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AZD9496 Variant A

AstraZeneca · Phase 1 active Small molecule ✓ Verified Jun 2026 Quality 40/100

AZD9496 Variant A is a Selective estrogen receptor degrader (SERD) Small molecule drug developed by AstraZeneca. It is currently in Phase 1 development.

AZD9496 Variant A selectively binds to and degrades estrogen receptors, blocking estrogen signaling in cancer cells.

AZD9496 Variant A is a variant of the experimental medication AZD9496, which is being studied in a clinical trial for breast cancer. The study, NCT02780713, is a Phase I trial that aims to evaluate the pharmacokinetic and safety profile of AZD9496 Variant A in healthy subjects.

Likelihood of approval
12.6% vs 9.6% industry baseline
If approved by FDA: likely 2033–2036
Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • 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
    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 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 nameAZD9496 Variant A
SponsorAstraZeneca
Drug classSelective estrogen receptor degrader (SERD)
ModalitySmall molecule
PhasePhase 1

Mechanism of action

AZD9496 is a selective estrogen receptor degrader (SERD) that binds to estrogen receptors and promotes their degradation. By eliminating estrogen receptors from cancer cells, it blocks estrogen-driven tumor growth. The oral formulation offers potential advantages over injectable SERDs.

Approved indications

Common side effects

No common side effects on file.

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 AZD9496 Variant A

What is AZD9496 Variant A?

AZD9496 Variant A is a Selective estrogen receptor degrader (SERD) drug developed by AstraZeneca.

How does AZD9496 Variant A work?

AZD9496 Variant A selectively binds to and degrades estrogen receptors, blocking estrogen signaling in cancer cells.

Who makes AZD9496 Variant A?

AZD9496 Variant A is developed by AstraZeneca (see full AstraZeneca pipeline at /company/astrazeneca).

What drug class is AZD9496 Variant A in?

AZD9496 Variant A belongs to the Selective estrogen receptor degrader (SERD) class. See all Selective estrogen receptor degrader (SERD) drugs at /class/selective-estrogen-receptor-degrader-serd.

What development phase is AZD9496 Variant A in?

AZD9496 Variant A is in Phase 1.

Related

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