Acromegaly

Endocrinology
45
Pipeline Programs
8
Companies
50
Clinical Trials
2 recruiting
4
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
2
1
12
1
15
14
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Peptide
2496%
Small Molecule
14%
+ 34 programs with unclassified modality

On Market (4)

Approved therapies currently available

Crinetics Pharmaceuticals
PALSONIFYApproved
paltusotine
Crinetics Pharmaceuticals
oral2025
Novartis
SANDOSTATINApproved
octreotide acetate
Novartis
injection1988
Novartis
SANDOSTATIN LARApproved
octreotide acetate
Novartis
injection1998
Pfizer
SOMAVERTApproved
pegvisomant
Pfizer
subcutaneous2003

Competitive Landscape

8 companies ranked by most advanced pipeline stage

Ipsen
IpsenChina - Tianjin
30 programs
1
3
1
7
3
LanreotidePhase 4Peptide1 trial
LanreotidePhase 4Peptide1 trial
Lanreotide Autogel 120 mgPhase 4Peptide1 trial
LanreotidePhase 3Peptide1 trial
Lanreotide Autogel®Phase 3Peptide1 trial
+25 more programs
Active Trials
NCT02012127Completed648Est. Jun 2014
NCT01819883Completed40Est. Mar 2016
NCT05752825Completed34Est. May 2024
+27 more trials
Novartis
NovartisBASEL, Switzerland
9 programs
2
2
5
OctreotidePhase 4Peptide1 trial
Octreotide acetatePhase 4Peptide1 trial
Octreotide acetate and cabergoline/Octrotide and SomavertPhase 4Peptide1 trial
SandostatinPhase 4Small Molecule1 trial
SANDOSTATIN LAR(Sandostatin LAR)Phase 44 trials
+4 more programs
Active Trials
NCT00315107Unknown30Est. Aug 2007
NCT02299089Completed12Est. Jun 2016
NCT06784752Recruiting240Est. Jan 2034
+13 more trials
Pfizer
PfizerNEW YORK, NY
6 programs
1
2
PegvisomantPhase 41 trial
Pegvisomant/ Sandostatin LARPhase 41 trial
PegvisomantPhase 31 trial
Acromegaly Treatment Quality of Life StudyN/A1 trial
CMRIN/A1 trial
+1 more programs
Active Trials
NCT01732406Completed126Est. Dec 2016
NCT02948322Completed28Est. Feb 2019
NCT00658879Completed251Est. Nov 2016
+3 more trials
Crinetics Pharmaceuticals
5 programs
3
2
1
PaltusotinePhase 31 trial
PaltusotinePhase 31 trial
PaltusotinePhase 21 trial
PaltusotinePhase 21 trial
PaltusotinePhase 21 trial
Active Trials
NCT03789656Completed47Est. Aug 2020
NCT04261712Active Not Recruiting43Est. Mar 2028
NCT03792555Completed13Est. Aug 2020
+2 more trials
Camurus
CamurusSweden - Lund
3 programs
1
2
CAM2029Phase 31 trial
CAM2029Phase 31 trial
octreotide FluidCrystal® injection depotPhase 2Peptide
Active Trials
NCT04076462CompletedEst. May 2023
NCT04125836CompletedEst. Apr 2025
Debiopharm
DebiopharmSwitzerland - Lausanne
2 programs
1
1
Debio 4126Phase 31 trial
Debio 4126Phase 11 trial
Active Trials
NCT05364944TerminatedEst. Dec 2024
NCT06930625RecruitingEst. Mar 2029
Ionis Pharmaceuticals
3 programs
3
GHR-LRXPhase 21 trial
IONIS GHR-LRxPhase 21 trial
IONIS-GHR-LRxPhase 21 trial
Active Trials
NCT04522180Completed34Est. May 2023
NCT03967249Completed39Est. Jul 2022
NCT03548415Completed43Est. Apr 2021
Marea Therapeutics
Marea TherapeuticsCA - South SF
1 program
1
MAR002Phase 11 trial
Active Trials
NCT07195175RecruitingEst. Jul 2026

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
NovartisSandostatin
IpsenLanreotide Autogel 120 mg
NovartisOctreotide LAR
NovartisSandostatin LAR
NovartisSandostatin LAR
NovartisOctreotide acetate and cabergoline/Octrotide and Somavert
IpsenLanreotide
IpsenLanreotide
PfizerPegvisomant/ Sandostatin LAR
PfizerPegvisomant
NovartisOctreotide acetate
NovartisSandostatin LAR
NovartisOctreotide
DebiopharmDebio 4126
NovartisOctreotide LAR

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 3,408 patients across 50 trials

NCT02427295NovartisSandostatin

Hormonal Outcomes in Acromegalic Patients With Treated Surgery With or Without Long Acting Somatostatin Analogues

Start: Mar 2014Est. completion: Dec 20191 patients
Phase 4Unknown
NCT00701363IpsenLanreotide Autogel 120 mg

Study to Assess the Efficacy of an Extended Injection Interval Schedule of Lanreotide Autogel in Acromegalic Subjects

Start: Oct 2008Est. completion: May 2013124 patients
Phase 4Completed
NCT00552071NovartisOctreotide LAR

Ultrasound Guided Octreotide LAR Injection in Acromegaly

Start: Jul 2007Est. completion: Mar 201415 patients
Phase 4Completed
NCT01424241NovartisSandostatin LAR

Effects of Sandostatin LAR® in Acromegaly

Start: Oct 2006Est. completion: Jan 201421 patients
Phase 4Completed
NCT01278342NovartisSandostatin LAR

Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients

Start: Sep 2006Est. completion: Nov 200970 patients
Phase 4Completed
NCT00376064NovartisOctreotide acetate and cabergoline/Octrotide and Somavert

Efficacy of Octreotide Acetate and Cabergoline in Patients With Acromegaly

Start: Mar 200620 patients
Phase 4Completed
NCT00216398IpsenLanreotide

Lanreotide Autogel in Patients With Acromegaly Previously Treated With Octreotide LAR

Start: Jun 2004Est. completion: Jun 20068 patients
Phase 4Completed
NCT00149188IpsenLanreotide

Somatuline Autogel: Acromegaly Self/Partner Injection Study

Start: Feb 2004Est. completion: Aug 200530 patients
Phase 4Completed
NCT00068029PfizerPegvisomant/ Sandostatin LAR

Pegvisomant And Sandostatin LAR Combination Study

Start: Oct 2003Est. completion: May 200675 patients
Phase 4Completed
NCT00068042PfizerPegvisomant

A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly

Start: Apr 2003Est. completion: May 2006100 patients
Phase 4Completed
NCT00242541NovartisOctreotide acetate

Study Assessing the Efficacy and Safety of Octreotide Acetate in Patients With Acromegaly, With Micro or Macroadenomas

Start: Mar 200350 patients
Phase 4Terminated
NCT00050635NovartisSandostatin LAR

STOP Trial - Sandostatin LAR Depot Trial for the Optimum Prevention of Chemotherapy Induced Diarrhea

Start: Dec 2002Est. completion: Jul 2003150 patients
Phase 4Completed
NCT00171886NovartisOctreotide

Octreotide Efficacy and Safety in First-line Acromegalic Patients

Start: Jul 2002Est. completion: May 200620 patients
Phase 4Completed
NCT06930625DebiopharmDebio 4126

A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs

Start: Nov 2025Est. completion: Mar 2029
Phase 3Recruiting
NCT06784752NovartisOctreotide LAR

Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET

Start: May 2025Est. completion: Jan 2034240 patients
Phase 3Recruiting
NCT05192382Crinetics PharmaceuticalsPaltusotine

A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (PATHFNDR-2)

Start: Dec 2021Est. completion: Jan 2028111 patients
Phase 3Active Not Recruiting
NCT04837040Crinetics PharmaceuticalsPaltusotine

A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly

Start: May 2021Est. completion: Jun 202758 patients
Phase 3Active Not Recruiting
NCT04125836CamurusCAM2029

A Trial to Assess the Long-term Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly

Start: Oct 2019Est. completion: Apr 2025
Phase 3Completed
NCT04076462CamurusCAM2029

A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly

Start: Aug 2019Est. completion: May 2023
Phase 3Completed
NCT02493517IpsenLanreotide Autogel®

Efficacy and Safety of Lanreotide Autogel® 60, 90 or 120 mg With Lanreotide 40 mg Prolonged Release (PR) in Acromegaly

Start: Oct 2014Est. completion: Feb 2017128 patients
Phase 3Completed
NCT01137682NovartisOctreotide LAR

Efficacy and Safety of Pasireotide Long Acting Release (LAR) Versus Octreotide LAR or Lanreotide Autogel (ATG) in Patients With Inadequately Controlled Acromegaly

Start: Jul 2010Est. completion: Feb 2017198 patients
Phase 3Completed
NCT00690898IpsenLanreotide autogel 120 mg

Lanreotide as Primary Treatment for Acromegalic Patients With Pituitary Gland Macroadenoma

Start: May 2008Est. completion: Feb 2012108 patients
Phase 3Completed
NCT00582426NovartisOctreotide LAR

Evaluation of Octreotide LAR in Prevention of Chemotherapy-induced Diarrhea

Start: Apr 2008Est. completion: Sep 2010139 patients
Phase 3Completed
NCT00600886NovartisOctreotide LAR

Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly

Start: Feb 2008Est. completion: Mar 2016358 patients
Phase 3Completed
NCT00447499IpsenSomatuline Autogel

Assessment of the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel

Start: Apr 2007Est. completion: Dec 200859 patients
Phase 3Completed
NCT00383708Ipsenlanreotide

Lanreotide Autogel and Pegvisomant Combination Therapy in Acromegalic Patients

Start: Oct 2006Est. completion: Oct 2008125 patients
Phase 3Completed
NCT00372697NovartisOctreotide acetate 30 mg suspension

Efficacy/Safety of Octreotide Acetate in Patients With Uncontrolled Acromegaly

Start: Dec 2005Est. completion: Oct 200728 patients
Phase 3Completed
NCT00444873Ipsenlanreotide

Effect of 120mg Somatuline Autogel at Different Dose Intervals (28, 42 or 56 Days) in Patients With Acromegaly

Start: Jan 2005Est. completion: Jan 200838 patients
Phase 3Completed
NCT00143416PfizerPegvisomant

Long Term Study With B2036-PEG

Start: Apr 2004Est. completion: Jul 200716 patients
Phase 3Completed
NCT00128232NovartisOctreotide LAR

Safety and Efficacy of Octreotide Long Acting Release (LAR) in Treatment Naïve Acromegalic Patients

Start: Dec 2002100 patients
Phase 3Completed
NCT00225979NovartisOctreotide LAR

Safety and Efficacy of Long-acting Repeatable Octreotide Acetate for Injectable Suspension vs. Surgery in Treatment-naïve Patients With Acromegaly

Start: Nov 2002Est. completion: Mar 2005100 patients
Phase 3Completed
NCT00499993Ipsenlanreotide

Efficacy and Tolerability of Lanreotide (Autogel 120 mg) in Patients With Acromegaly

Start: Jan 2001Est. completion: May 200363 patients
Phase 3Completed
NCT00210457IpsenLanreotide

Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients

Start: Sep 2000Est. completion: Jul 200263 patients
Phase 3Completed
NCT00234572IpsenLanreotide

Efficacy and Safety Study of Varying Doses of Lanreotide Autogel in Patients With Acromegaly

Start: May 2000Est. completion: Jan 2003108 patients
Phase 2/3Completed
NCT04522180Ionis PharmaceuticalsGHR-LRX

A Study to Assess the Safety, Tolerability, and Efficacy of IONIS-GHR-LRx Administered in Patients With Acromegaly

Start: Jan 2021Est. completion: May 202334 patients
Phase 2Completed
NCT04261712Crinetics PharmaceuticalsPaltusotine

A Study to Evaluate the Long-Term Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Advance)

Start: Jan 2020Est. completion: Mar 202843 patients
Phase 2Active Not Recruiting
NCT03967249Ionis PharmaceuticalsIONIS GHR-LRx

Extension Study of IONIS-GHR-LRx Administered to Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands

Start: Jul 2019Est. completion: Jul 202239 patients
Phase 2Completed
NCT03789656Crinetics PharmaceuticalsPaltusotine

An Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Edge)

Start: Mar 2019Est. completion: Aug 202047 patients
Phase 2Completed
NCT03792555Crinetics PharmaceuticalsPaltusotine

A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Evolve)

Start: Mar 2019Est. completion: Aug 202013 patients
Phase 2Completed
NCT03548415Ionis PharmaceuticalsIONIS-GHR-LRx

Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands

Start: Sep 2018Est. completion: Apr 202143 patients
Phase 2Completed
NCT03045302IpsenBIM23B065

Assessment of BIM23B065, Given as Repeated Subcutaneous Injection in Subjects With Acromegaly

Start: Jan 2017Est. completion: Jun 20174 patients
Phase 2Terminated
NCT02299089Novartisoctreotide FluidCrystal® injection depot

Phase II Study of Subcutaneous Inj. Depot of Octreotide in Patients With Acromegaly and Neuroendocrine Tumours (NETs)

Start: Jan 2015Est. completion: Jun 201612 patients
Phase 2Completed
NCT01886287NovartisOctreotide LAR

P:II Above-Label Octreotide-LAR With Insufficiently Controlled Carcinoid Syndrome

Start: Dec 2013Est. completion: Oct 20142 patients
Phase 2Terminated
NCT01157858NovartisOctreotide LAR

Everolimus and LongActing Octreotide Trial in Polycystic Livers

Start: Jun 2010Est. completion: Jul 201244 patients
Phase 2Completed
NCT00994214IpsenBIM 23A760

Study to Assess the Efficacy and Safety of Repeated Administration of BIM 23A760 in Patients With Acromegaly

Start: Oct 2009Est. completion: Feb 2011109 patients
Phase 2Terminated
NCT00517491Ipsenlanreotide

Study to Evaluate Patients With Acromegaly Treated With Lanreotide Autogel (Somatuline ATG)

Start: May 2008Est. completion: Dec 20080
Phase 2Withdrawn
NCT00315107NovartisAlesse

Estrogen Treatment in Acromegalic Women

Start: May 2006Est. completion: Aug 200730 patients
Phase 2Unknown
NCT00332696NovartisOctreotide LAR

Octreotide Compared to Placebo in Patients With Inoperable Bowel Obstruction Due to Peritoneal Carcinomatosis

Start: Sep 2005Est. completion: Sep 200864 patients
Phase 2Completed
NCT00166725NovartisOctreotide LAR

Effects of Octreotide Acetate on Circulating Levels of Chromogranin A in Advanced Prostate Cancer Patients

Start: Feb 200440 patients
Phase 2Completed
NCT00094146NovartisSandostatin LAR

Sandostatin LAR® Depot in Patients With Primary Insulin Hypersecretion (PIH) and at Least Moderate Obesity

Start: Jan 2002Est. completion: Dec 2002160 patients
Phase 2Completed

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

15 late-stage (Phase 3) programs — potential near-term approvals
2 actively recruiting trials targeting 3,408 patients
8 companies competing in this space

Related Indications

Growth Hormone Deficiency(39)Growth Hormone Disorder(37)Hypogonadism(21)Secondary Hyperparathyroidism(13)Hypoparathyroidism(12)Thyroid Eye Disease(11)Adult Growth Hormone Deficiency(10)Hypothyroidism(9)Cushing's Syndrome(9)Growth Hormone Deficiency in Children(5)