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Gemcitabine - 21 day cycle — Competitive Intelligence Brief

Gemcitabine - 21 day cycle (Gemcitabine - 21 day cycle) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Nucleoside analog. Area: Oncology.

phase 2 Nucleoside analog Ribonucleotide reductase Oncology Small molecule Live · refreshed every 30 min

Target snapshot

Gemcitabine - 21 day cycle (Gemcitabine - 21 day cycle) — Actuate Therapeutics Inc.. Inhibits DNA synthesis by inhibiting ribonucleotide reductase and DNA polymerase alpha

Comparator set (6 drugs)

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DrugGenericSponsorPhaseClassTargetApproval / PDUFA
Gemcitabine - 21 day cycle TARGET Gemcitabine - 21 day cycle Actuate Therapeutics Inc. phase 2 Nucleoside analog Ribonucleotide reductase
Gemzar Gemcitabine Hydrochloride Accord Hlthcare marketed Nucleoside metabolic inhibitor Ribonucleotide reductase; DNA incorporation 1996-01-01
HYDROXYUREA HYDROXYUREA marketed Antimetabolite [EPC] Ribonucleotide reductase 1967-01-01
Fludarabine (FLU) Fludarabine (FLU) Nanfang Hospital, Southern Medical University marketed Purine nucleoside analog Ribonucleotide reductase, DNA polymerase
Platinum + Gemcitabine Platinum + Gemcitabine Fondazione Policlinico Universitario Agostino Gemelli IRCCS marketed Chemotherapy combination (platinum agent + nucleoside analog) DNA (platinum crosslinking); ribonucleotide reductase and DNA polymerase (gemcitabine)
standard dose ARA-C standard dose ARA-C National Research Center for Hematology, Russia marketed Nucleoside analog antimetabolite DNA polymerase; ribonucleotide reductase
Gemcitabine (GEM) Gemcitabine (GEM) Sun Yat-sen University marketed Nucleoside analog; antimetabolite Ribonucleotide reductase; DNA polymerase

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

Sponsor landscape (Nucleoside analog class)

  1. Third Affiliated Hospital, Sun Yat-Sen University · 2 drugs in this class
  2. Actuate Therapeutics Inc. · 2 drugs in this class
  3. City of Hope Medical Center · 1 drug in this class
  4. Cooperative Study Group A for Hematology · 1 drug in this class
  5. Genzyme, a Sanofi Company · 1 drug in this class
  6. Hospices Civils de Lyon · 1 drug in this class
  7. Innovent Biologics (Suzhou) Co. Ltd. · 1 drug in this class
  8. Osaka Medical Center for Cancer and Cardiovascular Diseases · 1 drug in this class
  9. Tanabe Pharma Corporation · 1 drug in this class
  10. The Methodist Hospital Research Institute · 1 drug in this class

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Cite this brief

Drug Landscape (2026). Gemcitabine - 21 day cycle — Competitive Intelligence Brief. https://druglandscape.com/ci/gemcitabine-21-day-cycle. Accessed 2026-05-16.

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