PipelineResearch & Development

Nobelpharma has earnestly addressed the development of medicines that

other companies do not pursue, in order to fulfill the needs of society.

Nobelpharma has continuously aspired to perform research and development of medicines that have not been targets for the other pharmaceutical companies due to limited operating revenue opportunities for medicines with a small number of patients (medicines for unmet medical needs). The core of our development pipeline has been medicines such as orphan drugs (drugs for rare diseases) that have been strongly requested by patients, academic societies, or the government, as well as off-labeled medicines and pediatric medicines. Our efficient research and development approach, conducted by the dedicated and selected few, is what enables us to obtain approvals for such medicines that have only small sales potential.

We have engaged in the development of many unapproved drugs, that were already available in the US and Europe but that were not yet developed in Japan despite the high need for them, and we will now move forward to take on the challenges to develop medicines under new concepts as well.

Development Process of Nobelpharma

Development Process of
Conventional
Pharmaceutical Companies
Development Process of
Nobelpharma
(Proven Record)
2-3 years
Basic Research
  • Baseline Examinations
  • Screening Tests
  • Studies of Pharmaceuticals and their manufacturing processes/Pharmacological Studies

No baseline studies in principle. Research activities and licence negotiations based on patient needs.

3-5 years
Non-clinical Tests
  • Physicochemical Tests
  • Toxicity Tests according to the Ordinance on GLP (Good Laboratory Practice)
  • Pharmacological/Pharmacokinetic Testing

Collaboration with academia in some cases.

3-7 years
Clinical Trials
  • Phase 1 Trial
  • Phase 2 Trial
  • Phase 3 Trial
16-42 months
2-3 years
Application/
Approval
  • Application for Marketing Approval
  • Review
  • Approval [NHI (National Health Insurance) Price Listing]
7-21 months
Post-
Marketing
  • Early Post-Marketing Surveillance
    • Post-Marketing Surveillance
    • Post-Marketing Clinical Trials according to Ordinances on GVP (Good Vigilance Practice)/GPSP (Good Post-marketing Study Practice)
  • Re-examination
  • Re-evaluation

Future Development Projects

As of Mar 2018

CompoundIndicationPartnerINDEnd of TrialNDAExpected Approval
NPC-09
N-acetylneuraminic acid
Distal MyopathyIn-houseOct 2010Oct 2017
P IP III/IV
NPC-12
Rapalimus Gel 0.2%SAKIGAKE
Designation*
Orphan Designation
new indicationIn-houseOct 2013Jun 2017Oct 2017Mar 2018
P II IIT completed
NPC-15
Melatonin
Sleep Disorders in Children with Neurodevelopmental DisabilitiesIn-houseFeb 2016Aug 2018Dec 2018Dec 2019
P III
(P II in progress)
NPC-16Gynecological DiseasesIn-houseDec 2014Apr 2017Aug 2017Jun 2018
NPC-17
titanium bridgeSAKIGAKE
Designation*
Orphan Designation
Spasmodic
Dysphonia
Translational Research Informatics CenterJun 2015Sep 2016Jun 2017Dec 2017
NPC-18
Myringa regeneration
tympanic perforationTranslational Research Informatics CenterDec 2014Jun 2016Mar2018Dec 2018
P III IIT in progress
molgramostim
Molgradex®
Pulmonary Alveolar ProteinosisSavaraJun 2019Jan 2020Sep 2020
P IIb/III
(ICT by Savara)
*
a system to put into practice innovative medicines / medical devices / regenerative medicines initially developed by Japan
  • IIT = Investigator Initiated Trial
  • ICT = International Clinical Trial
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