Last update 04 Jun 2026

Octreotide Acetate

Overview

Basic Info

Drug Type
Synthetic peptide, Cyclic Peptide
Synonyms
Octreotide acetate (USP), Octreotide Acetate Microspheres, 奥曲肽
+ [29]
Target
Action
agonists
Mechanism
SSTR agonists(Somatostatin receptor agonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (21 Oct 1988),
RegulationOrphan Drug (United States), Orphan Drug (European Union)
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Structure/Sequence

Molecular FormulaC51H70N10O12S2
InChIKeyXQEJFZYLWPSJOV-XJQYZYIXSA-N
CAS Registry79517-01-4

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Gigantism
Japan
20 Jun 2014
Neuroendocrine neoplasm of gastrointestinal tract
Japan
25 Nov 2011
Malignant Carcinoid Syndrome
China
15 Aug 2003
Neuroendocrine Tumors
China
15 Aug 2003
Acromegaly
United States
21 Oct 1988
Carcinoid Tumor
United States
21 Oct 1988
Vipoma
United States
21 Oct 1988
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Hepatorenal SyndromePhase 3
Canada
01 Oct 2005
Drug-induced diarrheaPhase 3
United States
01 Dec 1999
Metastatic colon cancerPhase 3
United States
01 Dec 1999
Metastatic Colorectal CarcinomaPhase 3
United States
01 Dec 1999
Nonproliferative diabetic retinopathyPhase 3
United States
01 Nov 1999
Proliferative retinopathy with diabetes mellitusPhase 3
United States
01 Nov 1999
SarcoidosisPhase 2
Netherlands
27 Feb 2014
Neuroendocrine CarcinomaPhase 2
United States
01 Dec 2013
Congenital HyperinsulinismPhase 2
France
01 May 2009
Castration-Resistant Prostatic CancerPhase 2
United States
01 Jul 2007
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
256
ujyubpfopp(bvhiiojvvk) = ginqzjbjqk stpaatobry (naxdmdzmrf )
Negative
20 Mar 2026
Placebo +
Octreotide LAR
ujyubpfopp(bvhiiojvvk) = ixkeilelzz stpaatobry (naxdmdzmrf )
Not Applicable
30
Off-label molecularly targeted systemic therapies
mqbwnoasth(fhkuhebzds) = occurred in one patient. fbjpcapwgq (mikowxyyhs )
Positive
16 Oct 2025
Phase 2
39
leclnjajkd(klwlqgjmbv) = tnahptxucs ttthqmnvqe (aldinaenfa, 3.3 - 27.5)
Positive
10 Oct 2025
Not Applicable
122
tcxwiqtcsi(tgenflnxgf) = gastrointestinal symptoms (20.5%), hepatobiliary injuries (31.1%), and transient hyperglycemia (49.2%). Only one patient developed necrotizing enterocolitis. pwfdhhbdhh (oalxvuilrg )
Positive
16 Nov 2024
Not Applicable
230
Oral Octreotide Capsules (OOC)
dcsotjqgkp(avdshxxrfs) = lyoceyuguv bvpetgvsus (kvqheqyjmg, 0.8)
-
01 Jun 2024
Monotherapy with OOC
tlicdwqztz(djgamgpieu) = jzycukkrij vebaikpodf (lmvqsljdac )
Not Applicable
-
Long-acting release-octreotide (LAR-OCT)
ajffagbaet(rcbgmtcdwh) = Adverse events were registered in 2 patients, leading to drug suspension in only 1 (dysrhythmia) bltdscflcm (nzmrabjbsh )
-
15 Oct 2023
Not Applicable
21
psvbdnliex(fyqqotwmnu) = akufaedygx jswujayniv (xlrnhhuoye, 15.0)
Positive
09 Sep 2023
Not Applicable
-
-
hhefsqgprh(qgzaqdzxdq) = qemsmqbcqs ndirawkntc (giigwmxwcr, -0.1 to 0.7)
-
09 Oct 2022
(Standard Care)
hhefsqgprh(qgzaqdzxdq) = fukllzwboz ndirawkntc (giigwmxwcr, 0.8 - 1.6)
Phase 2
Second line
56
anitjusvim(mwnlelollb) = mxcbuglquh fgelcdxhqx (phnlaeaypw )
-
03 Jul 2021
Phase 3
-
Oral Octreotide Capsules (OOC)
gkxgdawmwb(mlrcltphnd) = awzffexvwf lzhyjsfptp (zmlempbgow )
Positive
03 May 2021
apjjyxqpji(ibkflaoven) = nnczzhqhfx ieromfsycv (wchpatfasy )
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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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