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Sandostatine®
Sandostatine® is a Biologic drug developed by Merck Sharp & Dohme LLC. It is currently in Phase 1 development. Also known as: Octreotide acetate.
Sandostatin is a small molecule used in the treatment of various conditions, including Recurrent Meningioma, Acromegaly, and Type 2 Diabetes Mellitus. It is administered in various forms, including 177Lu-DOTATATE and Lanreotide (Autogel formulation), as part of local standard of care.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Merck Sharp & Dohme LLC is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Sandostatine® |
|---|---|
| Also known as | Octreotide acetate |
| Sponsor | Merck Sharp & Dohme LLC |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET (PHASE3)
- Intranasal Delivery of Octreotide for Treatment of Diabetic Macular Edema (PHASE1)
- 177Lu-DOTATATE for Recurrent Meningioma (PHASE2)
- Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients (PHASE3)
- Octreotide vs. Splenic Artery Ligation for Portal Flow Modulation in Living Donor Liver Transplants (SCALOP Trial) (PHASE4)
- Effects of Sandostatin LAR® in Acromegaly (PHASE4)
- Real-world Study on Adjuvant Octreotide Therapy in pNETs (NA)
- A Single-dose Study of Octreotide Injection in Healthy Adult Subjects (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Sandostatine® CI brief — competitive landscape report
- Sandostatine® updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI
Frequently asked questions about Sandostatine®
What is Sandostatine®?
Who makes Sandostatine®?
Is Sandostatine® also known as anything else?
What development phase is Sandostatine® in?
Related
- Manufacturer: Merck Sharp & Dohme LLC — full pipeline
- Also known as: Octreotide acetate
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing