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Bending the Curve Trial by Trial
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Anthracyclines and anthracenedionesIn useNatural product

Daunorubicin

Also known as Daunomycin, Rubidomycin, Cerubidine

An anthracycline antibiotic given by injection. Its US generic label lists remission induction, with other anticancer drugs, in acute nonlymphocytic leukaemia in adults and acute lymphocytic leukaemia in children and adults.

From discovery to approval

  1. 1963 · First described

    A May 1963 paper by Di Marco and colleagues in Tumori described daunomycin as a new antibiotic isolated from cultures of Streptomyces peucetius that inhibited 10 of 12 animal tumours tested. A French group's 1963 note named an antibiotic rubidomycin; the title of a 1967 paper states that rubidomycin and daunomycin are identical.[2][3][4][5][6][7][8][1]

  2. 1979-12-19 · FDA regular · 16 years after first description

    Daunorubicin hydrochloride injection (Cerubidine), NDA 050484, original approval, classed as a new molecular entity with priority review in the Drugs@FDA history. The original label and letter are not available there, so the indication at approval is not stated here; the current generic label lists remission induction in acute nonlymphocytic and acute lymphocytic leukaemia. The type regular is an inference: no accelerated-approval wording was found.[9]

How it works

Forms complexes with DNA by intercalating between base pairs and inhibits topoisomerase II by stabilising the DNA-topoisomerase II complex, which prevents re-ligation and leaves single and double strand breaks. The label says it may also inhibit polymerase activity, affect gene expression and cause free radical damage to DNA.[1]

Where it came from and why

Cassinelli's review says a May 1960 agreement between the company Farmitalia and the Istituto Nazionale dei Tumori in Milan set out to find and develop new natural antitumour agents up to clinical trials, and daunomycin came from that programme. A 1977 review notes that anthracycline pigments from Streptomyces were known earlier, from Brockmann's rhodomycins in 1951.

In May 1960 the company Farmitalia and the Istituto Nazionale dei Tumori of Milan signed an agreement to find and develop new natural antitumour agents up to clinical trials [6]. Cassinelli's review credits a Streptomyces found near Castel del Monte in Apulia, and says daunomycin was ready for clinical trials within three years [6].

In 1963 Di Marco and colleagues described daunomycin as a new antibiotic isolated from cultures of Streptomyces peucetius, with significant inhibition of 10 of 12 tumours tested in animals [2]. A Nature paper followed in 1964, titled as describing a new antibiotic of the rhodomycin group [3]. A French group had reported a cytostatic antibiotic called rubidomycin in 1963 [4], and a 1967 paper by Despois and colleagues is titled as showing that rubidomycin and daunomycin are identical [5]. According to Cassinelli, a patent interference involving Farmitalia's French partner was overcome, and cooperation between Di Marco and Karnofsky of the Sloan-Kettering Cancer Institute led to the first transatlantic clinical trials [6].

The producing organism is not named consistently: the 1963 paper names Streptomyces peucetius [2], while the US label describes the drug as produced by a strain of Streptomyces coeruleorubidus [1]. In 1967 Tan, Karnofsky and colleagues published a clinical evaluation with special reference to childhood leukaemia [8].

Cancers

  • Acute nonlymphocytic leukaemia

    The US generic label lists remission induction, in combination with other approved anticancer drugs, in acute nonlymphocytic leukaemia (myelogenous, monocytic, erythroid) in adults.[1]

  • Acute lymphocytic leukaemia

    The same label lists remission induction, with other approved anticancer drugs, in acute lymphocytic leukaemia in children and adults.[1]

  • Acute myelocytic leukaemia (with cytarabine)

    A randomised CALGB comparison with a 7-day cytarabine infusion reported complete remission in 72%, 59% and 58% of patients under 60 given daunorubicin 45 mg/m2, daunorubicin 30 mg/m2 and adriamycin 30 mg/m2.[10]

Family and partners

Drugs derived from it: Doxorubicin, Epirubicin, Idarubicin

Worth knowing

  • The US generic label warns that the incidence of myocardial toxicity increases after a total cumulative dose exceeding 400 to 550 mg/m2 in adults, 300 mg/m2 in children older than 2 years or 10 mg/kg in children younger than 2 years.[1]
  • A 2013 review dates the '7+3' regimen, 7 days of continuous cytarabine with daunorubicin on the first 3 days, to 1973.[11]
  • The US label describes daunorubicin as an anthracycline antibiotic produced by a strain of Streptomyces coeruleorubidus.[1]
  • A 1981 review by Di Marco and colleagues states that the relationship between a compound's affinity for DNA and its biological activity was first recorded for daunorubicin.[12]
  • A liposomal combination of daunorubicin and cytarabine (Vyxeos) is listed in its 2026 US label for newly diagnosed therapy-related acute myeloid leukaemia or AML with myelodysplasia-related changes, in adults and children aged 1 year and older.[13]

On this site

References

  1. Hikma Pharmaceuticals USA Inc. Daunorubicin hydrochloride injection: prescribing information (revised March 2020). DailyMed, set ID 227784a8-ce68-4dd4-8ac5-a65265969677, published 16 February 2024. Source
  2. Di Marco A, Gaetani M, Dorigotti L, Soldati M, Bellini O. Daunomycin: a new antibiotic with antitumor activity. Tumori. 1963;49(3):203-17. DOI
  3. DIMARCO A, GAETANI M, OREZZI P, SCARPINATO BM, SILVESTRINI R, SOLDATI M, et al. 'DAUNOMYCIN', A NEW ANTIBIOTIC OF THE RHODOMYCIN GROUP. Nature. 1964;201:706-7. PubMedDOI
  4. DUBOST M, GANTER P, MARAL R, NINET L, PINNERT S, PREUDHOMME J, et al. [A NEW ANTIBIOTIC WITH CYTOSTATIC PROPERTIES: RUBIDOMYCIN]. C R Hebd Seances Acad Sci. 1963;257:1813-5. PubMed
  5. Despois R, Dubost M, Mancy D, Maral R, Ninet L, Pinnert S, et al. [Isolation of a new antibiotic with antitumor activity: rubidomycin (l3,057 R.P.). Identity of rubidomycin and daunomycin]. Pathol Biol. 1967;15(19):887-91. PubMed
  6. Cassinelli G. The roots of modern oncology: from discovery of new antitumor anthracyclines to their clinical use. Tumori. 2016;2016(3):226-35. PubMedDOI
  7. Oki T. New anthracycline antibiotics. Jpn J Antibiot. 1977;30 Suppl:70-84. PubMed
  8. Tan C, Tasaka H, Yu KP, Murphy ML, Karnofsky DA. Daunomycin, an antitumor antibiotic, in the treatment of neoplastic disease. Clinical evaluation with special reference to childhood leukemia. Cancer. 1967;20(3):333-53. PubMedDOI
  9. U.S. Food and Drug Administration. Drugs@FDA: Approval date(s) and history, letters, labels, reviews for NDA 050484 (Cerubidine, daunorubicin hydrochloride). Page read 2026-10-29. Source
  10. Yates J, Glidewell O, Wiernik P, Cooper MR, Steinberg D, Dosik H, et al. Cytosine arabinoside with daunorubicin or adriamycin for therapy of acute myelocytic leukemia: a CALGB study. Blood. 1982;60(2):454-62. PubMed
  11. Lichtman MA. A historical perspective on the development of the cytarabine (7days) and daunorubicin (3days) treatment regimen for acute myelogenous leukemia: 2013 the 40th anniversary of 7+3. Blood Cells Mol Dis. 2013;50(2):119-30. PubMedDOI
  12. Di Marco A, Cassinelli G, Arcamone F. The discovery of daunorubicin. Cancer Treat Rep. 1981;65 Suppl 4:3-8. PubMed
  13. Jazz Pharmaceuticals, Inc. Vyxeos (daunorubicin and cytarabine) liposome for injection: prescribing information. DailyMed, set ID 7ea701ce-e7d3-4349-a9c2-642a501d45c8, published 9 February 2026. Source