Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

Remestemcel-L - Mesoblast

Next Previous
X
Search
Drug Profile

Remestemcel-L - Mesoblast

Alternative Names: hMSC - Mesoblast; human mesenchymal stem cells - Mesoblast; JR-0301; JR-031; JR-031 HIE; JR-031EB; MSC-100; MSC-100-IV; OTI-010; OTI-020; OTI-021; Prochymal; Provacel; RYONCIL; Stromagen; TEMCELL HS Inj.

Latest Information Update: 02 Aug 2024

Price :

$50 *

Note:
  • Adis is an information provider. We do not sell or distribute actual drugs.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our drug profile at the time of purchase.
  • A link to download a PDF version of the drug profile will be included in your email receipt.

At a glance

  • Originator Osiris Therapeutics
  • Developer Cleveland Clinic; JCR Pharmaceuticals; Mesoblast; Osaka University; Osiris Therapeutics
  • Class Mesenchymal stem cell therapies
  • Mechanism of Action Cell replacements
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Graft-versus-host disease; Type 1 diabetes mellitus; Epidermolysis bullosa
  • New Molecular Entity No

Highest Development Phases

  • Marketed Graft-versus-host disease
  • Preregistration Epidermolysis bullosa
  • Phase III Back pain; Crohn's disease; Myocardial infarction; SARS-CoV-2 acute respiratory disease
  • Phase I/II Brain hypoxia-ischaemia; Ulcerative colitis
  • Discontinued Acute radiation syndrome; Chronic obstructive pulmonary disease; Type 1 diabetes mellitus

Most Recent Events

  • 31 Jul 2024 FDA assigns PDUFA action date of 7/1/2025 for remestemcel-L for Graft-versus-host disease (In Children, Treatment-experienced)
  • 30 Jul 2024 Mesoblast plans to launch remestemcel-L for Graft versus Host Disease (In children) in USA (IV)
  • 23 Jul 2024 US FDA accepts resubmitted BLA for Remestemcel-L for steroid-refractory acute graft versus host disease (In children) for review

You need to be a logged in or subscribed to view this content Request demo

If your organization or you do not have a subscription, try one of the following:
  • Contacting your organization’s admin about adding this content to your AdisInsight subscription
  • Buying a PDF version of any individual profile
  • Request a free trial
If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top