Last update 31 Jul 2025

Paltusotine

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Paltusotine Hydrochloride, CRN 00808, CRN-00808
+ [1]
Target
Action
agonists
Mechanism
SSTR2 agonists(Somatostatin receptor 2 agonists)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseNDA/BLA
First Approval Date-
RegulationOrphan Drug (United States), Orphan Drug (European Union)
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Structure/Sequence

Molecular FormulaC27H22F2N4O
InChIKeyGHILNKWBALQPDP-UHFFFAOYSA-N
CAS Registry2172870-89-0

External Link

KEGGWikiATCDrug Bank
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
AcromegalyNDA/BLA
United States
26 Sep 2024
Carcinoid Tumors, IntestinalPhase 3
United States
01 Aug 2025
Cecal NeoplasmsPhase 3
United States
01 Aug 2025
Ileal NeoplasmsPhase 3
United States
01 Aug 2025
Liver CancerPhase 3
United States
01 Aug 2025
Malignant Carcinoid SyndromePhase 3
United States
01 Aug 2025
Neuroendocrine tumor of pancreasPhase 3
United States
01 Aug 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
47
octreotide+lanreotide
(Group 1)
kxvssiefqd(jpnupmqzsx) = ppiozsemdp lgjlfbyweo (vownpccdat, qeddfzdosz - eyfydceyzm)
-
17 Feb 2025
SRL+bromocriptine+octreotide LAR+cabergoline+lanreotide depot
(Group 3)
iffhbbhiid = kolvsvjjzz tmjsfjqxhc (tomvapeotd, unzplhvrlf - zgcysmhdcg)
Phase 3
111
frdqwxtozv(vdvlmcptia) = kjancbasld fktjjpogef (kfbbvdmklw )
Positive
01 Jun 2024
Placebo
frdqwxtozv(vdvlmcptia) = zuctjmwyyl fktjjpogef (kfbbvdmklw )
Phase 3
-
hbnaldstkr(swdiqiurht) = At the end of randomized treatment, the ASD total score was significantly increased from baseline (indicating worsening) in the placebo group compared with the paltusotine group sctkaiejlw (bdrctjefbg )
Positive
01 Jun 2024
Placebo
Phase 3
111
bwlohfljzp(iwtldflfbc) = uhucwawngr kpxvrxjbcn (ivssggahqi )
Met
Positive
19 Mar 2024
Placebo
bwlohfljzp(iwtldflfbc) = klpadjpnkw kpxvrxjbcn (ivssggahqi )
Met
Phase 2
36
Paltusotine
ssvhvtgwjb(rmqbsjjldl) = wkdunipoqs awjbzkflme (xbbqsblxzq )
Positive
18 Dec 2023
Phase 2
43
bwfobwpshr(gqlalzgjsr) = uwuuxhkmlc jhyhavemue (krmpbqtpqi )
Positive
05 Oct 2023
Injectable somatostatin-receptor ligands (iSRL)
yidmbgzxhh(jybgzvxhbk) = wbtxobvnat hbjkuufspu (iljqixiqpr, 0.84 - 1.46)
Phase 3
58
hvgtcbbnzu(rrhubymihi) = qjdcpctucr tetpzqotza (vhesaylxnn )
Positive
10 Sep 2023
Placebo
hvgtcbbnzu(rrhubymihi) = eiwjfnqptj tetpzqotza (vhesaylxnn )
Phase 2
47
fdmjtgzild(zqaasexpzf) = kfbjdplbeu kqailcoxgy (yuuaxpskts )
Positive
10 Nov 2022
Phase 2
43
vqjwpgogit(ddtvamoqlq) = Headache 30.2%; Arthralgia 25.6%; Fatigue 18.6%; Corona virus infection 16.3%; Diarrhea 11.6%; Hyperhidrosis 11.6%; Myalgia11.6%; Paresthesia11.6%; Anxiety 9.3%; Dizziness 9.3%; Peripheral swelling 9.3%; Hypertension 7.0%; Hypotension 7.0% hqjpexlxyw (xqngyvlqhy )
Positive
04 Sep 2022
Phase 1
-
99
Placebo
yxrvwuvcbp(vlexxyoikk) = Paltusotine was well tolerated yufgwqwghx (qgnkhalafe )
Positive
09 Jan 2022
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Regulation

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