TheraRadar
Data updated: May 26, 2026

SOMAVERT (pegvisomant)

Trial Activity: Declining 1 active trials
Endocrine Approved 2003-03-25

SOMAVERT is indicated for the treatment of Acromegaly.

Source: FDA Label • PHARMACIA
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How SOMAVERT Works

Pegvisomant selectively binds to growth hormone (GH) receptors on cell surfaces, which blocks endogenous growth hormone from binding to those receptors. This action interferes with GH signal transduction and inhibits the biological activity of growth hormone. Consequently, the drug decreases serum concentrations of IGF-1 and other GH-responsive proteins, such as the acid-labile subunit of IGF-1 and insulin-like growth factor binding protein-3.

Source: FDA Label

Development Insights

Pfizer conducting 5 trials (45%)
14 indications explored (Broad Platform)
→ bioavailability (4 trials)
→ acromegaly (2 trials)
→ insulin receptor mutation (1 trials)
3
Indications
--
Phase 3 Trials
1
Priority Reviews
23
Years on Market

Details

Status
Prescription
First Approved
2003-03-25
Patent Cliff
2010

Pro Metrics

Patent cliff and revenue data

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Routes
SUBCUTANEOUS
Dosage Forms
INJECTABLE

Companies

PHARMACIA
Active Ingredient: PEGVISOMANT

SOMAVERT Approval History

2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
95 FDA actions from 2003 to 2023 · 2 indication expansions
Jul 2023 SUPPL
Efficacy
FDA Letter Label
Aug 2021 SUPPL
Label · Labeling
Label
Sep 2019 SUPPL
Label · Labeling
FDA Letter

What SOMAVERT Treats

1 indications

SOMAVERT is approved for 1 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Acromegaly
Source: FDA Label

SOMAVERT Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

MoA expansion candidates

8

Same target(s), different indications — where else is this mechanism being explored?

NGENLA
Pfizer
2023 1 indic.
SOGROYA
Novo Nordisk
2020 2 indic.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

PALSONIFY
CRINETICS
2025 1 indic.
BYNFEZIA PEN
Sun Pharma
2024 5 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to SOMAVERT

3 of 10

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

BYNFEZIA PEN
OCTREOTIDE ACETATE
1 shared
Sun Pharma
Shared indications:
Acromegaly
LANREOTIDE ACETATE
LANREOTIDE ACETATE
1 shared
INVAGEN PHARMS
Shared indications:
Acromegaly
MYCAPSSA
OCTREOTIDE ACETATE
1 shared
CHIESI
Shared indications:
Acromegaly
View all 10 similar drugs Pro
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Clinical Trial Registry

8 trials
Trial Sponsor ID Phase Status Title
NCT05470504 10000756 000756-DK Ph 2 recruiting Study of Growth Hormone Inhibition Using Pegvisomant in Severe Insulin Resistance
NCT03882034 190071 19-CH-0071 Ph 3 completed Safety and Efficacy of Pegvisomant in Children With Growth Hormone Excess
NCT02952885 I-Con CCHIK-01 Ph 3 completed Strict IGF-1 Control in Acromegaly
NCT01701973 results posted 120078 1K23HL119602 Ph 4 completed Effect of DPP4 Inhibition on Growth Hormone Secretion
NCT02023918 PEGIR results posted WI178028 Ph 2 completed Role of Growth Hormone Antagonism in Modulating Insulin Sensitivity in Subjects With Pre-diabetes
NCT00976508 results posted A4021040 Ph 1 terminated Figitumumab Combined With Pegvisomant For Advanced Solid Tumors
NCT01181973 A6291026 Ph 1 completed Safety, Tolerability and Relative Bioavailability of Pegvisomant in Healthy Subjects
NCT00595140 EudraCT-Nr. 2007-005585-12 EudraCT-Nr. 2007-005585-12 Ph 4 completed Acute Application of Pegvisomant and Octreotide in Acromegaly
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

SOMAVERT FDA Label Details

Indications & Usage

FDA Label (PDF)

SOMAVERT is indicated for the treatment of Acromegaly.

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Data Sources

FDA Approval: BLA021106 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment