HOME > BUSINESS > Zydus Cadila starts Phase II trial on anemia drug for kidney patients

Zydus Cadila starts Phase II trial on anemia drug for kidney patients

Zydus said it started phase II trial on its anemia drug candidate ZYAN1.

The drug, a hypoxia-inducible factor prolyl hydroxylase inhibitor, is being tested as a treatment for anemia associated with chronic kidney disease (CKD).

The move follows successful Phase 1 trials. A drug has to go through three phases of clinical trials before it is submitted for approval.

Phase I trials of ZYAN1 were conducted in Australia and India, and results were recently published in Clinical Pharmacokinetics.

“ZYAN1 was safe and well-tolerated in healthy volunteers following single escalating oral doses (10-300 mg) and multiple escalating oral doses (100-300 mg).

The measurement of serum erythropoietin (EPO) levels in healthy volunteers confirmed the pharmacodynamic effect as EPO increased with increasing ZY AN1 doses in relation to placebo,” the company said.

The drug is supposed to inhibit hypoxia-inducible factor prolyl hydroxylase and thereby increase the natural production of hemoglobin and red blood cells in anemic patients.

ZYAN1 has been shown to improve iron mobilization and has the potential to reduce or eliminate the need for iron supplementation, the company said.

“We have observed desired pharmacokinetic & safety profile in addition to positive signals in biomarker responses, including erythropoietin increase with ZYAN1 in the two phase I trials that were conducted in Australia and India” said, Pankaj Patel, Chairman & Managing Director, Zydus Cadila.

“ZYANl has the potential to bring about a paradigm shift in the management of patients with anemia as it could provide an oral, safer alternative to currently available erythropoietin-stimulating agents (ESAs), which are associated with an increased risk of CV events, and must be given via injections. Zydus is committed to bring this therapy to millions of patients suffering from anemia,” he added.

Anemia is a global public health problem affecting both developing and developed countries. Anemia commonly arises in kidney disease patients, because the kidneys no longer produce sufficient amounts of erythropoietin, a hormone which stimulates red blood cell production.

Symptoms of anemia may include fatigue, skin pallor, shortness of breath, light-headedness, dizziness or a fast heartbeat. The Global ESA Market was estimated at USD 7 billion worldwide.

Follow ULTRA.news
Zydus Cadila gets USFDA nod to launch generic version of billion-dollar drug Cialis eventually The United States Food and Drug Administration has given Zydus Cadila approval to launch a generic version of the billion-dollar erectile dysfunction drug Cialis when patents expire.The patents are expected to expire in September next year.Cialis and Viagra are the most ...
Glenmark Pharma to launch birth control pill in USA Glenmark Pharmaceuticals said it got the approval of the United States Food & Drug Administration to launch a generic version of birth control pill Loestrin from Allergan Pharmaceuticals International.The drug had annual sales of approximately $116.8 million.The drug Nor...
Strides Shasun gets USFDA nod to launch nausea drug Strides Shasun Limited said it received approval from the United States Food & Drug Administration (USFDA) to launch a generic version of Diamox Tablets.The primary use of the Acetazolamide is to reduce nausea and dizziness associated with altitude sickness, but the drug is ...
After Lupin, Ajantha Pharma too launches generic ADHD drug in US A month after Lupin got it, Ajanta Pharma too said it got the approval to launch a generic version of Concordia Pharmaceuticals Inc.’s ADHD drug Kapvay.Lupin had got the nod in October, and said the drug had sales of around $66 mln in the US.Ajantha Pharma also said it ha...
Cipla gets US approval for cancer drug, Glenmark for oral contraceptive Two Indian pharmaceutical companies, Cipla and Glenmark, said they received approval from the US Food and Drug Administration for new drugs.While Cipla got the nod for a drug used to treat a type of blood cancer, Glenmark was approved to sell an oral contraceptive.Cipla...
Zydus gets nod for anti-inflammation drug in the US Pharma major Zydus Cadila said it received final approval from the USFDA to market an anti-inflammatory injection Ethacrynate Sodium in the US.The drug is used to decrease the Swelling (edema) caused by various disease conditions such as liver disease, kidney disease, conges...
Zydus Cadila has an excellent quarter in Q2, PAT up 33% Pharma giant Zydus Cadila reported excellent numbers for the September quarter, led by rising US revenue that lifted its margins and profits.For the second quarter ended September 30, 2017, Zydus Cadila reported Earnings before Interest, Depreciation and Tax (EBIDTA) of Rs. 8...
Zydus Cadila gets approval for cholesterol drug in Mexico Zydus Cadila said Mexico's drug regulator granted marketing approval to market its diabetes drug Lipaglyn in Mexico.The drug can be used to bring down cholesterol levels in patients even when conventional therapies like statins fail.“This approval of Saroglitazar in Mexi...
Biocon, Mylan apply again for EU approval for cancer drugs trastuzumab, pegfilgrastim Biocon said its partner Mylan has resubmitted the marketing application for two substances used to treat cancer -- trastuzumab and pegfilgrastim -- before European authorities after making changes to their production facilities.The drug applications before the European Medic...
Cipla gets USFDA nod to launch kidney drug in the US Pharma giant Cipla said it received final approval to market a generic version of Genzyme’s kidney drug Renvela Tablets in the US.Renvela Tablets had US sales of approximately $1.85 billion for the 12-month period ending August 2017, according to IMS Health.The approval...
Lupin gets USFDA approval for generic ADHD drug Pharma Major Lupin said it received final approval from the United States Food and Drug Administration (FDA) to market a generic version of Concordia Pharmaceuticals Inc.’s ADHD drug Kapvay.It had annual sales of approximately USD 66 million in the US.Clonidine Hydrochlo...
Lupin gets FDA nod to launch heart drug in the US Pharma manufacturer Lupin said it received approval to launch the generic version of US World Meds' Corgard heart drug.Nadolol Tablets USP, 20 mg, 40 mg, and 80 mg Tablets had annual sales of approximately USD 109.8 million in the US, the Indian drugmaker said.Lupin's N...
Zydus Cadila gets USFDA nod for overactive bladder drug Zydus Cadila said it received the final approval to launch overactive bladder drug Fesoterodine Fumarate in the US.The sales of Fesoterodine Fumarate Extended-Release Tablets are estimated at $195.5 million.It will be manufactured at the group’s formulations manufacturin...
NATCO Pharma to sell multiple sclerosis drug in USA via Mylan NATCO Pharma Limited said it the US Food and Drug Administration approved the generic drug application filed by its marketing partner Mylan for injections used in the treatment of multiple sclerosis, a chronic inflammatory disease of the central nervous system.The drug, Glat...
Glenmark Pharma gets USFDA approval for Desonide skin ointment Pharma giant Glenmark Pharmaceuticals said it received final approval to sell skin oinment Desonide Lotion in the US.The ointment has annual sales of approximately $23.2 million.The medicine is used to treat eczema, dermatitis, allergies, rashes etc.Desonide reduces...
Zydus Cadila gets approval for two drugs in the US Zydus Cadila said it received the final regulatory approval to market anti-sleep drug Modafinil in the US, and tentative approval for bladder control drug Solifenacin Succinate.Unlike a final approval, tentative approvals don't allow the grantee to sell the drugs in the US m...
Lupin gets nod to launch Metronidazole antibiotic in the US Lupin said it received final approval to market a generic version of G.D. Searle LLC Flagyl antibiotic tablets in the US.Flagyl tablets had US sales of USD 44.1 millionLupin’s Metronidazole Tablets USP, 250 mg and 500 mg are the AB rated generic equivalent of the drug. ...
Lupin gets UDFDA nod for generic version of Pfizer’s acne drug Pharma company Lupin said it received final approval from the US Food and Drug Administration for launching a generic version of Pfizer Inc.'s acne drug Vibra-Tabs.Doxycycline Hyclate Tablet 100 mg had US sales of USD 149.9 million per year, the company said.Doxycycline ...
Panacea Biotec to supply heart drug to Apotex for US market Pharma company Panacea Biotec said it has signed an agreement to supply a generic version of Eli Lilly's Effient heart drug to Apotex, the largest Canadian-owned pharmaceutical company.The drug will be sold by Apotex in the US market."Under the terms of the agreement, Ap...
Zydus Cadila to launch immuno-suppressant in the US Pharma giant Zydus Cadila said it received final approval from the USFDA to market immunonsuppressant Mycophenolate Mofetil injection.The drug is indicated for use in combination with other drugs i.e., cyclosporine and corticosteroids for the prophylaxis of organ rejection ...