Debio 025

Phase 3Small molecule

DDebiopharm International SA

Debio 025 is one of 151 small molecule programs targeting Central precocious puberty. It is currently in Phase 3.

Indications

Total Trials

Active Trials

150

Competitors

Pipeline

Status by Indication[3][1]

Indication

Central Precocious PubertyActive, not recruiting

Chronic HepatitisActive, not recruiting

Acute Myeloid LeukemiaRecruiting

Small Cell Lung CancerActive, not recruiting

Glioblastoma IDH (isocitrate Dehydrogenase) WildtypeRecruiting

Central Precocious PubertyPhase 3

Active, not recruiting

Chronic HepatitisPreclinical

Active, not recruiting

Acute Myeloid LeukemiaPhase 2

Recruiting

Small Cell Lung CancerPhase 1

Active, not recruiting

Glioblastoma IDH (isocitrate Dehydrogenase) WildtypePreclinical

Recruiting

Competition

Competitive Landscape

235 competitors in Acute Myeloid Leukemia

#DrugCompanyPhaseTrials

Idamycin

Pfizer

Phase 3

60 2

Novantrone

Pfizer

Phase 3

34 3

Xospata

Astellas

Phase 3

24 4

Vepesid

AAvyxa

Phase 3

52 5

Cerubidine

HHikma Pharmaceuticals LLC

Phase 3

42 6

Mylotarg

WWyeth-Lederle Vaccines

Phase 3

38 7

Cerubidine

HHikma Pharmaceuticals LLC

Phase 3

32 8

Neupogen

EEastern Cooperative Oncology Group

Phase 3

30 9

Cellcept

Busulfex

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2028

Phase 3Active, not recruiting

Central Precocious Puberty

NCT06129539

Q3 2028

PreclinicalRecruiting

Glioblastoma IDH (isocitrate Dehydrogenase) Wildtype

NCT05765812

Q1 2029

Phase 3Recruiting

Acromegaly

NCT06930625

Q4 2031

PreclinicalRecruiting

Acute Myeloid Leukemia

NCT06969430

Clinical

Trials by Indication[1]

Advanced Solid Tumors2 trials

Study of Oral Debio 0123 in Combination With Carboplatin in Participants With Advanced Solid Tumors

Terminated·DDebiopharm International SA·Phase 1·NCT03968653·76 enrolled

A Phase 1, Dose-finding Study of Debio 0123 as Monotherapy in Adult Patients With Advanced Solid Tumors, Followed by an Expansion Part to Assess Safety and Preliminary Anti-tumor Activity

Terminated·DDebiopharm International SA·Phase 1·NCT05109975·93 enrolled

Lymphoma2 trials

Dose Escalation Study of Safety and Tolerability of AT-406 in Patients With Advanced Solid Tumors and Lymphomas

Completed·DDebiopharm International SA·Phase 1·NCT01078649·51 enrolled

Study of Debio 0932 in Patients With Advanced Solid Tumours or Lymphoma

Completed·DDebiopharm International SA·Phase 1·NCT01168752·81 enrolled

Non-Small Cell Lung Cancer2 trials

A Dose-Finding Study of the Second Mitochondrial Activator of Caspases (SMAC) Mimetic Debio 1143 When Given in Combination With Avelumab to Participants With Advanced Solid Malignancies and to Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) After Platinum-Based Therapy

Completed·DDebiopharm International SA·Phase 1·NCT03270176·54 enrolled

A Clinical Study on the Safety and Efficacy of Debio 0932 in Combination With Standard of Care in Patients With Non-small Cell Lung Cancer [NSCLC]

Terminated·DDebiopharm International SA·Phase 1·NCT01714037·82 enrolled

Hip Replacement Surgery1 trial

Drug Penetration Into Bone After Repeated Oral Administration of Debio 1450 to Patients Undergoing Hip Replacement Surgery

Completed·DDebiopharm International SA·Phase 1·NCT02726438·17 enrolled

Skin Infection1 trial

Study of Debio 1450 for Bacterial Skin Infections

Completed·DDebiopharm International SA·Phase 2·NCT02426918·330 enrolled

16 more indications

Refractory1 trial

Study to Evaluate the Efficacy and Tolerability of Debio 1562 in Combination With Rituximab in Participants With Relapsed and/or Refractory DLBCL and Other Forms of NHL

Completed·DDebiopharm International SA·Phase 2·NCT02564744·100 enrolled

Safety and Efficacy1 trial

Study to Assess Safety and Efficacy of the Second Mitochondrial-derived Activator of Caspases (SMAC) Mimetic Debio 1143

Completed·DDebiopharm International SA·Phase 1/2·NCT04122625·46 enrolled

Chronic Hepatitis1 trial

A Study of Debio 025 (Alisporivir) Combined With Peg-IFNα2a and Ribavirin in Treatment naïve Chronic Hepatitis C Genotype 1 Patients

Completed·DDebiopharm International SA·N/A·NCT00854802·290 enrolled

Treatment1 trial

A Study of Debio 025 in Combination With PegIFN Alpha-2a and Ribavirin in Chronic HCV Patients Non-responders to Standard Treatment

Completed·DDebiopharm International SA·Phase 2·NCT00537407·50 enrolled

Single Dose1 trial

A Single Dose Study of Debio 1450 in Healthy Subjects

Completed·DDebiopharm International SA·Phase 1·NCT02162199·48 enrolled

Intravenous1 trial

A Multiple Dose Study of Debio 1450 [Intravenous (IV) and Oral] in Healthy Volunteers

Completed·DDebiopharm International SA·Phase 1·NCT02214433·70 enrolled

Small Cell Lung Cancer1 trial

Debio 0123 in Combination With Carboplatin and Etoposide in Adult Participants With Small Cell Lung Cancer That Recurred or Progressed After Previous Standard Platinum-Based Therapy

Active, not recruiting·DDebiopharm International SA·Phase 1·NCT05815160·34 enrolled

Tics1 trial

A Study to Investigate the Effect of Itraconazole on the Pharmacokinetics of Debio 1450 in Healthy Subjects

Completed·DDebiopharm International SA·Phase 1·NCT03209648·20 enrolled

Pancreatic Neuroendocrine Tumor1 trial

A Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Debio 4126 in Participants With Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)

Terminated·DDebiopharm International SA·Phase 1·NCT05364944·19 enrolled

Efficacy1 trial

Debio 1143-201 Dose-finding and Efficacy Phase I/II Trial

Completed·DDebiopharm International SA·N/A·NCT02022098·144 enrolled

Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype1 trial

A Phase 1/2 Open-label Study of Debio 0123 in Combination With Temozolomide in Adult Participants With Recurrent or Progressive Glioblastoma and of Debio 0123 in Combination With Temozolomide and Radiotherapy in Adult Participants With Newly Diagnosed Glioblastoma

Recruiting·DDebiopharm International SA·Preclinical·NCT05765812·116 enrolled

Central precocious puberty1 trial

LIBELULA™: An Open-label, Single-arm, Multi-center, Phase 3 Study on the Efficacy, Safety, and Pharmacokinetics of Debio 4326, a Triptorelin 12-month Formulation, in Pediatric Participants With Central Precocious Puberty

Active, not recruiting·DDebiopharm International SA·Phase 3·NCT06129539·56 enrolled

Acute Myeloid Leukemia1 trial

A Phase 1/2, First-in-human, Multicenter, Open-label Trial Evaluating the Safety, Tolerability, and Antileukemic Activity of Debio 1562M in Participants With Acute Myeloid Leukemia (AML)

Recruiting·DDebiopharm International SA·Preclinical·NCT06969430·154 enrolled

Acromegaly1 trial

A Phase 3 Randomized 3-arm Trial (Double-blind Debio 4126, Placebo Control, and Open-label Debio 4126), to Assess the Efficacy and Safety of Debio 4126, a 12-week Octreotide Formulation, in Patients With Acromegaly Previously Treated With Somatostatin Analogs

Recruiting·DDebiopharm International SA·Phase 3·NCT06930625·119 enrolled

Prostate Cancer1 trial

A Phase 2, Randomized, Open-Label, Dose-Finding Study of Debio 4228, an Extended-Release Formulation of Gonadotropin-Releasing Hormone Antagonist in Participants With Advanced Prostate Cancer

Completed·DDebiopharm International SA·Phase 2·NCT06395753·55 enrolled

Unspecified1 trial

A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of Debio 1453P in Healthy Adults

Recruiting·DDebiopharm International SA·Phase 1·NCT07035769·88 enrolled

Sources

References

[1]
ClinicalTrials.gov — 24 trial records for Debio 025. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Debio 025 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Debio 025. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Debiopharm International SA company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: DDebiopharm International SA

Debio 025

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2028

Q3 2028

Q1 2029

Q4 2031

Trials by Indication[1]

Advanced Solid Tumors2 trials

Lymphoma2 trials

Non-Small Cell Lung Cancer2 trials

Hip Replacement Surgery1 trial

Skin Infection1 trial

Refractory1 trial

Safety and Efficacy1 trial

Chronic Hepatitis1 trial

Treatment1 trial

Single Dose1 trial

Intravenous1 trial

Small Cell Lung Cancer1 trial

Tics1 trial

Pancreatic Neuroendocrine Tumor1 trial

Efficacy1 trial

Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype1 trial

Central precocious puberty1 trial

Acute Myeloid Leukemia1 trial

Acromegaly1 trial

Prostate Cancer1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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