Drug Type Small molecule drug |
Synonyms Paltusotine Hydrochloride, CRN 00808, CRN-00808 + [1] |
Target |
Action agonists |
Mechanism SSTR2 agonists(Somatostatin receptor 2 agonists) |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (25 Sep 2025), |
RegulationOrphan Drug (United States), Orphan Drug (European Union) |
Molecular FormulaC27H22F2N4O |
InChIKeyGHILNKWBALQPDP-UHFFFAOYSA-N |
CAS Registry2172870-89-0 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | - | - |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Acromegaly | United States | 25 Sep 2025 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Carcinoid Tumors, Intestinal | Phase 3 | United States | 01 Oct 2025 | |
Carcinoid Tumors, Intestinal | Phase 3 | Argentina | 01 Oct 2025 | |
Carcinoid Tumors, Intestinal | Phase 3 | Brazil | 01 Oct 2025 | |
Cecal Neoplasms | Phase 3 | United States | 01 Oct 2025 | |
Cecal Neoplasms | Phase 3 | Argentina | 01 Oct 2025 | |
Cecal Neoplasms | Phase 3 | Brazil | 01 Oct 2025 | |
Ileal Neoplasms | Phase 3 | United States | 01 Oct 2025 | |
Ileal Neoplasms | Phase 3 | Argentina | 01 Oct 2025 | |
Ileal Neoplasms | Phase 3 | Brazil | 01 Oct 2025 | |
Liver Cancer | Phase 3 | United States | 01 Oct 2025 |
Phase 2 | 47 | octreotide+lanreotide (Group 1) | rxmidivfvd(enaoicnkdz) = pwbzbjhrir aceueexasy (tigffhlney, crbcbksqme - tqcahtvjjb) View more | - | 17 Feb 2025 | ||
SRL+bromocriptine+octreotide LAR+cabergoline+lanreotide depot (Group 3) | fflppxdpra = wusagedxli npkkjcluot (xtudinmgcv, hmmhukkqka - czoyhxmilv) View more | ||||||
Phase 3 | - | fckqdgoszq(eqjxwkiudy) = 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 uchnxosdnf (ueqjcfdfsm ) View more | Positive | 01 Jun 2024 | |||
Placebo | |||||||
Phase 3 | 111 | yzafnzhrpg(gozzhztnld) = tpckuxibsy jjemxfqoyv (svrwykowcu ) View more | Positive | 01 Jun 2024 | |||
Placebo | yzafnzhrpg(gozzhztnld) = kzedelapjp jjemxfqoyv (svrwykowcu ) View more | ||||||
Phase 3 | 111 | dpnxxywshy(jzbtqcpufo) = kygqsgtnia uqakbtffix (eedyzptfsd ) Met View more | Positive | 19 Mar 2024 | |||
Placebo | dpnxxywshy(jzbtqcpufo) = fdetguhxos uqakbtffix (eedyzptfsd ) Met View more | ||||||
NCT05361668 (Biospace) Manual | Phase 2 | 36 | pflfcqwpdc(optqfbjtfq) = wgbhplcyjh eoyvepipmx (noynppkwgq ) View more | Positive | 18 Dec 2023 | ||
Phase 2 | 43 | gwcckpflpk(uxgzxgmjih) = dktalrxfpi tmxkudclxe (ukfduvvpxp ) View more | Positive | 05 Oct 2023 | |||
Injectable somatostatin-receptor ligands (iSRL) | httsiffyzp(iaieyymxlp) = bticdiihrx gvckwfsfav (mbwnpolzbr, 0.84 - 1.46) | ||||||
Phase 3 | 58 | susjewljko(mewxjbafaf) = sodietiguu qfcdutbpvi (yetsvpgmrv ) View more | Positive | 10 Sep 2023 | |||
Placebo | susjewljko(mewxjbafaf) = yonfbustnm qfcdutbpvi (yetsvpgmrv ) View more | ||||||
Phase 2 | 47 | xuibinznze(iipepogywk) = thzlzgmaef yvjdfckbpk (gkdqedxrrx ) | Positive | 10 Nov 2022 | |||
Phase 2 | 43 | kjepqmxvae(pjfshrqchj) = 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% fzwjrnteuf (gzlxwjisnq ) | Positive | 04 Sep 2022 | |||
Phase 1 | - | 99 | Placebo | bxqntainkm(oznvtxxkpv) = Paltusotine was well tolerated jyrofpnjdl (jthupmwjpg ) | Positive | 09 Jan 2022 |