Nivolumab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2015
- First approval year
- 2015
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Nivolumab
- nivolumab bms
- Nivolumab bms
- nivolumab component of bms 986213
- Nivolumab component of bms-986213
- nivolumab component of opdualag
- Nivolumab component of opdualag
- opdivo
- Opdivo
- adagrasib nivolumab
- bms 936558
- bms 986213 component nivolumab
- bms 986298
- BMS-936558
- BMS-936558 (MDX-1106)
- BMS-936558 (MDX1106-04)
- BMS-936558 (Nivolumab)
- BMS-986213 COMPONENT NIVOLUMAB
- BMS-986298
- IV nivolumab
- IV Nivolumab
- mdx 1106
- MDX-1106
- mdx1106
- MDX1106
- nivolumab
- Nivolumab
- NIVOLUMAB
- Nivolumab - 240 mg
- Nivolumab - 480 mg
- Nivolumab (240 mg)
- Nivolumab (480 mg infusion)
- Nivolumab (BMS-936558)
- Nivolumab (Cohort A)
And 36 more, listed on the interactive page.
- CAS registry numbers
- 946414-94-4
- ChEMBL ID
- CHEMBL2108738
- RxNorm IDs (RxCUI)
- 1597876
- FDA ingredient codes (UNII)
- 31YO63LBSN
- L01FF01
- L01XC17
Sources for recorded values
- Applicant
- BRISTOL MYERS SQUIBB
- Approval date
- 22 Dec 2014
- Application number
- BLA125554
- Status
- Authorised
- Status date
- 19 Jun 2015
- Authorisation date
- 19 Jun 2015
- Approved indications
- Melanoma Opdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older.Relative to nivolumab monotherapy, an increase in progression-free survival (PFS) and overall survival (OS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression (see sections 4.4 and 5.1). Adjuvant treatment of melanoma Opdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with Stage IIB or IIC melanoma, or melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection (see section 5.1). Non-small cell lung cancer (NSCLC) Opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation. Opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. Neoadjuvant treatment of NSCLC Opdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1% (see section 5.1 for selection criteria). Neoadjuvant and adjuvant treatment of NSCLC Opdivo, in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by OPDIVO as monotherapy as adjuvant treatment, is indicated for the treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1% (see section 5.1 for selection criteria). Malignant pleural mesothelioma (MPM) Opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. Renal cell carcinoma (RCC) Opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. Opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5.1). Opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (see section 5.1). Classical Hodgkin lymphoma (cHL) Opdivo in combination with doxorubicin, vinblastine and dacarbazine (AVD) is indicated for adults and adolescents 12 years of age and older with previously untreated Stage III or IV classical Hodgkin lymphoma. Opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin. Opdivo in combination with brentuximab vedotin is indicated for the treatment of children 5 years of age and older, adolescents and adults up to 30 years of age with relapsed or refractory classical Hodgkin lymphoma after one prior line of therapy (see section 5.1). Squamous cell cancer of the head and neck (SCCHN) Opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum-based therapy (see section 5.1). Urothelial carcinoma Opdivo in combination with cisplatin and gemcitabine is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. Opdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy. Adjuvant treatment of urothelial carcinoma Opdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (MIUC) with tumour cell PD-L1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of MIUC (see section 5.1). Mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC) Opdivo in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high colorectal cancer in the following settings:- first-line treatment of unresectable or metastatic colorectal cancer;- treatment of metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy (see section 5.1). Oesophageal squamous cell carcinoma (OSCC) Opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%. Opdivo in combination with fluoropyrimidine‑ and platinum‑based combination chemotherapy is indicated for the first‑line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD‑L1 expression ≥ 1%. Opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine‑ and platinum‑based combination chemotherapy. Adjuvant treatment of oesophageal or gastro‑oesophageal junction cancer (OC or GEJC) Opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro‑oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy (see section 5.1). Gastric, gastro‑oesophageal junction (GEJ) or oesophageal adenocarcinoma Opdivo in combination with fluoropyrimidine‑ and platinum‑based combination chemotherapy is indicated for the first‑line treatment of adult patients with HER2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express PD‑L1 with a combined positive score (CPS) ≥ 5. Hepatocellular carcinoma (HCC) Opdivo in combination with ipilimumab is indicated for the first‑line treatment of adult patients with unresectable or advanced hepatocellular carcinoma.
- Product number
- EMEA/H/C/003985
- Authorisation holder
- Bristol-Myers Squibb Pharma EEIG
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Carcinoma, Non-Small-Cell Lung
- Carcinoma, Renal Cell
- Carcinoma, Transitional Cell
- Colorectal Neoplasms
- Hodgkin Disease
- Melanoma
- Mesothelioma
- Squamous Cell Carcinoma of Head and Neck
- Urologic Neoplasms
European medicines record
- Patents
- 0
- Designations
- 8
- Earliest recorded loss of exclusivity
- 13 Apr 2031
- First in class
- No
- Fast track
- Yes
- Breakthrough designation
- Yes
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- Yes
- Availability
- Prescription only
- Pharmacology name
- nivolumab
- Type
- Antibody
- Drug name stem
- -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Action
- Binding
- Action type
- Binding
- Target
- programmed cell death 1 (CD279)
- Gene symbol
- PDCD1
- Protein identifier
- Q15116
- Median affinity
- 10.28
- Affinity units
- pEC50
- Primary target
- Yes
- Mechanism
- Programmed cell death protein 1 inhibitor
- Action type
- Inhibitor
- Target
- Programmed cell death protein 1
- Protein identifier
- Q15116
Open Targets mechanisms
- Mechanism
- Programmed cell death protein 1 inhibitor
- Action type
- Inhibitor
- Target
- Programmed cell death protein 1
- Condition
- Leukemia, Lymphocytic, Chronic, B-Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000095
- Subject identifier
- D015451
- Condition
- Lymphoma, Follicular
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000096
- Subject identifier
- D008224
- Condition
- Sarcoma, Ewing
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000174
- Subject identifier
- D012512
- Condition
- HIV Infections
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000180
- Subject identifier
- D015658
- Condition
- Squamous Cell Carcinoma of Head and Neck
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000181
- Subject identifier
- D000077195
- Condition
- Carcinoma, Squamous Cell
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000181
- Subject identifier
- D002294
- Condition
- Carcinoma, Hepatocellular
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000182
- Subject identifier
- D006528
- Condition
- Hodgkin Disease
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000183
- Subject identifier
- D006689
- Condition
- Prostatic Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000196
- Subject identifier
- D011471
- Condition
- Myelodysplastic Syndromes
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000198
- Subject identifier
- D009190
- Condition
- Squamous Cell Carcinoma of Head and Neck
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000199
- Subject identifier
- D000077195
- Condition
- Lymphoma, T-Cell, Peripheral
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000211
- Subject identifier
- D016411
- Condition
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000220
- Subject identifier
- D054198
- Condition
- Leukemia, Myeloid, Acute
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000222
- Subject identifier
- D015470
- Condition
- Adenocarcinoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000228
- Subject identifier
- D000230
- Condition
- Urinary Bladder Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000294
- Subject identifier
- D001749
- Condition
- Breast Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000305
- Subject identifier
- D001943
- Condition
- Carcinoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000313
- Subject identifier
- D002277
- Condition
- Glioma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000326
- Subject identifier
- D005910
- Condition
- Carcinoma, Renal Cell
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000335
- Subject identifier
- D002292
- Condition
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000339
- Subject identifier
- D015464
- Condition
- Carcinoma, Renal Cell
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000349
- Subject identifier
- D002292
- Condition
- Colorectal Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000365
- Subject identifier
- D015179
- Condition
- Melanoma
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000389
- Subject identifier
- D008545
- Condition
- Lymphoma, Large B-Cell, Diffuse
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000403
- Subject identifier
- D016403
And 143 more, listed on the interactive page.
- Condition identifier
- EFO_0000181
- Condition identifier
- EFO_0000182
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000183
- Condition identifier
- EFO_0000198
- Condition identifier
- EFO_0000199
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000220
- Condition identifier
- EFO_0000222
- Condition identifier
- EFO_0000228
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000294
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000313
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000339
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000349
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000389
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000403
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000503
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000514
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000519
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000558
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000564
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000571
- Condition identifier
- EFO_0000574
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000588
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0000621
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000637
- Highest recorded phase
- 2
And 352 more, listed on the interactive page.
- Event
- adrenal insufficiency
- Reports
- 694
- Reporting signal score
- 1,396.27
- Event
- autoimmune colitis
- Reports
- 195
- Reporting signal score
- 660.103
- Event
- cachexia
- Reports
- 217
- Reporting signal score
- 503.152
- Event
- cholangitis
- Reports
- 207
- Reporting signal score
- 370.983
- Event
- colitis
- Reports
- 1,466
- Reporting signal score
- 2,506.63
- Event
- drug hypersensitivity
- Reports
- 34
- Reporting signal score
- 365.958
- Event
- enterocolitis
- Reports
- 211
- Reporting signal score
- 391.456
- Event
- fulminant type 1 diabetes mellitus
- Reports
- 237
- Reporting signal score
- 794.691
- Event
- hepatitis
- Reports
- 608
- Reporting signal score
- 619.024
- Event
- hyperthyroidism
- Reports
- 553
- Reporting signal score
- 886.974
- Event
- hypophysitis
- Reports
- 568
- Reporting signal score
- 1,801.92
- Event
- hypopituitarism
- Reports
- 164
- Reporting signal score
- 462.364
- Event
- hypothyroidism
- Reports
- 1,089
- Reporting signal score
- 1,861.08
- Event
- immune-mediated adverse reaction
- Reports
- 305
- Reporting signal score
- 1,052.84
- Event
- immune-mediated enterocolitis
- Reports
- 459
- Reporting signal score
- 1,603.11
- Event
- immune-mediated hepatitis
- Reports
- 270
- Reporting signal score
- 895.048
- Event
- injection site pain
- Reports
- 4
- Reporting signal score
- 549.567
- Event
- malignant neoplasm progression
- Reports
- 2,832
- Reporting signal score
- 5,082.28
- Event
- myasthenia gravis
- Reports
- 291
- Reporting signal score
- 606.783
- Event
- myocarditis
- Reports
- 449
- Reporting signal score
- 767.5
- Event
- myositis
- Reports
- 244
- Reporting signal score
- 365.834
- Event
- pemphigoid
- Reports
- 435
- Reporting signal score
- 787.33
- Event
- pneumonitis
- Reports
- 1,250
- Reporting signal score
- 2,250.35
- Event
- pyrexia
- Reports
- 1,506
- Reporting signal score
- 436.334
- Event
- thyroiditis
- Reports
- 330
- Reporting signal score
- 803.585
And 2 more, listed on the interactive page.
- NCT00703469
- NCT00836888
- NCT01629758
- NCT01928394
- NCT01968109
- NCT02261285
- NCT02261298
- NCT02419417
- NCT02426892
- NCT02472977
- NCT02476123
- NCT02593786
- NCT02598960
- NCT02614456
- NCT02628574
- NCT02712905
- NCT02754141
- NCT02775292
- NCT02817633
- NCT02864316
- NCT02901145
- NCT02913313
- NCT02925234
- NCT03155061
- NCT03195478
And 1,018 more, listed on the interactive page.
- Dose
- 240 mg
- Route
- Intravenous
- How often
- Every 2 weeks
Conditions of use
- Administer by intravenous infusion after dilution
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Heavy chain
- Type
- Protein
- Organism
- Homo sapiens
- Sequence
- QVQLVESGGGVVQPGRSLRLDCKASGITFSNSGMHWVRQAPGKGLEWVAVIWYDGSKRYYADSVKGRFTISRDNSKNTLFLQMNSLRAEDTAVYYCATNDDYWGQGTLVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPEFLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEGNVFSCSVMHEALHNHYTQKSLSLSLGK
- Component
- Light chain
- Type
- Protein
- Organism
- Homo sapiens
- Sequence
- EIVLTQSPATLSLSPGERATLSCRASQSVSSYLAWYQQKPGQAPRLLIYDASNRATGIPARFSGSGSGTDFTLTISSLEPEDFAVYYCQQSSNWPRTFGQGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- 0003-3120
- 0003-3734
- 0003-3756
- 0003-3772
- 0003-3774
- 0003-6120
- 0003-7125
Related records
Trials (1,735)
- 11C-Metomidate PET/CT for Endocrine Hypertension and Characterisation of Adrenal Tumours
- 5-Azacitidine Plus PD-1/PD-L1 Inhibitor With PD-1/PD-L1 Refractory Tumors
- 5-Azacytidine and/or Nivolumab in Resectable HPV-Associated HNSCC
- A 2-part Phase 1/2 Open-label Trial on ODM-212
- A BIOmarker Driven Trial With Nivolumab and Ipilimumab or VEGFR tKi in Naïve Metastatic Kidney Cancer
- A Biomarker Study in Advanced Mucosal or Acral Lentiginous Melanoma Receiving Nivolumab in Combination With Ipilimumab
- A Case Study of Nivolumab for Relapsed/Refractory Primary Central Nervous System Lymphoma
- A CD8 Positron Emission Tomography With Computed Tomography (PET/CT) Study Using ⁸⁹Zr Df-IAB22M2C in Patients With Metastatic Melanoma Receiving Bempegaldesleukin (NKTR-214) and Nivolumab
- A Clinical Guideline-based Management of Type-2 Diabetes by Ayurvedic Practitioners in Nepal
- A Clinical Study Evaluating Nivolumab-containing Treatments in Patients With Advanced Non-small Cell Lung Cancer After Failing Previous PD-1/(L)1 Therapy and Chemotherapy
- A Clinical Study of the Pharmacokinetics and Safety of BCD-263 and Opdivo® as Monotherapy in Subjects With Advanced Melanoma of the Skin
- A Clinical Study to Assess the Combination of Two Drugs (177Lu-DOTATATE and Nivolumab) in Neuroendocrine Tumours
- A Clinical Trial of a New Combination Treatment, Domvanalimab and Zimberelimab, Plus Chemotherapy, for People With an Upper Gastrointestinal Tract Cancer That Cannot be Removed With Surgery That Has Spread to Other Parts of the Body
- A Clinical Trial of Entinostat in Combination With Nivolumab for Patients With Previously Treated Unresectable or Metastatic Cholangiocarcinoma and Pancreatic Adenocarcinoma
- A Clinical Trial on Combined (Neo-)Adjuvant Intravenous Plus Intracranial Administration of Ipilimumab and Nivolumab in Recurrent Glioblastoma
- A Clinical Trial: Adjuvant Low-dose Ipilimumab + Nivolumab After Resection of Melanoma Macrometastases
- A Comparative Dose-finding Study of RS-113 in Patients With Metastatic Castration-resistant Prostate Cancer
- A DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC)
- A Dose Escalation and Cohort Expansion Study of Anti-CD27 (Varlilumab) and Anti-PD-1 (Nivolumab) in Advanced Refractory Solid Tumors
- A Dose Escalation and Cohort Expansion Study of NKTR-214 in Combination With Nivolumab and Other Anti-Cancer Therapies in Patients With Select Advanced Solid Tumors
Approved for (24)
- Cancer
- Chromophobe renal cell carcinoma
- Classic Hodgkin lymphoma
- Clear cell renal carcinoma
- Colorectal adenocarcinoma
- Colorectal cancer
- Colorectal carcinoma
- Colorectal neoplasm
- Cutaneous melanoma
- Head and neck squamous cell carcinoma
- Hodgkins lymphoma
- Malignant pleural mesothelioma
- Melanoma
- Mesothelioma
- Metastatic melanoma
- Neoplasm
- Non-small cell lung carcinoma
- Oral cavity squamous cell carcinoma
- Oropharynx squamous cell carcinoma
- Papillary renal cell carcinoma
In development for (145)
- Acute lymphoblastic leukemia Phase 1
- Acute myeloid leukemia Phase 2
- Adenocarcinoma Phase 3
- Adrenal cortex carcinoma Phase 2
- Anaplastic large cell lymphoma Phase 2
- B-cell chronic lymphocytic leukemia Phase 2
- Basal cell carcinoma Phase 2
- Biliary tract cancer Phase 2
- Biliary tract neoplasm Phase 2
- Brain cancer Phase 3
- Brain neoplasm Phase 3
- Breast cancer Phase 3
- Breast carcinoma Phase 3
- Carcinoid tumor Phase 2
- Carcinoma Phase 2
- Carcinoma of esophagus Phase 3
- Carcinosarcoma Phase 2
- Central nervous system cancer Phase 2
- Cervical adenocarcinoma Phase 2
- Cervical cancer Phase 2
Other linked conditions (4)
- Childhood malignant neoplasm
- Encephalitis
- Pancreatic neoplasm
- Pleural mesothelioma
Targets (1)
- PDCD1 Programmed cell death protein 1 inhibitor