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Placebo + insulin

AstraZeneca · Phase 3 active Small molecule Under review Quality 0/100

Placebo + insulin is a Hormone Small molecule drug developed by AstraZeneca. It is currently in Phase 3 development for Type 1 diabetes, Type 2 diabetes.

Insulin works by lowering blood sugar levels by stimulating glucose uptake in cells.

Saizen, an insulin receptor agonist, has been studied in clinical trials for various conditions including fibromyalgia, type 2 diabetes, and prediabetes. The mechanism of Saizen involves activating the insulin receptor, a protein target.

Likelihood of approval
61.3% vs 58.3% industry baseline
If approved by FDA: likely 2028–2030
Steps remaining: NDA/BLA submission
Confidence: High
Why this estimate
  • Baseline phase 3 → approval rate +58.3pp
    Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
  • Big-pharma sponsor +3.0pp
    AstraZeneca is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2028–2030 —
EMA EU 2029–2031 +0.7 yr
MHRA GB 2029–2031 +0.7 yr
Health Canada CA 2029–2032 +0.9 yr
TGA AU 2029–2032 +1.2 yr
PMDA JP 2029–2032 +1.5 yr
NMPA CN 2030–2033 +2.3 yr
MFDS KR 2029–2032 +1.4 yr
CDSCO IN 2029–2033 +1.8 yr
ANVISA BR 2030–2033 +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 namePlacebo + insulin
SponsorAstraZeneca
Drug classHormone
TargetInsulin receptor
ModalitySmall molecule
Therapeutic areaDiabetes
PhasePhase 3

Mechanism of action

Insulin is a hormone that plays a crucial role in glucose regulation. It binds to its receptor on the surface of cells, triggering a signaling cascade that ultimately leads to the uptake of glucose from the bloodstream into cells.

Approved indications

Common side effects

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Placebo + insulin

What is Placebo + insulin?

Placebo + insulin is a Hormone drug developed by AstraZeneca, indicated for Type 1 diabetes, Type 2 diabetes.

How does Placebo + insulin work?

Insulin works by lowering blood sugar levels by stimulating glucose uptake in cells.

What is Placebo + insulin used for?

Placebo + insulin is indicated for Type 1 diabetes, Type 2 diabetes.

Who makes Placebo + insulin?

Placebo + insulin is developed by AstraZeneca (see full AstraZeneca pipeline at /company/astrazeneca).

What drug class is Placebo + insulin in?

Placebo + insulin belongs to the Hormone class. See all Hormone drugs at /class/hormone.

What development phase is Placebo + insulin in?

Placebo + insulin is in Phase 3.

What are the side effects of Placebo + insulin?

Common side effects of Placebo + insulin include Hypoglycemia, Weight gain, Allergic reactions.

What does Placebo + insulin target?

Placebo + insulin targets Insulin receptor and is a Hormone.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing