Pipeline

Nobelpharma committed to development of critical but neglected drugs in order to fulfill social mandate

We have constantly been aspiring to conduct research and development of drugs, that are not the prime targets for many pharmaceutical companies due to questionable economic viability with a small number of patients (drugs for unmet medical needs). Our development pipeline mainly includes the drugs such as orphan drugs (drugs for rare diseases) that have been strongly requested by patients, academic societies, or the government, as well as off-label drugs and pediatric medicines. The efficient research and development processes by our small but highly capable organization is what enables us to obtain approvals for such drugs with a comparatively small market size.
While we heretofore have engaged in the development of many unapproved drugs, that were already available in US and Europe but were not developed in Japan despite their significant need, we will also actively take on the challenges of research and development under new and different concepts.

Development Process of Nobelpharma

Development Process of Nobelpharma

Future Development Projects

New Drugs/New Devices

As of August 2021

Compound Expected
Indication
Partner Phase Expected
Approval
NPC-26
sargramostim
autoimmune pulmonary alveolar proteinosis Partner Therapeutics filing Sep 2022
NPC-26
sargramostim
COVID-19 Partner Therapeutics P-III Mar 2023
NPC-09
aceneuramic acid
suppression of progressive muscle weakness in GNE myopathy in-house P-III Jun 2023
NPC-21
anti-CMV antibody
CMV infection Evec P-II -
NPC-22
scopolamine
hypersalivation Kitasato University P-I -
NPC-27
vaccinia virus vaccine
COVID-19 Tokyo Metropolitan Institute of Medical Science non-clinical -
NPC-28 mandibular regeneration Niigata University/
Kohjin Bio
non-clinical -

Life Cycle Management

As of August 2021

Compound Expected
Indication
Partner Phase Expected
Approval
NPC-12
RAPALIMUS
intractable lymphatic malformations/complicated vascular anomalies
(new indication)
Gifu University filed/P-III Sep 2021
/Sep 2023
NPC-05
Unitalc
secondary intractable pneumothorax
(new indication)
Nagoya Medical Center filed Mar 2022
NPC-06
Fostoin
neural field
(new indication)
Pfizer suspended -
NPC-12
RAPALIMUS
fibrodysplasia ossificans progressiva [FOP]
(new indication)
Kyoto University P-II/III -
NPC-12
RAPALIMUS
Pendred syndrome/DFNB4
(new indication)
Keio University P-I/IIa -
NPC-12
RAPALIMUS
epilepsy with focal cortical dysplasia type II
(new indication)
Showa University P-II -
NPC-12
RAPALIMUS
idiopathic multicentric Castleman disease
(new indication)
Nagasaki University P-II -
NPC-12
RAPALIMUS
primary immunodeficiency syndrome
(new indication)
Tokyo Medical and Dental University P-II -
NPC-26
sargramostim
non-tuberculosis mycobacterial disease (NTM)
(new indication)
Niigata University POC in prep -

Overseas Development

As of August 2021

Compound Expected
Indication
Partner Phase Expected MA
NPC-12G
topical silorimus
(RAPALIMUS Gel)
angiofibroma associated with tuberous sclerosis - US filed Dec 2021
CH filed Oct 2021
EU filing Apr 2023
NPC-17
thyroid cartilage fixation device
(TITANBRIDGE)
adductor spasmodic dysphonia - US trial in prep Jun 2023
EU CE marking in process Dec 2022
NPC-18
(RETYMPA)
tympanic perforation MEEI/Harvard University/New York University P-II -
NPC-19
[NPC-SE36]
Malaria vaccine
prevention of falciparum malaria Osaka University
GHIT
P-Ib -
  • Note: Indicagtions and Approval are merely the expectations.
Research and Development

R&D of Nobelpharma

Pipeline

Products

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