HYCAMTIN (topotecan hydrochloride)
HYCAMTIN is indicated for the treatment of Small Cell Lung Cancer.
How HYCAMTIN Works
Topotecan is a topoisomerase I inhibitor. It stabilizes the covalent complex of topoisomerase I and DNA, which normally induces reversible single-strand breaks to relieve torsional strain. By binding to this complex, topotecan prevents the re-ligation of the DNA strands. During DNA synthesis, replication enzymes collide with these ternary complexes, resulting in permanent double-strand DNA damage and subsequent cell death.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1996-05-28
- Routes
- ORAL, INJECTION
- Dosage Forms
- CAPSULE, INJECTABLE
HYCAMTIN Approval History
What HYCAMTIN Treats
1 indicationsHYCAMTIN is approved for 1 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Small Cell Lung Cancer
HYCAMTIN Boxed Warning
MYELOSUPPRESSION HYCAMTIN can cause severe myelosuppression. Administer first cycle only to patients with baseline neutrophil counts of greater than or equal to 1,500/mm 3 and platelet counts greater than or equal to 100,000/mm 3 . Monitor blood cell counts [see Warnings and Precautions (5.1)] . WARNING: MYELOSUPPRESSION See full prescribing information for complete boxed warning. HYCAMTIN can cause severe myelosuppression. Administer first cycle only to patients with baseline neutrophil counts ...
WARNING: MYELOSUPPRESSION HYCAMTIN can cause severe myelosuppression. Administer first cycle only to patients with baseline neutrophil counts of greater than or equal to 1,500/mm 3 and platelet counts greater than or equal to 100,000/mm 3 . Monitor blood cell counts [see Warnings and Precautions (5.1)] . WARNING: MYELOSUPPRESSION See full prescribing information for complete boxed warning. HYCAMTIN can cause severe myelosuppression. Administer first cycle only to patients with baseline neutrophil counts of greater than or equal to 1,500/mm 3 and platelet counts of greater than or equal to 100,000/mm 3 . Monitor blood cell counts ( 2.2 , 5.1 ).
HYCAMTIN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in HYCAMTIN's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications HYCAMTIN treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to HYCAMTIN
3 of 8FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
30 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05353439 | NCI-2022-03215 NCI-2022-03215, 22-C-0005 | Ph 1 | active not recruiting | Testing of Tazemetostat in Combination With Topotecan and Pembrolizumab in Patients With Recurrent Small Cell Lung Cancer |
| NCT02502266 results posted | NCI-2015-00651 NCI-2015-00651, NRG-GY005 | Ph 2, Ph 3 | active not recruiting | Testing the Combination of Cediranib and Olaparib in Comparison to Each Drug Alone or Other Chemotherapy in Recurrent Platinum-Resistant Ovarian Cancer |
| NCT01012817 results posted | NCI-2011-00312 NCI-2011-00312, 09-000742 | Ph 1, Ph 2 | active not recruiting | Veliparib and Topotecan Hydrochloride in Treating Patients With Solid Tumors, Relapsed or Refractory Ovarian Cancer, or Primary Peritoneal Cancer |
| NCT03289910 results posted | NCI-2017-01715 NCI-2017-01715, ETCTN10147 | Ph 2 | active not recruiting | Topotecan Hydrochloride and Carboplatin With or Without Veliparib in Treating Advanced Myeloproliferative Disorders and Acute Myeloid Leukemia or Chronic Myelomonocytic Leukemia |
| NCT03896503 results posted | NCI-2019-01769 NCI-2019-01769, 20-C-0009 | Ph 2 | active not recruiting | Randomized Trial of Topotecan With M6620, an ATR Kinase Inhibitor, in Small Cell Lung Cancers and Small Cell Cancers Outside of the Lungs |
| NCT04739800 results posted | NCI-2021-00615 NCI-2021-00615, NRG-GY023 | Ph 2 | active not recruiting | Comparison of Standard of Care Treatment With a Triplet Combination of Targeted Immunotherapeutic Agents |
| NCT03126916 | ANBL1531 NCI-2016-01734, ANBL1531 | Ph 3 | recruiting | Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL) |
| NCT01175356 results posted | ANBL09P1 NCI-2011-01745, ANBL09P1 | Ph 1 | completed | Induction Therapy Including 131 I-MIBG and Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma Undergoing Stem Cell Transplant, Radiation Therapy, and Maintenance Therapy With Isotretinoin |
| NCT01231906 results posted | AEWS1031 NCI-2011-02611, S12-01231 | Ph 3 | completed | Combination Chemotherapy in Treating Patients With Non-Metastatic Extracranial Ewing Sarcoma |
| NCT02364713 results posted | MC1365 NCI-2015-00133, MC1365 | Ph 2 | terminated | MV-NIS or Investigator's Choice Chemotherapy in Treating Patients With Ovarian, Fallopian, or Peritoneal Cancer |
| NCT02569957 results posted | 15P.404 JT 7408 | Ph 2 | terminated | Effect of Acetylcysteine With Topotecan Hydrochloride on the Tumor Microenvironment in Patients With Persistent or Recurrent High Grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer |
| NCT00588991 | NCI-2009-00259 NCI-2009-00259, CDR0000579626 | Ph 1 | completed | Veliparib and Topotecan With or Without Carboplatin in Treating Patients With Relapsed or Refractory Acute Leukemia, High-Risk Myelodysplasia, or Aggressive Myeloproliferative Disorders |
| NCT04514497 results posted | NCI-2020-05958 NCI-2020-05958, 10402 | Ph 1 | active not recruiting | Testing the Addition of an Anti-cancer Drug, BAY 1895344, to Usual Chemotherapy for Advanced Stage Solid Tumors, With a Specific Focus on Patients With Small Cell Lung Cancer, Poorly Differentiated Neuroendocrine Cancer, and Pancreatic Cancer |
| NCT02312245 results posted | MC1463 NCI-2014-02399, 14-002986 | Ph 2 | completed | Avatar-Directed Chemotherapy in Treating Patients With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer |
| NCT01798004 results posted | ANBL12P1 NCI-2012-02211, ANBL12P1 | Ph 1 | completed | Busulfan, Melphalan, and Stem Cell Transplant After Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma |
| NCT01606878 results posted | ADVL1212 NCI-2012-01968, CDR0000734059 | Ph 1 | completed | Crizotinib and Combination Chemotherapy in Treating Younger Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma |
| NCT05295589 | NCI-2022-02228 NCI-2022-02228, NRG-GY029 | Ph 2 | withdrawn | Comparing Standard of Care Chemotherapy Treatment to the Combination of Copanlisib and Olaparib for Recurrent Platinum Resistant Ovarian Cancer That Has Progressed Through PARP Inhibitor Therapy |
| NCT00856037 | 0508-08-FB NCI-2009-01308, P30CA036727 | Ph 1 | completed | Topotecan Hydrochloride and Doxorubicin Hydrochloride in Treating Relapsed or Refractory Small Cell Lung Cancer |
| NCT01803269 results posted | 12-1726 NCI-2013-00402 | Ph 2 | terminated | Topotecan Hydrochloride or Cyclodextrin-Based Polymer-Camptothecin CRLX101 in Treating Patients With Recurrent Small Cell Lung Cancer |
| NCT01266447 results posted | NCI-2011-02659 NCI-2011-02659, GOG-0127W | Ph 2 | completed | Veliparib, Topotecan Hydrochloride, and Filgrastim or Pegfilgrastim in Treating Patients With Persistent or Recurrent Cervical Cancer |
| NCT00803062 results posted | NCI-2009-01084 NCI-2009-01084, CDR0000628746 | Ph 3 | completed | Paclitaxel and Cisplatin or Topotecan With or Without Bevacizumab in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer |
| NCT01654965 | NCI-2012-01220 NCI-2012-01220, CDR0000738072 | Ph 1 | completed | Tivantinib and Topotecan Hydrochloride in Treating Patients With Advanced or Metastatic Solid Tumors |
| NCT00828139 results posted | NCI-2009-01182 NCI-2009-01182, SWOG-S0802 | Ph 2 | completed | S0802 - Topotecan With or Without Aflibercept in Treating Patients With Extensive-Stage Small Cell Lung Cancer |
| NCT00960739 MIITOP | MIITOP-0607 | Ph 2 | completed | Iodobenzylguanidine Meta-I131 and Topotecan in Young Patients With Refractory or Relapsed Metastatic Neuroblastoma |
| NCT01533181 results posted | NCI-2012-00245 NCI-2012-00245, CDR0000724806 | Ph 2 | completed | Linsitinib or Topotecan Hydrochloride in Treating Patients With Relapsed Small Cell Lung Cancer |
| NCT00634244 results posted | NCI-2009-00520 NCI-2009-00520, E1906 | Ph 2 | completed | Comparing Three Different Combination Chemotherapy Regimens in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia |
| NCT00807079 | CDR0000626790 ARCAGY-GINECO-CE102, ARCAGY-HYCAR | Ph 1, Ph 2 | completed | Carboplatin and Topotecan in Treating Patients With Relapsed or Metastatic Cervical Cancer |
| NCT00516295 results posted | NCI-2009-00369 NCI-2009-00369, AEWS0521 | Ph 2 | completed | Vincristine Sulfate, Topotecan Hydrochloride, and Cyclophosphamide With or Without Bevacizumab in Treating Young Patients With Refractory or First Recurrent Extracranial Ewing Sarcoma |
| NCT00389766 | CCLG-NB-2006-08 CDR0000508611, EU-20644 | Ph 2 | withdrawn | High-Dose Iodine I 131 Metaiodobenzylguanidine, Topotecan, and Peripheral Stem Cell Transplant in Treating Young Patients With Relapsed Stage 4 Neuroblastoma or Primary Resistant High-Risk Neuroblastoma |
| NCT00842452 | CASE2Y08 P30CA043703, CASE2Y08 | Ph 1 | completed | Topotecan in Treating Patients With Gynecologic Cancer That Cannot Be Removed by Surgery |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
HYCAMTIN FDA Label Details
Indications & Usage
FDA Label (PDF)HYCAMTIN is indicated for the treatment of Small Cell Lung Cancer.
WARNING: MYELOSUPPRESSION HYCAMTIN can cause severe myelosuppression. Administer first cycle only to patients with baseline neutrophil counts of greater than or equal to 1,500/mm 3 and platelet counts greater than or equal to 100,000/mm 3 . Monitor blood cell counts [see Warnings and Precautions (5....
Track HYCAMTIN with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment