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Drug

Pasireotide

Approved · EMA
Emerging researchLate-stage developmentRising momentum
Also known as Signifor, cyclo((4R)-4-(2-aminoethylcarbamoyloxy)-L-prolyl-L-phenylglycyl-D-tryptophyl-L-lysyl-4-O-benzyl-L-tyrosyl-L- phenylalanyl-), Pasireotida, Pasiréotide+1 more

Signifor, cyclo((4R)-4-(2-aminoethylcarbamoyloxy)-L-prolyl-L-phenylglycyl-D-tryptophyl-L-lysyl-4-O-benzyl-L-tyrosyl-L- phenylalanyl-), Pasireotida, Pasiréotide, Pasireotidum.

RxNorm1364105ChEMBLCHEMBL3349607ATCH01CB05UNII98H1T17066
4
Research papers
2
Active clinical trials
1
Regulatory events
Latest activity
beta

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

Pasireotide Treatment for Patients With Prolactinomas Who Need Treatment Beyond Dopamine Agonist Therapy

Clinical trial2026-03-04Results expected Q1 2027 · ClinicalTrials.gov

An Open Label, Multi-center Pasireotide Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Pasireotide Study and Are Judged by the Investigator to Benefit From Continued Pasireotide Treatment

Clinical trial2024-10-01Results posted · ClinicalTrials.gov

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

Research2024-02-09Frontiers in endocrinology

Prevention of Gastrointestinal Toxicity From Total Body Irradiation or High Dose Chemotherapy With Pasireotide

Clinical trial2021-11-17Results posted · ClinicalTrials.gov

Extension to a Multi-Center, Randomized, Crossover, Open Label, Dose Finding Study to Compare the Safety, Efficacy, and Pharmacokinetics/Pharmacodynamics (PK/PD) Relationship of Multiple Doses of Pasireotide (SOM230) (200, 400, and 600 μg Bid) and Doses of Open Label Sandostatin® (SMS) (100 μg Tid) in Acromegalic Patients

Clinical trial2021-09-05Results posted · ClinicalTrials.gov

Extension to a Multicenter, Open-label Study to Assess the Safety and Efficacy of 600 μg SOM230, Administered Subcutaneously, Bid in Patients With Cushing's Disease

Clinical trial2021-06-02Results posted · ClinicalTrials.gov

Phase I/II Trial to Establish the Safety and Preliminary Efficacy of the Combination of Docetaxel, Prednisone, and SOM 230 (Pasireotide) in Metastatic Castrate Resistant Prostate Cancer (CRPC).

Clinical trial2021-03-25Results posted · ClinicalTrials.gov

A 3-Arm Randomized Phase II Trial Evaluating Single Agent and Combined Efficacy of Pasireotide and Everolimus in Adult Patients With Radioiodine-Refractory Differentiated and Medullary Thyroid Cancer

Clinical trial2021-02-17Results posted · ClinicalTrials.gov

Extended treatment of Cushing's disease with pasireotide: results from a 2-year, Phase II study.

Research2014-08-01Pituitary

Long-term efficacy and safety of subcutaneous pasireotide in acromegaly: results from an open-ended, multicenter, Phase II extension study.

Research2014-04-01Pituitary

Hyperglycemia associated with pasireotide: results from a mechanistic study in healthy volunteers.

Research2013-06-03The Journal of clinical endocrinology and metabolism

Approval: Signifor (EMA)

Regulatory2012-04-24EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Pasireotide
Aliases & brands
Signiforcyclo((4R)-4-(2-aminoethylcarbamoyloxy)-L-prolyl-L-phenylglycyl-D-tryptophyl-L-lysyl-4-O-benzyl-L-tyrosyl-L- phenylalanyl-)PasireotidaPasiréotidePasireotidum
RxNorm CUI
1364105
ChEMBL ID
CHEMBL3349607
ATC codes
H01CB05
UNII
98H1T17066
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2012-04-24
Latest approval
2012-04-24
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2012-04-24Approval
Approval: Signifor (EMA)
Indication: 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… Show full indication

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.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

31 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
31
registered trials across all phases
LATEST COMPLETION 2023
2
Active studies
1
Recruiting
9
Late-stage (III+)
24
Completed
5
Discontinued
PHASE DISTRIBUTIONn = 31
Phase 15Phase 1 / 21Phase 216Phase 2 / 31Phase 35Phase 43

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

HYPAR Trial - Hydrocortisone vs Pasireotide in Reducing Pancreatic Fistula and Other Complications After Pancreatic Resection - a Prospective, Randomized, Controlled Trial

Active, not recruitingPH IVHelsinki University Central Hospitaln=1262029

An Open Label, Multi-center Pasireotide Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Pasireotide Study and Are Judged by the Investigator to Benefit From Continued Pasireotide Treatment

CompletedPH IVRECORDATI GROUPn=3372023

Pasireotide Treatment for Insulin Producing Pancreatic Neuro-endocrine Tumor

WithdrawnPH IVUniversity of Maryland, Baltimore2016

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

CompletedPH IIINovartis Pharmaceuticalsn=1982017

A Multicenter, Randomized, Blinded Study to Assess Safety and Efficacy of Pasireotide LAR vs. Octreotide LAR in Patients With Active Acromegaly

CompletedPH IIINovartis Pharmaceuticalsn=3582016

Recent completions

Trials that read out recently, adding to the completed evidence base.

An Open Label, Multi-center Pasireotide Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Pasireotide Study and Are Judged by the Investigator to Benefit From Continued Pasireotide Treatment

CompletedPH IVRECORDATI GROUPn=3372023

Reduction by Pasireotide of the Effluent Volume in High-output Enterostomy in Patients Refractory to Usual Medical Treatment : Phase II Multicentric Randomized Double Bland Placebo Controlled Study

CompletedPH IIHospices Civils de Lyonn=572021

A Three-Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Subcutaneous Doses of HTL0030310 in Healthy Subjects

CompletedPH INxera Pharma UK Limitedn=422020

Prevention of Gastrointestinal Toxicity From Total Body Irradiation or High Dose Chemotherapy With Pasireotide

CompletedPH IIAnthony Sung, MDn=372019

A 3-Arm Randomized Phase II Trial Evaluating Single Agent and Combined Efficacy of Pasireotide and Everolimus in Adult Patients With Radioiodine-Refractory Differentiated and Medullary Thyroid Cancer

CompletedPH IIEmory Universityn=422019

Phase IB/II Study of Pasireotide, Everolimus and Selective Internal Radioembolization Therapy (SIRT) for Unresectable Neuroendocrine Hepatic Metastases

CompletedPH IEmory Universityn=132018

Research activity

4 papers

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

Publications over time
20132024
Major research themes2
Acromegaly1Hyperglycemia1
Journals, researchers & institutions
Top journals
  • Pituitary2
  • Frontiers in endocrinology1
  • The Journal of clinical endocrinology and metabolism1
Leading researchers
  • Hu K2
  • Hughes G2
  • Petersenn S2
  • Schopohl J2
  • Armstrong D1
  • Atkinson AB1
  • Barkan A1
  • Bertherat J1
Leading institutions
free-text, unnormalised
  • Center for Metabolic Research1
  • Dijon University Hospital1
  • ENDOC Center for Endocrine Tumors1
  • German Centre for Diabetes Research (DZD)1
  • Institute for Endocrinology & Diabetes1
  • Ludwig-Maximilians-Universität München1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.