However, the underlying mechanism remains unclear. This study hypothesized that SGLT2i could alleviate diabetic kidney injury by inhibiting ferroptosis and explored its potential mechanisms.

METHODS:

C57BL/6J mice were randomly divided into the control, DKD, DKD+dapagliflozin, and DKD+insulin treatment groups. Blood glucose levels and body weight were monitored. Renal function, tissue pathology, mitochondrial morphology and function, and lipid peroxidation biomarkers (lipid peroxidation [LPO], malondialdehyde [MDA], glutathione peroxidase 4 [GPX4], glutathione [GSH], and cystine transporter solute carrier family 7 member 11 [SLC7A11]) were evaluated. Human proximal tubule cells (HK2 cells) were exposed to high glucose alone or in combination with dapagliflozin. The mitochondrial membrane potential (MMP), adenosine triphosphate (ATP) level, NAD+/NADH ratio (oxidized/reduced ratio of nicotinamide adenine dinucleotide), and lipid peroxidation were measured. In addition, the role of the β-hydroxybutyrate- Calcium/Calmodulin Dependent Protein Kinase Kinase 2 (BHB-CaMKK2) axis in mediating dapagliflozin regulating ferroptosis was examined.

RESULTS:

Dapagliflozin significantly ameliorated kidney injury in mice with DKD. Typical changes in ferroptosis, including lipid peroxidation and impaired antioxidant capacity, increased in mice with DKD and HG-treated HK-2 cells. Dapagliflozin significantly improves ferroptosis-related lipid peroxidation and mitochondrial dysfunction. Furthermore, dapagliflozin suppressed the expression of CaMKK2, a key ferroptosis regulator. Specific CaMKK2 inhibitors alleviated mitochondrial damage and ferroptosis, whereas a CaMKK2 agonist counteracted the protective effects of dapagliflozin against mitochondrial, antioxidant, and anti-ferroptosis effects. In addition, dapagliflozin increased BHB production, which mediates its nephroprotective effects.

CONCLUSION:

Dapagliflozin improves DKD by inhibiting ferroptosis, promoting BHB production, and regulating CaMKK2.

01 Dec 2025·MOLECULAR BIOLOGY REPORTS

Protective effect of dapagliflozin on lipopolysaccharide-induced acute lung injury via the SIRT-1/PGC-1α pathway

Article

Author: Ozmen, Ozlem ; Zeynalov, Toghrul ; Savran, Mehtap ; Arlioglu, Melih ; Ozcan, Mustafa Soner ; Ilhan, Ilter ; Camas, Hasan Ekrem ; Akin, Suleyman Emre

BACKGROUND:

Acute systemic inflammation affects many organs and it occurs in a wide range of conditions such as acute lung injury (ALI). Inflammation-triggered oxidative pathways together with the caspase activation seen in ALI, result in apoptosis. Dapagliflozin (DPG) is an agent that is known to have oxidative stress-reducing and anti-inflammatory effects in many tissues.

METHODS AND RESULTS:

Thirty-two Wistar albino rats were divided into four groups: control, lipopolysaccharide (LPS) (5 mg/kg), LPS + DPG (10 mg/kg) and DPG. DPG was orally administered for five consecutive days LPS was intraperitoneally applied in a single dose on the fifth day and the animals were euthanized six hours after the last drug administration. Lung tissues were harvested. In addition to hematoxylin-eosin staining, caspase-3 (Cas-3) and tumor necrosis factor alpha (TNF-α) immunostainings were conducted. While total oxidant status (TOS), total antioxidant status (TAS), and oxidative stress index (OSI) were examined biochemically, Sirtuin-1 (SIRT-1), Peroxisome proliferator-activated receptor-gamma coactivator 1-alpha (PGC-1α), B-cell lymphoma 2 (Bcl-2), and Bcl-2 associated X protein (Bax) were examined by PCR. Histopathological analysis revealed hyperemia, edema, inflammatory cell infiltration, and epithelial cell loss. In LPS group, Cas-3, TNF-α, TOS, OSI, and Bax values increased whereas SIRT-1, PGC-1α, and Bcl-2 values decreased. All these changes were restored with DPG treatment.

CONCLUSION:

DPG exhibited protective effects against inflammation, oxidative stress, and subsequent apoptosis observed in systemic inflammation-induced ALI likely through SIRT-1/ PGC-1α pathway.

194

News (Medical) associated with Dapagliflozin

06 Feb 2025

·www.businesswire.com

AstraZeneca’s Full Year and Q4 2024 results

CAMBRIDGE, England--( BUSINESS WIRE )--AstraZeneca: Revenue and EPS summary FY 2024 % Change Q4 2024 % Change $m Actual CER i $m Actual CER - Product Sales 50,938 16 19 13,362 18 19 - Alliance Revenue 2,212 55 55 714 68 69 - Collaboration Revenue 923 56 54 815 >2x >2x Total Revenue 54,073 18 21 14,891 24 25 Reported EPS $4.54 18 29 $0.97 56 71 Core ii EPS $8.21 13 19 $2.09 44 49 Financial performance for FY 2024 (Growth numbers at constant exchange rates) Total Revenue up 21% to $54,073m, driven by a 19% increase in Product Sales, continued growth of partnered medicines (Alliance Revenue) and the achievement of sales-based milestones (Collaboration Revenue) Total Revenue growth from Oncology was 24%, CVRM 20%, R&I 25%, V&I 8% and Rare Disease 16% Core EPS increased 19% to $8.21 Second interim dividend declared of $2.10 per share, making a total annual dividend declared for FY 2024 of $3.10 per share, an increase of 7%. Dividend to be further increased in FY 2025 Guidance for FY 2025: Total Revenue is expected to increase by a high single-digit percentage and Core EPS is expected to increase by a low double-digit percentage, both at CER Pascal Soriot, Chief Executive Officer, AstraZeneca, said: “ Our company delivered a very strong performance in 2024 with Total Revenue and Core EPS up 21% and 19% respectively. We also delivered nine positive high value Phase III studies in the year, which coupled with increasing demand for our medicines in all key regions, will help sustain our growth momentum into 2025. This year marks the beginning of an unprecedented, catalyst-rich period for our company, an important step on our Ambition 2030 journey to deliver $80 billion Total Revenue by the end of the decade. In 2025 alone, we anticipate the first Phase III data for seven new medicines, along with several important new indication opportunities for our existing medicines. We are also investing in and making significant progress with transformative technologies that have the potential to drive our growth well beyond 2030, many of which have now entered pivotal trials.” Key milestones achieved since the prior results announcement Positive read-outs for Truqap in combination with abiraterone and androgen deprivation therapy in PTEN -deficient de novo metastatic hormone-sensitive prostate cancer (CAPItello-281) and Tagrisso with or without chemotherapy in resectable early-stage EGFR m NSCLC (NeoADAURA) US approvals for Imfinzi in limited-stage small cell lung cancer (ADRIATIC), Calquence in combination with bendamustine and rituximab in mantle cell lymphoma (ECHO), Datroway (datopotamab deruxtecan) in HR+ HER2- metastatic breast cancer (TROPION-Breast01) and Enhertu in chemotherapy-naïve HER2-low and -ultralow metastatic breast cancer (DESTINY-Breast06). EU approvals for Tagrisso in unresectable EGFR m NSCLC (LAURA) and Kavigale for prevention of COVID-19 (SUPERNOVA). Japan approvals for Imfinzi in endometrial cancer (DUO-E), Lynparza plus Imfinzi in pMMR endometrial cancer (DUO-E), Calquence tablet formulation in chronic / small lymphocytic leukaemia, Datroway in HR+ HER2- metastatic breast cancer, Fasenra in EGPA (MANDARA) and Kavigale for prevention of COVID-19. China approvals for Lynparza in gBRCAm HER2- early breast cancer (OlympiA), Orpathys in locally advanced or metastatic MET Exon 14 NSCLC (NCT04923945) Guidance The Company issues its Total Revenue and Core EPS guidance for FY 2025 at CER, based on the average foreign exchange rates through 2024. Total Revenue is expected to increase by a high single-digit percentage Core EPS is expected to increase by a low double-digit percentage The Core Tax rate is expected to be between 18-22% The Company is unable to provide guidance on a Reported basis because it cannot reliably forecast material elements of the Reported results, including any fair value adjustments arising on acquisition-related liabilities, intangible asset impairment charges and legal settlement provisions. Please refer to the cautionary statements section regarding forward-looking statements at the end of this announcement. Currency impact If foreign exchange rates for February 2025 to December 2025 were to remain at the average rates seen in January 2025, it is anticipated that Total Revenue in FY 2025 would incur a low single-digit percentage adverse impact compared to the performance at CER, and Core EPS would incur a mid-single-digit percentage adverse impact. The Company’s foreign exchange rate sensitivity analysis is provided in Table 17. Capital allocation In FY 2025, the Company intends to increase the annual dividend declared to $3.20 per share. The Company also expects to increase capital expenditure iii by approximately 50%, driven by manufacturing expansion projects and investment in IT systems, to support portfolio growth and build capacity for transformative technologies. China In relation to the illegal drug importation allegations, in January 2025, AstraZeneca received a Notice of Transfer to the Prosecutor and an Appraisal Opinion from the Shenzhen City Customs Office regarding suspected unpaid importation taxes amounting to $0.9 million. To the best of AstraZeneca’s knowledge, the importation taxes referred to in the Appraisal Opinion relate to Imfinzi and Imjudo . A fine of between one and five times the amount of unpaid importation taxes may also be levied if AstraZeneca is found liable. AstraZeneca continues to fully cooperate with the Chinese authorities. In December 2024 AstraZeneca announced the appointment of Iskra Reic as Executive Vice President, International, which encompasses China, Asian and Eurasian markets, Middle East & Africa, Latin America, Australia & New Zealand. Iskra succeeds Leon Wang who is on extended leave from the Company while under investigation in China. Table 1: Key elements of Total Revenue performance in Q4 2024 % Change Revenue type $m Actual % CER % Product Sales 13,362 18 19 Alliance Revenue 714 68 69 $392m Enhertu (Q4 2023: $281m) $133m Tezspire (Q4 2023: $80m) $161m Beyfortus (Q4 2023: $41m) Collaboration Revenue 815 >2x >2x $600m Lynparza (Q4 2023: $245m) $111m Beyfortus (Q4 2023: $27m) $100m Koselugo (Q4 2023: nil) Total Revenue 14,891 24 25 Therapy areas $m Actual % CER % Oncology 6,344 27 29 Tagrisso up 20% (21% at CER), Calquence up 20%, Enhertu up 48% (54% at CER) CVRM 3,138 16 17 Farxiga up 21% (22% at CER) , Lokelma up 35% R&I 2,127 27 28 Breztri up 29%. Saphnelo up 65%, Tezspire up 86% (85% at CER), Symbicort up 31% (33% CER) V&I 651 58 55 Beyfortus Total Revenue up >3x Rare Disease 2,377 21 22 Ultomiris up 32% (33% at CER), partially offset by decline in Soliris of 24% (22% at CER), Strensiq up 38% (37% at CER) and Koselugo up >3x Other Medicines 254 (7) (6) Total Revenue 14,891 24 25 Regions $m Actual % CER % US 6,532 28 28 Product Sales up 25% Emerging Markets 3,134 13 19 - China 1,364 (1) (3) Decline primarily due to low rates of seasonal respiratory viral infections, and impact from year-end hospital budget dynamics - Ex-China Emerging Markets 1,770 26 42 Europe 3,948 37 35 Product Sales up 20% (18% at CER) Established RoW 1,277 1 2 Total Revenue 14,891 24 25 Key alliance medicines Combined sales of Enhertu , recorded by Daiichi Sankyo Company Limited (Daiichi Sankyo) and AstraZeneca, amounted to $3,754m in FY 2024 (FY 2023: $2,566m) Combined sales of Tezspire , recorded by Amgen and AstraZeneca, amounted to $1,219m in FY 2024 (FY 2023: $653m) Table 2: Key elements of financial performance in Q4 2024 Metric Reported Reported change Core Core change Comments iv Total Revenue $14,891m 24% Actual 25% CER $14,891m 24% Actual 25% CER See Table 1 and the Total Revenue section of this document for further details Product Sales Gross Margin 80% Stable Actual +1pp CER 79% -1pp Actual Stable CER Variations in Product Sales Gross Margin can be expected between periods, due to product seasonality, foreign exchange fluctuations and other effects R&D expense $4,677m 52% Actual 52% CER $3,573m 23% Actual 22% CER Increased investment in the pipeline Core R&D-to-Total Revenue ratio of 24% (Q4 2023: 24%) Reported R&D includes $753m impairment recorded against the vemircopan (ALXN2050) intangible asset SG&A expense $5,410m 1% Actual 1% CER $4,275m 6% Actual 7% CER Market development for recent launches and pre-launch activities Core SG&A-to-Total Revenue ratio of 29% (Q4 2023: 34%) Other operating income and expense v $100m -7% Actual -6% CER $101m -7% Actual -6% CER Operating Margin 14% +3pp Actual +4pp CER 28% +5pp Actual +6pp CER See commentary above on Gross Margin, R&D, SG&A and Other operating income and expense Net finance expense $365m 9% Actual 8% CER $310m 20% Actual 20% CER Recent debt issued at higher interest rates Decrease in interest income Higher level of Net debt Tax rate 10% +17pp Actual +15pp CER 16% +7pp Actual +7pp CER Variations in the tax rate can be expected between periods EPS $0.97 56% Actual 71% CER $2.09 44% Actual 49% CER Further details of differences between Reported and Core are shown in Table 12 Table 3: Pipeline highlights since prior results announcement Event Medicine Indication / Trial Event Regulatory approvals and other regulatory actions Tagrisso EGFR m NSCLC (Stage III unresectable) (LAURA) Regulatory approval (EU, CN) Imfinzi Limited-stage SCLC (ADRIATIC) Regulatory approval (EU) Imfinzi Advanced endometrial cancer Regulatory approval (JP) Calquence Tablets for chronic lymphocytic leukaemia Regulatory approval (JP) Calquence Mantle cell lymphoma (1st-line) (ECHO) Regulatory approval (US) Lynparza + Imfinzi Advanced endometrial cancer with mismatch repair proficiency (DUO-E) Regulatory approval (JP) Lynparza gBRCAm HER2- eBC (OlympiA) Regulatory approval (CN) Enhertu HR+ HER2-low and -ultralow mBC (DESTINY-Breast06) Regulatory approval (US) Datroway HR+ HER2- mBC (TROPION-Breast01) Regulatory approval (JP, US) Orpathys MET exon 14 skipping altered NSCLC (NCT04923945) Regulatory approval (CN) Fasenra EGPA (MANDARA) Regulatory approval (JP) Kavigale Prevention of COVID-19 (SUPERNOVA) Regulatory approval (EU, JP) Regulatory submissions or acceptances* Imfinzi Muscle-invasive bladder cancer (NIAGARA) Regulatory submission (US, JP) Imfinzi + Imjudo NSCLC (1st-line) (POSEIDON) Regulatory submission (CN) Calquence Chronic lymphocytic leukaemia (1st-line) (AMPLIFY) Regulatory submission (EU) Datroway EGFR m NSCLC (later line) (TROPION-Lung05) Regulatory submission (US) Tezspire Severe uncontrolled asthma (NAVIGATOR/ DIRECTION) Regulatory submission (CN) Koselugo Neurofibromatosis type 1 adult (KOMET) Regulatory submission (EU, JP) Phase III / registrational data readouts and other developments Tagrisso Resectable early-stage EGFR m NSCLC (NeoADAURA) Primary endpoint met Truqap PTEN -deficient de novo metastatic hormone-sensitive prostate cancer (CAPItello-281) Primary endpoint met *US, EU and China regulatory submission denotes filing acceptance Other pipeline updates In January 2025, the vemircopan (ALXN2050) Phase II development programme was terminated. The decision was based on safety and efficacy data from Phase II trials. Upcoming pipeline catalysts For recent trial starts and anticipated timings of key trial readouts, please refer to the Clinical Trials Appendix, available on www.astrazeneca.com/investor-relations.html . Sustainability highlights The Company convened an event on health equity for investors and analysts in November that detailed AstraZeneca’s health equity strategy, which is embedded from the Company’s science through to healthcare delivery and community engagement. At the end of 2024, the Company’s cumulative reduction in Scope 1 and 2 greenhouse gas (GHG) emissions was 77.5% from the 2015 baseline. Conference call A conference call and webcast for investors and analysts will begin today, 6 February 2025, at 11:00 UK time. Details can be accessed via astrazeneca.com . Reporting calendar The Company intends to publish its Q1 2025 results on 29 April 2025. To read AstraZeneca's Full Year and Q4 2024 Financial Results press release in full, click here .

Phase 2Financial StatementExecutive ChangeDrug ApprovalPhase 3

27 Jan 2025

·www.drugs.com

Diabetes Remission Increased With Dapagliflozin Plus Calorie Restriction

MONDAY, Jan. 27, 2025 -- For patients with overweight or obesity and type 2 diabetes, dapagliflozin plus regular calorie restriction is associated with a significantly higher rate of remission of diabetes compared with calorie restriction alone, according to a study published online Jan. 22 in The BMJ . Yuejun Liu, from Fudan University in Shanghai, and colleagues conducted a multicenter, double-blind randomized trial in 16 centers in China from June 12, 2020, to Jan. 31, 2023, involving 328 patients with type 2 diabetes aged 20 to 70 years, with body mass index >25 kg/m 2 and diabetes duration of less than six years. Patients were randomly assigned to calorie restriction with dapagliflozin 10 mg/day or placebo. The researchers found that diabetes remission was achieved in 44 and 28 percent of patients in the dapagliflozin and placebo groups, respectively, over 12 months (risk ratio, 1.56), meeting the predefined primary end point. Significantly greater changes in body weight (difference, −1.3 kg) and homoeostasis model assessment of insulin resistance (difference, −0.8) were seen in the dapagliflozin versus placebo group. Likewise, compared with the placebo group, significantly more improvement was seen in body fat, systolic blood pressure, and metabolic risk factors in the dapagliflozin group. The occurrence of adverse events did not differ between the groups. "Our findings provide an alternative and more practical strategy than intensive weight management to achieve remission for patients with early type 2 diabetes," the authors write. The study was partially funded by AstraZeneca, the manufacturer of dapagliflozin. Abstract/Full Text Editorial Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical ResultClinical Study

23 Jan 2025

·endpts.com

Teva, Astellas plan to participate in IRA drug price negotiations

At least three drugmakers say they will participate in the next round of Medicare negotiations under the Inflation Reduction Act, even though they continue to criticize the process as “price setting.” Teva, Astellas and AstraZeneca confirmed to Endpoints News that they will negotiate the prices of the movement disorder drug Austedo, and cancer drugs Xtandi and Calquence, respectively. AstraZeneca had participated in the first cycle of negotiations with its diabetes drug Farxiga. The government last Friday selected 15 medicines that will be subject to negotiations in the next cycle. Under the current guidance , drugmakers have until the end of February to decide if they will participate. GSK, which has inhaler products on the list, said it’s “assessing all possible paths forward.” Novo Nordisk, which has blockbuster diabetes and weight loss products on the list, also said it will “explore all options.” Other companies did not respond to requests for comment A spokesperson for Teva told Endpoints that the company is “confident in our ability to navigate the impact of the IRA,” despite the selection of its movement disorder treatment Austedo and its extended-release version, Austedo XR. The company said last summer that it had already factored the IRA into its business plan. “While some assumptions and market dynamics have shifted, and are still evolving, we will continue to experience strong growth based on our current analysis,” the spokesperson said on Thursday. Teva is challenging the IRA’s implementation in a lawsuit filed before CMS selected the next 15 drugs for negotiation. When asked if the company plans to update its lawsuit based on Austedo’s selection, the spokesperson said it “stands as filed.” AstraZeneca is one of six drugmakers being asked to return to the negotiating table this year after participating in the first round. David Fredrickson, executive VP of AstraZeneca’s oncology business unit, said on Wednesday that CMS made a mistake in determining Calquence’s eligibility. Some participants in the first round of negotiations argued that they were left with no choice but to cooperate, as opting out could lead to hefty fines or pulling out of Medicare and Medicaid altogether. “The drug selection process does not address Austedo and Austedo XR’s meaningful clinical value to patients,” the Teva spokesperson said. Astellas said the “price-setting policies” under the negotiation program “are not in the best interest of patients.” Editor’s Note: This story has been updated with additional comment from Novo Nordisk.

100 Deals associated with Dapagliflozin

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KEGG	Wiki	ATC	Drug Bank
D09763	Dapagliflozin	A10BK01	DB06292

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 1	JP	AstraZeneca Pharmaceuticals Co. Ltd.	26 Mar 2019
Chronic heart failure	EU	AstraZeneca AB	11 Nov 2012
Chronic heart failure	IS	AstraZeneca AB	11 Nov 2012
Chronic heart failure	LI	AstraZeneca AB	11 Nov 2012
Chronic heart failure	NO	AstraZeneca AB	11 Nov 2012
Chronic Kidney Diseases	AU	AstraZeneca Pty Ltd.	22 Oct 2012
Diabetes Mellitus, Type 2	AU	AstraZeneca Pty Ltd.	22 Oct 2012
Heart Failure	AU	AstraZeneca Pty Ltd.	22 Oct 2012

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute myocardial infarction	Phase 3	SE	AstraZeneca PLC	22 Dec 2020
Acute myocardial infarction	Phase 3	GB	AstraZeneca PLC	22 Dec 2020
COVID-19	Phase 3	US	AstraZeneca PLC	22 Apr 2020
COVID-19	Phase 3	AR	AstraZeneca PLC	22 Apr 2020
COVID-19	Phase 3	BR	AstraZeneca PLC	22 Apr 2020
COVID-19	Phase 3	CA	AstraZeneca PLC	22 Apr 2020
COVID-19	Phase 3	IN	AstraZeneca PLC	22 Apr 2020
COVID-19	Phase 3	MX	AstraZeneca PLC	22 Apr 2020
COVID-19	Phase 3	GB	AstraZeneca PLC	22 Apr 2020
Respiratory Failure	Phase 3	US	AstraZeneca PLC	22 Apr 2020

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04004793 (Pubmed) Manual	Phase 4	Diabetes Mellitus, Type 2	328	Dapagliflozin 10 mg/day	mvjbhrxwhl(pcuvpyylue) = xzlyinxnsp efvrkxjzsx (bneyiegkql ) Met	Positive	22 Jan 2025
				Placebo	mvjbhrxwhl(pcuvpyylue) = nhlerkqfcx efvrkxjzsx (bneyiegkql ) Met
NCT03036150 (DAPA-CKD, Pubmed \| Clin J Am Soc Nephrol)	Phase 3	Chronic Kidney Diseases type 2 diabetes	4,304	Dapagliflozin 10mg	ddwzssxnqh(nregmkyavr) = ekdrrgflqe ptukyyhftr (eywzxdylpx, 30.2% - 42.5%)	Positive	01 Dec 2024
				Placebo	ddwzssxnqh(nregmkyavr) = ahwxkvyuml ptukyyhftr (eywzxdylpx, 12 - 30%)
NCT04595370 (MIRACLE, CTgov)	Phase 2	Heart Failure \| Chronic Kidney Diseases	153	Dapagliflozin	sgjorempfg(efajhxgfoh) = xhivisuhmi bvgjqxoknu (mvgflhcvbw, fwyjrbjnnt - wrtalwtulf) View more	-	19 Nov 2024
NCT04445714 (CTgov)	Phase 4	Diabetes Mellitus, Type 2	196	Saxagliptin+Dapagliflozin	ymeuwbykmm(qecyjhxnvr) = xfuhadshwk whsroehcud (cmsqungxcx, kmjssuhfnx - qvybjidjql) View more	-	12 Nov 2024
NCT03030235 \| NCT02653482 (DEFINE-HF;PRESERVED-HF, Pubmed \| Circ Heart Fail)	Phase 3	Heart Failure ketone \| fatty acid \| 3-hydroxybutyrate	527	Dapagliflozin	wdknkaodum(eyqnnmgjmb) = noktovtixd ihbdzkjjzh (fthkaspbid )	Positive	01 Nov 2024
				Placebo	wdknkaodum(eyqnnmgjmb) = xdnsgcybvu ihbdzkjjzh (fthkaspbid )
NCT05014594 (Pubmed \| Dig Dis Sci) Manual	Phase 2	Ascites	40	Dapagliflozin 10 mg/day	ljlfvmugrh(jlbgssabpv): P-Value = 0.04 View more	Negative	09 Oct 2024
				Placebo
EANM2024	Not Applicable	Cardiotoxicity	37	Dapagliflozin	jlthptdmxo(bvbiwlyusa) = twpywjdzdi lhancuzyzt (rkjhlctzaj, 220.88) View more	Positive	27 Sep 2024
				Placebo	jlthptdmxo(bvbiwlyusa) = naxbkeyrsi lhancuzyzt (rkjhlctzaj, 277.92) View more
ESC2024	Not Applicable	Myocardial Infarction	-	Dapagliflozin 10 mg	yjpioujnwt(tkwhgkwvvn) = dowepzupsl mntoxpzmww (okfjkdgwws ) View more	-	02 Sep 2024
				Placebo	yjpioujnwt(tkwhgkwvvn) = vdxezscbsi mntoxpzmww (okfjkdgwws ) View more
NCT02397421 (REFORM, ESC2024)	Phase 4	Diabetes Mellitus, Type 2 \| Heart failure with reduced ejection fraction	47	Dapagliflozin	qdjdqwnbin(pkzcbaleud) = ebencjbfes othqkcwfwi (npwenhfqbm )	Positive	01 Sep 2024
				Placebo	qdjdqwnbin(pkzcbaleud) = qyjaqihorm othqkcwfwi (npwenhfqbm )
NCT01730534 (DECLARE-TIMI 58, ESC2024)	Phase 3	Neoplasms LVEF \| GLS \| E/A ratio ... View more	32	Dapagliflozin	pxhzajcfop(aagerxoows) = sltjvxpjjz jowiqzmdns (ovpammqhlm, 2.8) View more	Positive	01 Sep 2024
				Placebo	pxhzajcfop(aagerxoows) = hooweidwgu jowiqzmdns (ovpammqhlm, 2.1) View more

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Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Dapagliflozin

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation