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NCE-1 Intelligence & Market Opportunity

Revtorpyk

Gedatolisib
PI3K/AKT/mTOR (PAM) Inhibitor
Intravenous Powder

Hormone receptor-positive, HER2-negative breast cancer remains challenging once resistance to endocrine therapy develops. Revtorpyk (gedatolisib) introduces another targeted option by blocking the PI3K/AKT/mTOR (PAM) pathway, one of the key drivers of tumor growth and treatment resistance.

Approved by the FDA in combination with fulvestrant, Revtorpyk is indicated for patients with locally advanced or metastatic disease following endocrine therapy. Unlike many pathway-directed therapies that focus only on patients with a PIK3CA mutation, Revtorpyk expands treatment possibilities for those without that mutation.

With its unique positioning, Revtorpyk is expected to attract attention in future oncology studies. Monitoring its market performance, exclusivity, and sourcing availability will be increasingly relevant for clinical trial teams and companies evaluating future filing opportunities.

Approval Date
14-Jul-26
NCE-1 Date
14-Jul-30
NCE Date
14-Jul-31
Commercial snapshot

Market performance & projections

Revenue ($M)
NA
CAGR (%)
NA
Projected sales, 2026–2032 ($M)
Analyst projection, $M per year
2026
44
2027
349
2028
625
2029
903
2030
1229
2031
1668
2032
2056
Molecule profile

Details & specifications

Molecule
Gedatolisib
Innovator
CELCUITY INC
Dosage Form
Intravenous Powder
Strength
180 mg/vial
Therapeutic Category
PI3K/AKT/mTOR (PAM) Inhibitor
Usage
With fulvestrant, to treat HR-positive, HER2-negative, locally advanced or metastatic breast cancer without PIK3CA mutation after endocrine therapy
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Intelligence you can file on

Verified regulatory data
Milestones tracked against primary FDA sources and refreshed continuously.
Analyst-built projections
Seven-year sales outlooks modeled by our pharma intelligence team.
First-to-file focus
Exclusivity windows framed around the decisions generics teams actually make.
Partnership on demand
From API sourcing to dossier support — one request starts the conversation.

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