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New Drug For Kidney Disease 2022 - FDA Approved New Medication for HRS

Kidney failure happens due to many other diseases. One such deadly disease is hepatorenal syndrome. This liver disease worsens kidney functions at a rapid rate. Terlipressin, sold under the brand name Terlivaz, became the world’s first FDA-approved drug to improve kidney function in adults with HRS. Read to the end to know more about the new kidney disease drug in detail.

  • Nephrologyy

By Aranya Doloi

13th Oct '22

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Kidney diseases often occur due to other underlying conditions. Diabetes is the most common cause of kidney failure. Likewise, hepatorenal syndrome (HRS) is a life-threatening liver disease that affects your kidney function. Creatinine levels rise in people with advanced cirrhosis (liver scarring) and ascites. Ascites is a liver-related condition when abnormal fluid builds up in the abdomen.  

According to Kash Yap, a general practitioner with a year of experience in the Dialysis Unit,

"The exact mechanisms of HRS are still unknown. The working theory is that liver scarring (cirrhosis) affects the blood circulation causing low blood flow to the kidneys."


“The kidneys contain these clumps of capillaries (glomerulus) which filter blood and are highly reliant on the blood flowing through it. With low blood circulation, glomerular filtration rate decreases. This can happen rapidly or slowly.”

During HRS, kidney functions have a poor prognosis. In most cases, liver transplantation is required to decrease kidney function worsening. Until 2022, there were no approved kidney medications for this condition. 

However, a breakthrough innovation buzzed the medical sector this year. , sold under the brand name Terlivaz, became the world’s first FDA-approved drug to improve kidney function in adults with HRS. 

Things to know about terlipressin (Terlivaz)

The US Food and Drug Administration (FDA) approved the terlipressin (Terlivaz) injection in September 2022. It is the first FDA-approved kidney medicine to indicate improvement in renal function. The injection is only meant for adults with a rapid reduction in kidney function due to HRS. However, a study showed that patients with serum creatinine levels of 5 mg/dL or more are unlikely to benefit from terlipressin. 

The FDA has approved terlipressin (Terlivaz) injection to improve kidney function in adults suffering from hepatorenal syndrome (HRS). Terlipressin treatment is only for those patients whose HRS has led to a rapid reduction in kidney function. Terlipressin, sold under the brand name Terlivaz by Mallinckrodt Pharmaceuticals, is the first medication approved by FDA for this condition.

Mallinckrodt Pharmaceuticals, an American-Irish manufacturer of specialty pharmaceuticals, received approval from the FDA. The FDA’s approval is based on phase 3 CONFIRM trial results. The trial successfully evaluated the safety and efficacy of terlipressin injection for HRS type 1 patients. 

Doctors outside the US have used terlipressin for more than 30 years. Finally, in 2022, this new drug for kidney disease gained standard recommendations from the American College of Gastroenterology guidelines and the American Association for the Study of Liver Diseases guidance. 

Terlipressin is a revolutionary innovation as people with HRS suffer from rapid deterioration of kidney function. It often leads to acute renal failure and, ultimately, death. Terlipressin will significantly improve kidney function. The injection will also lessen the need for renal replacement therapy for people undergoing HRS treatment.

Get in touch with the best nephrologists at top nephrology hospitals in India.

More Details: terlipressin (Terlivaz) Phase 3 Trial

Researchers assessed the effectiveness of terlipressin in a dose-ranging study. There were two groups of participants with a rapid reduction in kidney function due to HRS. 

0.85 mg of terlipressin or placebo was given to patients every six hours. The medicine was given as an injection for a maximum of 14 days. Doctors adjusted the dose of the medications for kidney disease based on changes in kidney function.

Researchers published the trial results in The New England Journal of Medicine in 2021. As per the report, 29% of participants in the terlipressin group saw renal function improvement. In the placebo group, only 16% of participants saw improvement. Doctors consider improvement in kidney function when serum creatinine levels are ≤1.5 mg/dL for two consecutive days. 

Safety information

Like any other drug, the discovery of terlipressin injection for renal function improvement during HRS comes with risks. 

 Terlipressin GroupPlacebo Group
Dyspnea 12.5%5.1%
Abdominal pain19.5%6.1%

Terlipressin will hit the market in a few weeks. Ensure to communicate clearly with your doctor about your entire medical history before you begin treatment with terlipressin.


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Question and Answers

Firstly, approximately 20 years ago, I experienced a significant shoulder impact while playing football, resulting in a sprain that extends from my neck to the back of my shoulder. Whenever I engage in physical activity, particularly on the injured right shoulder side, I feel a burning sensation accompanied by heat. Additionally, I've noticed that my right hip appears elevated since the injury. In a previous scan, I discovered a left-sided disc prolapse. Moreover, I occasionally experience sprains in the middle of my back. I have not been taking any medications for this issue as previous doctors have been unable to identify the problem. I am concerned about the long-term implications and would greatly appreciate your expertise in evaluating and providing guidance on the appropriate course of action. Are there any specific tests or examinations that you recommend to better understand the underlying causes and potential treatment options for my shoulder, hip, and back issues? Furthermore, I recently discovered that I have kidney stones in both of my kidneys. I do not have diabetes or high blood pressure, and I am not diagnosed with arthritis. Additionally, I have been informed that I have elevated uric acid levels. Considering these multiple health concerns, I am wondering if blood tests or any other diagnostic tests would be beneficial in identifying any potential connections between these issues and guiding the most appropriate treatment plan.

Male | 44

To address your musculoskeletal concerns consult an orthopedic specialist. They would recommend imaging studies, physical therapy, and medications as needed. For your kidney stones and elevated uric acid, seek guidance from a urologist nearest to you or a nephrologist who can perform diagnostic tests. I suggest to follow certain dietary changes, and monitor your kidney health. Open communication with your specialists for a tailored treatment plan for your multiple health concerns.

Answered on 27th Sept '23

Dr. Neeta Verma

Dr. Neeta Verma

I am 50years.i am dialysis my HCV report is I'm very weak, can't stand properly.what i eat then vomit after few RNA titre report will get next Wednesday. Now what should i do?pressure is always fluctuating.i follow nephrologist prescription and take the medicines but now i become very incapable to do anything. Please suggest me.hepatologist of sskm suggested 1st collect the hepatitis c reports then visit him.

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Do exactly what your doctor said 

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Dr. Pallab Haldar

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Contrast Enhanced Computed Tomography of the whole abdomen showing moderate hypatomegaly with coarse attentuation, edematous GB mild dilated portal vein,splenomegaly,diverticulituis in sigmoid colon. Crystitis. My brother suresh kumar's report has been admitted in Maharaja Agrasain Hospital, Punjabi Bagh and the doctor has recommended us for a second opinion. Kindly advise / suggest next course of action if possible.

Male | 44

WhatsApp the report to me

Answered on 30th July '22

Dr. Pallab Haldar

Dr. Pallab Haldar

30 year old, creatine and urea level high, diarrheas, from past 4 days. Back ache.

Male | 30

 you need to visit emergency department if your bp is more than 180/100 and having symptoms like headache for properly evaluation and management of your condition. This could be hypertensive emergency and needs immediate ecg and bp lowering medication to avoid possible complications.

Answered on 13th May '22

Dr. Ramit Sambyal

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