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Details:
Jalra-Trio (vildagliptin + dapagliflozin + metformin) is a fixed dose combination medicine that helps control blood sugar levels. It is now approved for the treatment of type-2-diabetes mellitus.
Lead Product(s): Vildagliptin,Dapagliflozin,Metformin
Therapeutic Area: Endocrinology Product Name: Jalra Trio
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 11, 2023
Details:
DSR 2.0 (icodextrin, dextrose, dapagliflozin) is an implant small molecule drug combination, currently being investigated for heart failure management.
Lead Product(s): Icodextrin,Dextrose,Dapagliflozin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: DSR 2.0
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 29, 2023
Details:
Zibotentan/dapagliflozin combination leverages SGLT2 inhibition and high selectivity ETA receptor antagonism. It is being evaluated in phase 2 clinical trials for the treatment of chronic kidney disease and proteinuria.
Lead Product(s): Zibotentan,Dapagliflozin
Therapeutic Area: Nephrology Product Name: ZD4054
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 03, 2023
Details:
Zita DM contains the DPP4 inhibitor, Teneligliptin, the SGLT2 inhibitor, Dapagliflozin, and Metformin SR in a fixed dose. It must be taken once daily, under prescription, to improve glycemic control in patients with Type 2 diabetes.
Lead Product(s): Teneligliptin Hydrobromide,Dapagliflozin,Metformin
Therapeutic Area: Endocrinology Product Name: Zita DM
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 18, 2023
Details:
Forxiga (dapagliflozin) is an inhibitor of SGLT2. By inhibiting SGLT2, which is investigated for the treatment of children and adolescents with type 2 diabetes.
Lead Product(s): Dapagliflozin
Therapeutic Area: Endocrinology Product Name: Forxiga
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 04, 2023
Details:
Forxiga (dapagliflozin) is an inhibitor of SGLT2. By inhibiting SGLT2, it is indicated to reduce the risk of cardiovascular death, hospitalisation for HF, or urgent HF visits in adults with symptomatic chronic heart failure.
Lead Product(s): Dapagliflozin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Forxiga
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 18, 2023
Details:
Xigduo XR (dapagliflozin and metformin hydrochloride extended-release) tablet is a sodium-glucose cotransporter 2 inhibitor a once-daily fixed-dose combination, has been approved for type-2 diabetes.
Lead Product(s): Dapagliflozin,Metformin
Therapeutic Area: Endocrinology Product Name: Xigduo XR
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 27, 2023
Details:
Dapagliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, it reduces reabsorption of filtered glucose and thereby promotes urinary glucose excretion. It is approved by Health Canada for the treatment of type 2 diabetes.
Lead Product(s): Dapagliflozin
Therapeutic Area: Endocrinology Product Name: Forxiga-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 15, 2023
Details:
Farxiga (dapagliflozin), is first-in-class, oral, USFDA approved, once-daily SGLT2 inhibitor, which reduces reabsorption of filtered glucose and thereby promotes urinary glucose excretion. Thus, reducing the risk of cardiovascular death and hospitalisation for heart failure.
Lead Product(s): Dapagliflozin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Farxiga
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 09, 2023
Details:
Forxiga (dapagliflozin) is an inhibitor of SGLT2. By inhibiting SGLT2, dapagliflozin reduces reabsorption of filtered glucose and thereby promotes urinary glucose excretion
Lead Product(s): Dapagliflozin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Forxiga
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 07, 2023
Details:
Forxiga (dapagliflozin) is a first-in-class, oral, once-daily SGLT2 inhibitor. The CHMP recommendation states Forxiga is indicated in adults for the treatment of symptomatic chronic HF.
Lead Product(s): Dapagliflozin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Forxiga
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 19, 2022
Details:
Farxiga (dapagliflozin) is a first-in-class, oral, once-daily SGLT2 inhibitor. Farxiga is approved for adults and children aged 10 years and above for the treatment of insufficiently controlled T2D mellitus as an adjunct to diet and exercise.
Lead Product(s): Dapagliflozin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Farxiga
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 07, 2022
Details:
Zita D (teneligliptin) is a widely used DPP4i (Dipeptidyl Peptidase 4) inhibitor whereas Dapagliflozin is the most prescribed SGLT‐2i (Sodium glucose co‐transporter 2) inhibitor for diabetic patients in the country.
Lead Product(s): Teneligliptin Hydrobromide,Dapagliflozin
Therapeutic Area: Endocrinology Product Name: Zita D
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 20, 2022
Details:
Forxiga (dapagliflozin) also significantly reduced the relative risk of death from any cause by 31% (ARR=2.1%, p=0.0035) compared to placebo6. The safety and tolerability of Forxiga were consistent with the well-established safety profile of the medicine.
Lead Product(s): Dapagliflozin
Therapeutic Area: Nephrology Product Name: Forxiga
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 05, 2022
Details:
The analysis demonstrates Farxiga (dapagliflozin) ability to treat patients across the full left ventricular ejection fraction spectrum and reduce the risk of cardiovascular death.
Lead Product(s): Dapagliflozin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Farxiga
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 27, 2022
Details:
Research has shown Farxiga (dapagliflozin) efficacy in preventing and delaying cardiorenal disease, while also protecting the organs – important findings given the underlying links between the heart, kidneys and pancreas.
Lead Product(s): Dapagliflozin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Farxiga
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 27, 2022
Details:
GMRx4 is being developed to provide a synergistic effect from three best-in-class type 2 diabetes treatments – metformin, dapagliflozin and sitagliptin – and, in an ultra-low-dose, single pill formulation, aims to be a more effective, simpler and safer treatment regimen.
Lead Product(s): Metformin,Dapagliflozin,Sitagliptin Phosphate
Therapeutic Area: Endocrinology Product Name: GMRx4
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: CUREator
Deal Size: $1.0 million Upfront Cash: Undisclosed
Deal Type: Financing July 20, 2022
Details:
Interim results from ten evaluable patients after completion of intensive DSR 1.0 (alfapump DSR Therapy) period demonstrated that DSR therapy safely, effectively and rapidly eliminated persistent congestion and restored euvolemia, resulting in mean weight loss of 6kg.
Lead Product(s): Alfapump DSR Therapy,Dapagliflozin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: DSR 1.0
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 19, 2022
Details:
High-level results from DELIVER Phase III trial showed Farxiga (dapagliflozin) reached a statistically significant and clinically meaningful reduction in primary composite endpoint of cardiovascular death or worsening heart failure.
Lead Product(s): Dapagliflozin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Farxiga
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 05, 2022
Details:
Mankind Pharma has launched Justoza, a Dapagliflozin brand marketed by Mankind to treat diabetes, heart failure and chronic kidney disease. Launching API DMF grade dapagliflozin is an innovative futuristic approach to provide the best in class quality to the patients.
Lead Product(s): Dapagliflozin
Therapeutic Area: Endocrinology Product Name: Justoza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 22, 2021
Details:
Approval is based on DAPA-CKD Phase III trial in which FARXIGA demonstrated unprecedented reduction in the risk of the composite of worsening of renal function, end stage kidney disease and cardiovascular or renal death.
Lead Product(s): Dapagliflozin
Therapeutic Area: Nephrology Product Name: Farxiga
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Ono Pharmaceutical
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 30, 2021
Details:
Forxiga has been accepted for use within NHS Scotland by the Scottish Medicines Consortium (SMC) as an additional option for the treatment of symptomatic chronic heart failure with low ejection fraction in adults, as an add-on to already optimised standard care.
Lead Product(s): Dapagliflozin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Forxiga
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 14, 2021
Details:
The DARE-19 Phase III trial assessing the potential of Farxiga (dapagliflozin) to treat patients hospitalised with COVID-19 who are at risk of developing serious complications, did not achieve statistical significance for the primary endpoint.
Lead Product(s): Dapagliflozin
Therapeutic Area: Infections and Infectious Diseases Product Name: Farxiga
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Saint Luke's Health System
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 12, 2021
Details:
Forxiga is the first SGLT2 inhibitor approved in China for heart failure with reduced ejection fraction in adult patients with and without type-2 diabetes. Approval was based on positive results from the landmark DAPA-HF Phase III trial.
Lead Product(s): Dapagliflozin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Forxiga
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 04, 2021
Details:
DAPA-CKD Phase III trial showed that Farxiga, on top of standard of care consisting of an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker, reduced the risk of worsening renal function or risk of cardiovascular or renal death by 39%.
Lead Product(s): Dapagliflozin
Therapeutic Area: Nephrology Product Name: Farxiga
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 06, 2021
Details:
Forxiga is the first SGLT2 inhibitor approved in the EU for heart failure with reduced ejection fraction in adult patients with and without type-2 diabetes.
Lead Product(s): Dapagliflozin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Forxiga
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 05, 2020
Details:
Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated to improve glycemic control in adults with type 2 diabetes mellitus.
Lead Product(s): Dapagliflozin
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 29, 2020
Details:
China’s NMPA has updated the label for AstraZeneca’s Forxiga to include data from the DECLARE-TIMI 58 Phase III trial. This trial demonstrated that Forxiga reduced the risk of composite of hospitalisation for heart failure or cardiovascular death in type-2 diabetes.
Lead Product(s): Dapagliflozin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Farxiga
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 28, 2020
Details:
In the subgroup analysis, compared to placebo Farxiga showed a relative risk reduction of 37% for patients whose CKD was primarily driven by diabetic kidney disease; 57% for glomerulonephritis; and 42% for CKD of other or unknown causes.
Lead Product(s): Dapagliflozin
Therapeutic Area: Nephrology Product Name: Farxiga
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 23, 2020
Details:
Forxiga is the first SGLT2 inhibitor to have shown a statistically significant reduction in the risk of cardiovascular death or worsening of HF events versus placebo where both components of the primary composite endpoint contributed benefit to the overall effect.
Lead Product(s): Dapagliflozin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Farxiga
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 19, 2020
Details:
Designation follows DAPA-CKD Phase III trial results in which Farxiga demonstrated unprecedented reduction in the risk of kidney failure and cardiovascular or renal death in patients with chronic kidney disease.
Lead Product(s): Dapagliflozin
Therapeutic Area: Nephrology Product Name: Farxiga
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 02, 2020
Details:
Results from the ground-breaking Phase III DAPA-CKD trial showed that AstraZeneca’s Farxiga on top of standard of care reduced the composite measure of worsening of renal function or risk of cardiovascular (CV) or renal death by 39% compared to placebo in CKD patients.
Lead Product(s): Dapagliflozin
Therapeutic Area: Nephrology Product Name: Farxiga
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 30, 2020
Details:
Farxiga shows significant benefit across all primary and secondary endpoints in patients with chronic kidney disease with and without type-2 diabetes .
Lead Product(s): Dapagliflozin
Therapeutic Area: Nephrology Product Name: Farxiga
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 27, 2020
Details:
In previous Phase I and Phase IIa clinical trials in healthy subjects and in type 2 diabetics, the small molecule AMPK activator compound O304 was administered as a suspension and with limited oral bioavailability.
Lead Product(s): O304-Na,Dapagliflozin
Therapeutic Area: Endocrinology Product Name: O304-Na
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 17, 2020
Details:
FARXIGA significantly reduced the worsening of renal function or risk of death in patients with chronic kidney disease with and without type 2 diabetes.
Lead Product(s): Dapagliflozin
Therapeutic Area: Nephrology Product Name: Farxiga
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 28, 2020
Details:
The designation is based on the Phase III DAPA-MI trial that will explore the efficacy and safety of Farxiga in this patient population. Acute MI is a serious condition and a known cause of heart failure (HF). Approximately seven million heart attacks occur globally each year.
Lead Product(s): Dapagliflozin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Farxiga
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 16, 2020
Details:
EDP1815 will be included in the TACTIC-E clinical trial. The trial will evaluate the safety and efficacy of certain experimental therapies in the prevention and treatment of life-threatening complications associated with COVID-19 in hospitalized patients.
Lead Product(s): EDP1815,Ambrisentan,Dapagliflozin
Therapeutic Area: Infections and Infectious Diseases Product Name: EDP1815
Highest Development Status: Phase II/ Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 22, 2020
Details:
The newly launched trial, known as TACTIC-E (the “E” stands for “experimental”), has been designed to test drugs that have been specifically developed to treat Covid-19 as well as investigating whether combinations of drugs that are already in use can be effective.
Lead Product(s): Dapagliflozin,Ambrisentan
Therapeutic Area: Infections and Infectious Diseases Product Name: Forxiga
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 22, 2020
Details:
The SGLT2 inhibitor dapagliflozin, when used in patients with heart failure, provided a benefit in preventing type 2 diabetes (T2D).
Lead Product(s): Dapagliflozin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Farxiga
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2020
Details:
An oral presentation of data from the DAPA-HF trial showing the effect of Farxiga (dapagliflozin) on the incidence of new onset of type-2 diabetes (T2D) in patients with heart failure and reduced ejection fraction (HFrEF).
Lead Product(s): Dapagliflozin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Farxiga
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 11, 2020
Details:
The study will test whether its protective effects extend to COVID-19, the disease caused by the new coronavirus that can lead to heart and kidney complications.
Lead Product(s): Dapagliflozin
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 27, 2020
Details:
Trial will assess the potential Farxiga to reduce the risk of disease progression and death due to COVID-19 in patients who also have cardiovascular, metabolic or kidney risk factors.
Lead Product(s): Dapagliflozin
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 23, 2020
Details:
The decision was made following a routine assessment of efficacy and safety which showed Farxiga’s benefits earlier than originally anticipated and AstraZeneca will now initiate closure of the trial.
Lead Product(s): Dapagliflozin
Therapeutic Area: Nephrology Product Name: Farxiga
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 30, 2020
Details:
The sNDA was based on results from the landmark Phase III DAPA-HF trial, which showed FARXIGA reduced the incidence of the composite outcome of CV death or the worsening of HF versus placebo.
Lead Product(s): Dapagliflozin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 06, 2020
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