- Trial Phase
- Approved
- Time to Market
- Already approved and marketed since 2008 (adults) and 2018 (pediatric). A potential label expansion for chemotherapy-induced thrombocytopenia (CIT) would require an FDA submission; no filing has been announced despite positive Phase 3 data published in March 2026.
- Why 4/10
- Nplate is an already-approved, marketed drug with no pending PDUFA date, no scheduled FDA Advisory Committee, and no announced pivotal topline readout in the next 12 months. The Phase 3 CIT trial (NCT03937154) has an estimated completion of May 2027 but no specific data release date. Without a hard, dated binary catalyst, the impact score defaults to 4 per the rubric for approved drugs.
Nplate has no hard, dated binary catalyst in the next 12 months. Watch for data from the ongoing Phase 3 CIT trial (NCT03937154, estimated completion May 2027) and for any FDA biosimilar approval or filing that could pressure the franchise. The Q3 2026 earnings showed steady 3% sales growth, and the drug remains a modest but stable contributor to Amgen's diversified revenue base.
Price Chart
Executive Summary
Nplate (romiplostim) is an FDA-approved thrombopoietin receptor agonist from Amgen (AMGN) that treats low platelet counts in immune thrombocytopenia (ITP) for adults (approved 2008) and children age 1+ (approved 2018). It generated approximately $1.5 billion in 2025 revenue (up ~4.7% YoY) and $472 million in Q3 2026 (up 3% YoY). Positive Phase 3 results for chemotherapy-induced thrombocytopenia were published in NEJM in March 2026, but no FDA submission for that indication has been announced. No biosimilar competition has reached the US market yet, though Adalvo acquired a romiplostim biosimilar program in October 2026. With no pending regulatory decision or hard binary catalyst, Nplate is a steady commercial product within Amgen's diversified portfolio rather than a stock-moving event driver.
How It Works
Nplate is a lab-made protein that mimics thrombopoietin, a natural hormone that tells the bone marrow to produce more platelets (the blood cells that help clotting). It is given as a weekly injection under the skin and works by binding to and activating the same receptor as the body's own platelet-regulating hormone, boosting platelet production in patients with immune thrombocytopenia (ITP), a condition where the immune system destroys platelets.
Trial Status
Nplate is FDA-approved and commercially marketed for immune thrombocytopenia (ITP). Two Phase 3 trials for chemotherapy-induced thrombocytopenia (CIT) have been conducted: one in GI/pancreatic/colorectal cancers (NCT03362177) is completed with positive results published in NEJM (March 2026); a second in NSCLC/ovarian/breast cancers (NCT03937154) is active but not recruiting, with estimated completion in May 2027.
The Two-Sided Case
Upcoming Catalysts
- Potential data readout from Phase 3 CIT trial NCT03937154 (estimated completion May 2027, no specific date announced)
- Any FDA biosimilar application filing or approval for romiplostim
- Possible FDA submission for CIT label expansion if Amgen pursues it
Source Filing
The SecBot filing or press-release report that triggered this drug report:
Amgen PRESS-RELEASE AMGN ·Originating report