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Disease

Acromegaly

Late-stage therapeutic developmentEmerging researchRising momentum
MeSHAcromegaly
3
Publications
17
Clinical trials
2024
Latest publication
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this disease.

What's happening now

An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.

Executive briefingUpdating summary…Momentum: Moderate
Key developments
  • 1 regulatory approval from EMA on record.
  • 2 clinical trials expected to report results, the earliest in Q1 2027.
Upcoming Milestones
Clinical Milestones5View
Results posted 1
Results expected 2
Recently completed 1
Other updates 1
Regulatory Updates1View
Activity timeline6

Therapeutic landscape

Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.

Approved & established therapies
Paltusotine hydrochlorideapproved

Approval — Palsonify is indicated for the medical treatment of adult patients with acromegaly. (2026)

Octreotideapproved

Approval — Oczyesa is indicated for maintenance treatment in adult patients with acromegaly who have… (2025)

Pasireotideapproved

Approval — Signifor is indicated for the treatment of adult patients with Cushing’s disease for whom… (2012)

Pegvisomantapproved

Approval — Treatment of adult patients with acromegaly who have had an inadequate response to surger… (2002)

Clinical trials

11 sponsors · 3 new · 0 completed in the last 12 months (net +2)

The current development programme across all trial phases.

Clinical programme
17
All trials
4
Active
14
Late-stage
6
Completed
Late-stage studies

A Phase 3 Randomized 3-arm Trial (Double-blind Debio 4126, Placebo Control, and Open-label Debio 4126), to Assess the Efficacy and Safety of Debio 4126, a 12-week Octreotide Formulation, in Patients With Acromegaly Previously Treated With Somatostatin Analogs

Phase 3 · Recruiting · Debiopharm International SA

A Randomized, Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Paltusotine in Subjects With Acromegaly Treated With Long-acting Somatostatin Receptor Ligands (PATHFNDR-1)

Phase 3 · Active, not recruiting · Crinetics Pharmaceuticals Inc.

A Multi-center, Randomized, Open-label, Phase IV Study to Investigate the Management of Pasireotide-induced Hyperglycemia With Incretin Based Therapy or Insulin in Adult Patients With Cushing's Disease or Acromegaly

Phase 4 · Completed · Novartis Pharmaceuticals

A Phase 3, Open-label, Single-arm, Multi-center Trial to Assess the Long-term Safety of Octreotide Subcutaneous Depot (CAM2029) in Patients With Acromegaly

Phase 3 · Completed · Camurus AB

A Phase 3, Randomized, Active Controlled Study to Evaluate Maintenance of Response, Safety and Patient Reported Outcomes in Acromegaly Patients Treated With Octreotide Capsules vs. Parenteral Somatostatin Receptor Ligands

Phase 3 · Completed · Chiasma, Inc.

Strict IGF-1 Control in Acromegaly (I-Con Study)

Phase 3 · Completed · Unity Health Toronto
Recruiting

A Phase 3 Randomized 3-arm Trial (Double-blind Debio 4126, Placebo Control, and Open-label Debio 4126), to Assess the Efficacy and Safety of Debio 4126, a 12-week Octreotide Formulation, in Patients With Acromegaly Previously Treated With Somatostatin Analogs

Phase 3 · Recruiting · Debiopharm International SA

A Phase 2, Randomized, Double-blinded, Placebo-controlled, Dose Range-finding, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ALXN2420, a Growth Hormone Receptor Antagonist, Administered Subcutaneously in Combination With Somatostatin Analogs in Adult Participants With Acromegaly

Phase 2 · Recruiting · Alexion Pharmaceuticals, Inc.

First in Human, Randomized, Blinded, Placebo-Controlled Single Ascending Dose and Multiple Dose Study of MAR002 in Healthy Men

Phase 1 · Recruiting · Marea Therapeutics
Recently completed

A Phase 3, Open-label, Single-arm, Multi-center Trial to Assess the Long-term Safety of Octreotide Subcutaneous Depot (CAM2029) in Patients With Acromegaly

Phase 3 · Completed · Camurus AB

A Phase 3, Randomized, Active Controlled Study to Evaluate Maintenance of Response, Safety and Patient Reported Outcomes in Acromegaly Patients Treated With Octreotide Capsules vs. Parenteral Somatostatin Receptor Ligands

Phase 3 · Completed · Chiasma, Inc.

Strict IGF-1 Control in Acromegaly (I-Con Study)

Phase 3 · Completed · Unity Health Toronto

A Multi-center, Randomized, Open-label, Phase IV Study to Investigate the Management of Pasireotide-induced Hyperglycemia With Incretin Based Therapy or Insulin in Adult Patients With Cushing's Disease or Acromegaly

Phase 4 · Completed · Novartis Pharmaceuticals

A Phase IIIb Multicenter, Open-label, Single Arm Study to Evaluate the Efficacy and Safety of Pasireotide in Patients With Acromegaly Inadequately Controlled With First Generation Somatostatin Analogues

Phase 3 · Completed · Novartis Pharmaceuticals

A Phase III, Multicenter, Randomized, Parallel-group Study to Assess the Efficacy and Safety of Double-blind Pasireotide LAR 40 mg and Pasireotide LAR 60 mg Versus Open-label Octreotide LAR or Lanreotide ATG in Patients With Inadequately Controlled Acromegaly

Phase 3 · Completed · Novartis Pharmaceuticals

Regulatory timeline

Drug regulatory events matched to this condition by indication — EMA.

First approvals
2026emaApproval — Paltusotine hydrochloride· Palsonify is indicated for the medical treatment of adult patients with acromegaly. source ↗
2025emaApproval — Octreotide· Oczyesa is indicated for maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues. source ↗
2012emaApproval — Pasireotide· Signifor is indicated for the treatment of adult patients with Cushing’s disease for whom surgery is not an option or for whom surgery has failed. Signifor is indicated for the treatment of adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with another somatostatin analogue. source ↗
2002emaApproval — Pegvisomant· Treatment of adult patients with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalize IGF-I concentrations or was not tolerated. Treatment of adult patients with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalize IGF -I concentrations or was not tolerated. source ↗
Safety updates
2025emaMarket withdrawal — Octreotide· Mycapssa is indicated for maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues. source ↗

European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.

Research activity

3 papers

Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.

Publications over time
20202024
Most influential

A Consensus on the Diagnosis and Treatment of Acromegaly Comorbidities: An Update.

The Journal of clinical endocrinology and metabolism · 2020 · 204 cites

Management of pasireotide-induced hyperglycemia in patients with acromegaly: An experts' consensus statement.

Frontiers in endocrinology · 2024 · 13 cites

Cancer in growth hormone excess and growth hormone deficit.

Endocrine-related cancer · 2023 · 12 cites
Recent publications

Management of pasireotide-induced hyperglycemia in patients with acromegaly: An experts' consensus statement.

Frontiers in endocrinology · 2024 · 13 cites

Cancer in growth hormone excess and growth hormone deficit.

Endocrine-related cancer · 2023 · 12 cites

A Consensus on the Diagnosis and Treatment of Acromegaly Comorbidities: An Update.

The Journal of clinical endocrinology and metabolism · 2020 · 204 cites
Major themes5
  • Acromegaly2
  • Human Growth Hormone1
  • Hyperglycemia1
  • Neoplasms1
  • Quality of Life1
Leading journals3
  • Endocrine-related cancer1
  • Frontiers in endocrinology1
  • The Journal of clinical endocrinology and metabolism1
Leading researchers8
  • Acosta W1
  • Barkan A1
  • Beckers A1
  • Biermasz N1
  • Biller BMK1
  • Boguszewski C1
  • Bolanowski M1
  • Bonert V1
Affiliations (unnormalised)6
  • 3rd Faculty of Medicine of the Charles University and University Hospital Kralovske Vinohrady1
  • and Metabolism and Pituitary Center1
  • Cedars-Sinai Medical Center1
  • Charité Universitätsmedizin1
  • CIBER and CIBERES Germans Trias i Pujol Research Institute and Hospital1
  • David Geffen School of Medicine1

Reference

Authoritative identity, definition & identifiers.

Defined in MeSH

A condition caused by prolonged exposure to excessive HUMAN GROWTH HORMONE in adults. It is characterized by bony enlargement of the FACE; lower jaw (PROGNATHISM); hands; FEET; HEAD; and THORAX. The most common etiology is a GROWTH HORMONE-SECRETING PITUITARY ADENOMA. (From Joynt, Clinical Neurology, 1992, Ch36, pp79-80)

Identifiers
MeSHAcromegaly
References & data sources
  • Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
  • Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
  • Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
  • Related entities are derived from literature co-mention (studied together) — associative, not causal.