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
Future Development Projects
The pipeline shows the developmental status of an unapproved drug or an unapproved indication and is not intended to promote or advertise any of the drugs.
- Note: Indicagtions and Approval are merely the expectations.
A.New Drugs/New Devices/regenerative medicine products (including global development projects)
As of September 2025
| Compound | Expected Indication |
Partner | Phase | Expected MA | |
|---|---|---|---|---|---|
| 1 | NPC-30 (GAIA-102) high-active NK-like cells |
neuroblastoma | GAIA BioMedicine Kyushu Univ |
PI | Dec 2026 |
| 2 | NPC-22 scopolamine |
hypersalivation | in-house | PII/III | Mar 2027 |
| 3 | NPC-33 naxitamab |
neuroblastoma | Y-mAbs Therapeutics |
PI | Mar 2027 |
| 4 | NPC-29 ubiquinol |
multiple system atrophy | Tokyo Univ | PIII in prep | Aug 2029 |
| 5 | NPC-31 P092 maleic acid |
prion disease | Gifu Univ | PI/II in prep | - |
| 6 | NPC-32 platelet aggregation |
cardiovascular surgery/emergency care | National Defense Medical College Waseda Univ |
preclinical | - |
| 7 | MD-02 | Laser systems for ENT | A.R.C. Laser Gmbh. | filing | - |
B.Life Cycle Management (including global development projects)
As of September 2025
| Compound | Expected Indication |
Partner | Phase | Expected MA | |
|---|---|---|---|---|---|
| 1 | NPC-12 RAPALIMUS |
epilepsy with focal cortical dysplasia type II (new indication) |
Showa Univ | PIII | Sep 2026 |
| 2 | NPC-12 RAPALIMUS |
primary immunodeficiency syndrome (new indication) |
Tokyo Medical and Dental Univ National Defense Medical College |
PII | Sep 2026 |
| 3 | NPC-18 RETYMPA |
ear canal regeneration (new indication) |
Kaken | PIII | Sep 2026 |
| 4 | NPC-25 Zintus |
hypozincemia (new formulation/additional dosage for pediatric) |
in-house | PIII | Sep 2027 |
| 5 | NPC-12 RAPALIMUS |
pure red cell aplasia (new indication) |
Shinshu Univ | PII | Jan 2028 |
| 6 | NPC-06 Fostin |
trifacial neuralgia (new indication) |
Pfizer | PIII | Sep 2028 |
| 7 | NPC-12 RAPALIMUS |
Pendred syndrome (new indication) |
Keio Univ Kitasato Univ |
PII | - |
| 8 | NPC-12 RAPALIMUS |
generalized scleroderma (new indication) |
Oita Univ | PI/II | - |
| 9 | NPC-12G RAPALIMUS Gel |
vascular abnormality-associated skin lesions (new indication) |
Wakayam Medical Univ. | PII/III in prep | - |
| 10 | NPC-15 Melatobel |
sleep-onset difficulty associated with mild cognitive disorder or dementia (new indication) |
in-house | PII | - |
| 11 | NPC-26 salgramostim |
non-tuberculous mycobacterial disease (new indication) |
Niigata Univ | PII | - |
C.Overseas Development
As of September 2025
| Compound | Expected Indication |
Partner | Phase | Expected MA | ||
|---|---|---|---|---|---|---|
| 1 | NPC-15 (Melatobel) |
sleep-onset difficulty associated with neurodevelopmental disorder in children |
- | CH | approved | Aug 2025 |
| 2 | NPC-02 (NOBELZIN) |
hypozincemia (new indication) |
- | CH | filing | Apr 2026 |
- Research and Development