Opd5
Multiple Myeloma, Relapse Multiple Myeloma
Phase I
Withdrawn
A Study of OPD5 Followed by Autologous Stem Cell Transplant for Patients With Relapsed Refractory Multiple Myeloma
May 27, 2021
―
Dexamethasone, Daratumumab, Melflufen
Relapsed Multiple Myeloma, Relapsed-Refractory Multiple Myeloma
Phase III
Terminated
Study of Melflufen (Melphalan Flufenamide) in Combination With Daratumumab in Relapsed-Refractory Multiple Myeloma
Nov 24, 2020
―
Dexamethasone, Melphalan
Rrmm
Phase II
Terminated
A PK, Safety and Tolerability Study of Peripheral and Central Infusion of Melflufen in RRMM Patients
May 18, 2020
―
Dexamethasone, Melphalan-Flufenamide (Melflufen)
Al Amyloidosis
Phase I
Terminated
A Clinical Study of Melphalan Flufenamide (Melflufen) and Dexamethasone for Patients With Immunoglobulin Light Chain (AL) Amyloidosis
Aug 29, 2019
―
Dexamethasone, Melflufen
Multiple Myeloma, Renal Impairment
Phase II
Terminated
PK of Melphalan During Treatment With Melflufen and Dexamethasone in Patients With RRMM and Impaired Renal Function
Aug 14, 2018
―
Dexamethasone, Daratumumab, Bortezomib, Melphalan Flufenamide (Melflufen)
Multiple Myeloma
Phase I/II
Terminated
Study of Melphalan Flufenamide (Melflufen) + Dex With Bortezomib or Daratumumab in Patients With RRMM
Mar 06, 2018
―
Dexamethasone, Pomalidomide, Melflufen
Multiple Myeloma
Phase III
Terminated
A Study of Melphalan Flufenamide (Melflufen)-Dex or Pomalidomide-dex for RRMM Patients Refractory to Lenalidomide
May 09, 2017
―
Dexamethasone, Melphalan Flufenamide (Melflufen)
Multiple Myeloma
Phase II
Completed
A Study of Melphalan Flufenamide (Melflufen) Plus Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
Oct 18, 2016
―
Dexamethasone, Melflufen
Relapsed And/Or Relapsed-Refractory Multiple Myeloma
Phase I/II
Terminated
Safety and Efficacy of Melflufen and Dexamethasone in Relapsed and/or Relapsed-Refractory Multiple Myeloma Patients
Jul 09, 2013
―
FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Oncopeptides AB (OND) have in its pipeline
OND is currently developing the following drugs: Opd5, Dexamethasone, Daratumumab, Melflufen, Dexamethasone, Melphalan. These drug candidates are in various stages of clinical development as the company works toward FDA approval.