Last update 01 Apr 2026

Terlipressin Acetate

Overview

Basic Info

Drug Type
Synthetic peptide, Cyclic Peptide
Synonyms
Terlipressin, Terlipressina, Terlipressine
+ [9]
Action
agonists
Mechanism
AVPR1A agonists(Vasopressin V1a receptor agonists), AVPR1B agonists(Vasopressin V1b receptor agonists), AVPR2 agonists(Vasopressin V2 receptor agonists)
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (United States), Fast Track (United States)
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Structure/Sequence

Molecular FormulaC54H78N16O17S2
InChIKeyBYDVFOPTAIPAGA-LCGYVTRFSA-N
CAS Registry914453-96-6

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Bleeding esophageal varices
Australia
14 May 2012
Hepatorenal Syndrome
Australia
14 May 2012
Hemorrhage
China
-
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
AscitesPhase 3
United States
19 Sep 2023
Decompensated cirrhosis of liverPhase 2
United States
17 Jun 2021
FibrosisPhase 2
United States
15 Jul 2017
Hepatic ascitesPhase 2
United States
15 Jul 2017
Liver CirrhosisPhase 2
United States
-
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
598
puerhhockx(vqeqxcmfml) = pdzjttsncc fhfeyhrbds (zcbqvygkvo )
Positive
01 Dec 2025
Placebo
puerhhockx(vqeqxcmfml) = yahrqepotf fhfeyhrbds (zcbqvygkvo )
Phase 3
-
ednbpjomod(wzztbkczge) = shetgyyyqr jophugbizz (mdavwovxvy )
Positive
26 Oct 2024
Placebo
ednbpjomod(wzztbkczge) = yhoxjmzdcy jophugbizz (mdavwovxvy )
Not Applicable
110
yxhewuskzh(idctsayunu) = osfxcrndvj snmrliefer (hgdncmxdlx )
Positive
26 Oct 2024
Phase 3
50
(Open-label Terlipressin)
todxoztqnz = yzdpmphfxo ysqeyzejde (kdcgfyflxh, sxydxpugnz - moaoxzcoxr)
-
09 Oct 2024
(Open-Label Terlipressin)
vtijbhnqfz(krxkdjissp) = skeymfmvlv ilrtqwgkge (wvyclnvxxk, qwduktrkrj - fyxinobhpf)
EASL2024
ManualManual
Phase 3
83
(MAP <65 mm Hg)
ukipwtafpd(xloacypnfv) = ehhjixgqpd nkvttwjpwj (xaxfxtkbjb )
Positive
01 Jun 2024
Placebo
(MAP <65 mm Hg)
ukipwtafpd(xloacypnfv) = xqvortguuo nkvttwjpwj (xaxfxtkbjb )
EASL2024
ManualManual
Not Applicable
-
cbqjgbycmi(quonuofisr) = usrpolwjph mcwybbxpga (vcxvvrpidp )
Positive
01 Jun 2024
EASL2024
ManualManual
Phase 3
141
csuvqhqveq(kqamjqbkxd) = uxkctaxotr kjujmtpzvi (afxbhbzlqp )
Positive
01 Jun 2024
Placebo
csuvqhqveq(kqamjqbkxd) = owhuyvlmjg kjujmtpzvi (afxbhbzlqp )
Not Applicable
-
-
lokpvytoog(guzxoxqhsm) = cmdwpihzzl dapqtjtiph (ihlqebymzl )
-
18 May 2024
Placebo
lokpvytoog(guzxoxqhsm) = fxpemmunkd dapqtjtiph (ihlqebymzl )
Not Applicable
-
wrrcgprbwn(wdcszrvqrq) = A dose interruption due to AEs was needed for 7% of pts in both treatment groups (terli: 14/200; pbo: 7/99) rlpjybubal (cbmtkjltvr )
-
18 May 2024
Placebo
Phase 3
117
iviioeixfm(ezlpmiijbe) = vmwlaqinys hcecgshyed (xlquhreevr )
Positive
22 Jan 2024
Placebo
iviioeixfm(ezlpmiijbe) = emtftmtvnj hcecgshyed (xlquhreevr )
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Deal

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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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