TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT06433635
Drug: Cariprazine
Normalized name: Cariprazine
DrugBank: Cariprazine (DB06016)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 1. Cariprazine monotherapy outperformed placebo in improving depressive symptoms in most large randomized control trials (RCT). Pooled data showed higher remission rates (30.2%) with cariprazine (1.5 mg and 3 mg/day) compared to placebo (20.9%). Its efficacy extends to bipolar I depression, including mixed features and anxiety.~2. Common adverse effects include nausea (8%) and akathisia (7%). Somnolence and sedation were slightly more common with cariprazine than placebo.~3. Results from a large RCT evaluating cariprazine for bipolar disorder maintenance treatment (NCT03573297) are awaited. An open-label trial reported reduced manic symptoms over 16 weeks.~4. Cariprazine is a D3-preferring partial agonist for D3 and D2 receptors. It antagonizes 5-HT2A and 5-HT2B receptors and partially agonizes 5-HT1A receptors. Affinity for 5-HT1C and histamine 1 receptors is low to moderate.
Study: NCT06433635
Drug: Aripiprazole/Escitalopram combination
DrugBank: Citalopram (DB00215)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 1. 40-70% of bipolar patients use antidepressants, often with antipsychotics or mood stabilizers. Aripiprazole lacks efficacy in bipolar depression but is used for mania. Escitalopram, studied alongside mood stabilizers, showed some efficacy.~2. Aripiprazole in bipolar depression trials led to higher rates of akathisia, insomnia, nausea, fatigue, and impulse control disorders. Escitalopram's is generally safe but adverse effects include nausea, diarrhea, insomnia, dry mouth, ejaculatory dysfunction and dizziness.~3. Aripiprazole monotherapy in bipolar I patients reduced relapse rates and delayed relapse time, but not for depressive episodes.~4. Aripiprazole acts as a partial agonist at D2, D3, 5-HT1A, and 5-HT2C receptors, with antagonistic effects on α1 and possibly H1 receptors. Escitalopram is highly selective for the serotonin transporter, with no significant activity at other receptors.
Study: NCT06433635
Drug: Quetiapine
Normalized name: Quetiapine
DrugBank: Quetiapine (DB01224)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 1. Both immediate and extended-release quetiapine monotherapies showed superiority over placebo in acute BD depression across three 8-week randomized trials, confirmed by meta-analysis. Quetiapine exhibited significantly higher remission rates (52.8%) compared to placebo (34.7%) and improved various aspects of life, including quality of life, clinical global impression, sleep, functioning, and anxiety.~2. Common adverse events of quetiapine include sedation, hypotension, increased appetite, weight gain, dyslipidemia, and elevated glucose levels, particularly in a population already at risk.~3. Four studies examined quetiapine's maintenance effects in patients with manic, mixed, or depressive episodes. Overall, quetiapine prolonged the time to recurrence for both depressive and manic episodes.
Study: NCT06433635
Drug: Lurasidone
Normalized name: Lurasidone
DrugBank: Lurasidone (DB08815)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 1. Lurasidone, either alone or with lithium/valproate, proved more effective than placebo for acute BD depression in two 6-week randomized trials. Remission rates were significantly higher with lurasidone monotherapy (40.9%) and in combination (50.3%) compared to placebo (24.7% and 35.4% respectively). Lurasidone also improved anxiety, quality of life, and disability.~2. Common mild adverse events included nausea, headache, akathisia, somnolence, sedation, dry mouth, and vomiting. Weight gain, dyslipidemia, and increased glucose levels were not observed.~3. In a 6-month double-blind discontinuation study post-acute treatment response, lurasidone combined with lithium/valproate prolonged time to depressive episode recurrence compared to placebo (hazard ratio: 0.68). Although not statistically significant due to low placebo recurrence and shorter follow-up, it hints at maintenance efficacy.
Study: NCT06178159
Drug: Disitamab Vedotin Injection
Normalized name: Brentuximab Vedotin
DrugBank: Disitamab vedotin (DB17208)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 2.0mg/kg, intravenous infusion，D1, every 2 weeks, Every 6 weeks is a treatment cycle. A total of 3 cycles (18 weeks) of treatment are performed.
Study: NCT06178159
Drug: Pertuzumab Injection
Normalized name: pertuzumab Injection
DrugBank: Pertuzumab (DB06366)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Initial dose 840mg, after 2nd dose 420mg intravenous infusion， every 3 weeks
Study: NCT06178159
Drug: Toripalimab
Normalized name: Toripalimab
DrugBank: Toripalimab (DB15043)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 3.0 mg/kg, intravenous infusion, D1, every 2 weeks
Study: NCT06503107
Drug: Nanobody-based biepitope BCMA-targeting CAR-T cells
Normalized name: Autologous bi-epitope BCMA-targeted CAR T-cells
DrugBank: Ciltacabtagene autoleucel (DB16738)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Each patient will receive nanobody-based biepitope BCMA-targeting CAR-T cell by intravenous infusion on day 0.
Study: NCT05887219
Drug: Group A 4 % Hydroquinone Cream Topically and Oral Tranexamic Acid
DrugBank: Tranexamic acid (DB00302)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Group A was managed with 4% hydroquinone cream as an adjuvant to oral tranexamic acid (250 mg twice daily) for 6 months
Study: NCT05887219
Drug: Group B Azelaic Acid 20 % Cream for 6 months
DrugBank: Azelaic acid (DB00548)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Group B was managed with topical 20% azelaic acid (daily at night) for six months.
Study: NCT04703621
Drug: Daratumumab Injection
Normalized name: daratumumab Injection
DrugBank: Daratumumab (DB09331)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: subcutaneious daratumumab administration
Study: NCT00002352
Drug: Lobucavir
Normalized name: Lobucavir
DrugBank: Lobucavir (DB12531)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT05952089
Drug: Danicamtiv
Normalized name: Danicamtiv
DrugBank: Danicamtiv (DB18962)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Specified dose on specified days
Study: NCT05952089
Drug: Midazolam
Normalized name: Midazolam
DrugBank: Midazolam (DB00683)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Specified dose on specified days
Study: NCT05002686
Drug: Sintilimab
Normalized name: Sintilimab
DrugBank: Sintilimab (DB15765)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 200 mg Q3W on Day 1 by IV infusion
Study: NCT05002686
Drug: Albumin-Paclitaxel
DrugBank: Paclitaxel (DB01229)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: 200 mg/m\^2 Q3W on Day 1 by IV infusion
Study: NCT05002686
Drug: Oxaliplatin
Normalized name: Oxaliplatin
DrugBank: Oxaliplatin (DB00526)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 130 mg/m\^2 Q3W on Day 1 by IV infusion
Study: NCT04387734
Drug: Ocrelizumab
Normalized name: Ocrelizumab
DrugBank: Ocrelizumab (DB11988)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Ocrevus will be administered following the FDA's regulations.
Study: NCT00021489
Drug: Abacavir sulfate
Normalized name: Abacavir Sulfate
DrugBank: Abacavir (DB01048)
Approvals — FDA: yes, EMA: yes, PMDA: no
Study: NCT00021489
Drug: Mycophenolate mofetil
Normalized name: Mycophenolate Mofetil
DrugBank: Mycophenolate mofetil (DB00688)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT06610760
Drug: Ursodeoxycholic Acid
Normalized name: Ursodeoxycholic acid
DrugBank: Ursodeoxycholic acid (DB01586)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subjects will be instructed to take one capsule (250mg) of ursodeoxycholic acid three times daily, and visit the hospital every 4 weeks for evaluation of the subjective symptoms and to receive a new supply of medication.
Study: NCT06657690
Drug: Irinotecan liposome
Normalized name: Irinotecan liposome
DrugBank: Irinotecan (DB00762)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Irinotecan liposome injection, 50mg/m2, D1、D15, ivgtt, Q4w.
Study: NCT06657690
Drug: S-1
Normalized name: LIS-1
DrugBank: Tegafur (DB09256)
Approvals — FDA: no, EMA: yes, PMDA: no
Description: S-1, D1-D14, BID, p.o., Q4w (BSA \< 1.25 m2, 40 mg/dose; 1.25 m2 ⩽ BSA \< 1.5 m2, 50 mg/dose; BSA ⩾ 1.5 m2, 60mg/dose).
Study: NCT06655883
Drug: Suvorexant
Normalized name: Suvorexant
DrugBank: Suvorexant (DB09034)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Oral Tablet
Study: NCT06657105
Drug: Baxdrostat
Normalized name: Baxdrostat
DrugBank: Baxdrostat (DB19090)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Baxdrostat tablet will be administered orally.
Study: NCT06027268
Drug: Trilaciclib
Normalized name: Trilaciclib
DrugBank: Trilaciclib (DB15442)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: IV infusion Day 1 and Day 8 every 21 days, at dose of 240 mg/m2
Study: NCT06027268
Drug: Pembrolizumab
Normalized name: Pembrolizumab
DrugBank: Pembrolizumab (DB09037)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: IV infusion Day 1 every 21 days, at dose of 200 mg
Study: NCT06027268
Drug: Gemcitabine
Normalized name: Gemcitabine
DrugBank: Gemcitabine (DB00441)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: IV infusion Day 1 and Day 8 every 21 days, at dose 1000 mg/m2
Study: NCT06027268
Drug: Carboplatin
Normalized name: Carboplatin
DrugBank: Carboplatin (DB00958)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: IV infusion Day 1 and Day 8 every 21 days, at dose area under curve (AUC) 2 (maximum of 300 mg)
Study: NCT04483531
Drug: Odevixibat
Normalized name: Odevixibat
DrugBank: Odevixibat (DB16261)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: A4250 is a small molecule and selective inhibitor of IBAT
Study: NCT06187727
Drug: Henagliflozin
Normalized name: Henagliflozin
DrugBank: Henagliflozin (DB11939)
Approvals — FDA: no, EMA: no, PMDA: no
Description: After primary PCI, Henggliflozin or Placebo was administered within 24 hours, followed by daily oral administration until 6 months post-acute myocardial infarction.
Study: NCT05040126
Drug: Linezolid
Normalized name: Linezolid
DrugBank: Linezolid (DB00601)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Participants will have a screening period of up to 14 days and will be randomized to one of the study arms in the ratio of 1:1:1, using an interactive web response system.~Each participant will receive 26 weeks of treatment. If the participant's 16th-week sample remains culture positive, treatment will be extended up to 39 weeks.~Participants will be followed for 48 weeks after the end of treatment
Study: NCT05040126
Drug: Bedaquiline
Normalized name: Bedaquiline
DrugBank: Bedaquiline (DB08903)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Bedaquiline will be administered as four 100 mg tablets (400 mg) by mouth once a day for 2 weeks, followed by two 100 mg tablets (200 mg) by mouth three times a week for 24 weeks in all three arms
Study: NCT05040126
Drug: Pretomanid
Normalized name: Pretomanid
DrugBank: Pretomanid (DB05154)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Pretomanid is administered as one tablet once a day for 26 weeks in all three arms
Study: NCT05414864
Drug: Ramelteon (RozeremR)
Normalized name: Ramelteon
DrugBank: Ramelteon (DB00980)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 8mg daily
Study: NCT05814991
Drug: Nitroglycerin solution
Normalized name: nitroglycerin Injectable Solution
DrugBank: Nitroglycerin (DB00727)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Controlled hypotension will be induced (intravenous administration of nitroglycerin 2-10 µg/kg/min) 15 minutes prior to the start of mucosal detachment, and will be sustained for the osteotomy stage.
Study: NCT06257316
Drug: EPHEDrine Hydrochloride 5 mg/ml
Normalized name: ephedrine hydrochloride 5 MG/ML
DrugBank: Ephedrine (DB01364)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: In the present study, the expected rate of recovery of the internal carotid artery according to the dose of the inotropic agent was similar to that in a previous study in which the fraction maintaining mean arterial pressure within 80% of baseline by dose of inotropic agent was 0.9% for the ephedrine 0.1, 0.6, 0.8, 1. 0, 1.2, and 1.4 doses (mg/kg) were 9.9%, 21%, 41%, 47%, 65.5%, and 40%, respectively (Br J Anaesth. 2023 May;130(5):603-610), and it was assumed that the rate of internal carotid artery recovery by inotrope dose would be 90% of that result.~The study will randomize to dose in six cohorts and will include dose group and cohort variables in a logistic regression model to assess the trend between inotropic dose and rate of carotid revascularization after correcting for cohort effects on the outcome variable.
Study: NCT05558150
Drug: Ilaprazole
Normalized name: ilaprazole
DrugBank: Ilaprazole (DB11964)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Ilaprazole 10mg
Study: NCT05558150
Drug: Aceclofenac
Normalized name: Aceclofenac
DrugBank: Aceclofenac (DB06736)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Aceclofenac 100mg
Study: NCT06232239
Drug: Empagliflozin-Test product
Normalized name: empagliflozin Oral Product
DrugBank: Empagliflozin (DB09038)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Empagliflozin 10 mg tablets Test product Manufactured by: Thai Meiji Pharmaceuticals Co., Ltd., Thailand
Study: NCT06232239
Drug: Empagliflozin-Reference product
Normalized name: empagliflozin Oral Product
DrugBank: Empagliflozin (DB09038)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Empagliflozin 10 mg tablets Reference product Manufactured by: Boehringer Ingelheim Pharma Gmbh \& Co. Kg, Germany
Study: NCT06188052
Drug: Tranexamic acid
Normalized name: Tranexamic Acid
DrugBank: Tranexamic acid (DB00302)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Comparing the 3 groups regarding intraoperative bleeding, hemoglobin level pre and postoperative and the need of blood transfusion
Study: NCT05633914
Drug: Tucidinostat
Normalized name: tucidinostat
DrugBank: Tucidinostat (DB06334)
Approvals — FDA: no, EMA: no, PMDA: yes
Description: 20mg, po., biw, q3w
Study: NCT05633914
Drug: nab-paclitaxel
Normalized name: NAB-PACLITAXEL COMPONENT PACLITAXEL
DrugBank: Paclitaxel (DB01229)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: 125mg/m2, d1, iv.drip, q7d
Study: NCT04822376
Drug: ansuvimab
Normalized name: Ansuvimab
DrugBank: Ansuvimab (DB16385)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Human monoclonal antibody to Zaire strain GP (EBOV GP)
Study: NCT04694612
Drug: Favipiravir
Normalized name: favipiravir
DrugBank: Favipiravir (DB12466)
Approvals — FDA: no, EMA: no, PMDA: yes
Description: Comparison of clinical improvement and clinical deterioration between those receiving Favipiravir compared to placebo in the patients with mild COVID-19
Study: NCT04694612
Drug: Remdesivir
Normalized name: remdesivir
DrugBank: Remdesivir (DB14761)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Comparison of clinical improvement and clinical deterioration between those receiving Favipiravir compared to Remdesivir Injection in the patients with moderate COVID-19
Study: NCT05962450
Drug: PD-1
Normalized name: NPD-1
DrugBank: PD-168393 (DB07662)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Intravenous infusion, according to the drug instructions.
Study: NCT05962450
Drug: Regorafenib
Normalized name: Regorafenib
DrugBank: Regorafenib (DB08896)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Oral administration, according to the drug instructions.
Study: NCT05962502
Drug: Cetuximab and irinotecan
Normalized name: Cetuximab
DrugBank: Cetuximab (DB00002)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: chemotherapy plus targeted therapy
Study: NCT06494280
Drug: programmed intermittent Bolus epidural analgesia
Normalized name: epidermal growth factor
DrugBank: Nepidermin (DB14145)
Approvals — FDA: no, EMA: no, PMDA: no
Description: About 30 minutes after the end of the epidural and administration of the loading dose, the woman will be asked to report her pain level. If the VAS score \<30, the woman will receive the study group protocol for pain maintenance, i.e., a programmed intermittent bolus of 10 ml of 0.1% bupivacaine and 2 μg/ml fentanyl every hour until the completion of labor and suturing of the incision. The participant can add to herself 5 ml of the same solution of Bupivacaine and Fentanyl every 30 minutes. The maximum dose that the parturient is allowed to receive is 20 ml for one hour.~If a breakthrough pain appears during labor, a bolus of 10 ml of anesthetic solution with the same concentration will be added.~Participants with a VAS score \>30 after 30 minutes of the loading dose will be asked to perform a new epidural (if it was decided that the epidural failed) otherwise her data will not be collected for the final analysis of the study.
Study: NCT03829579
Drug: Esketamine
Normalized name: ESKETAMINE
DrugBank: Esketamine (DB11823)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Participants will self-administer esketamine nasal spray, under the supervision of the healthcare professional at the site of care. A starting dose of 56 milligram (mg) will be administered intranasally into each nostril on Day 1 with subsequent doses of 56 mg or 84 mg administered during Weeks 1-4 (2 treatment sessions per week). For participants who respond, treatment is continued as follows: 56 mg or 84 mg of esketamine nasal spray during Weeks 5-8 (once weekly), and Week 9 onwards (every 2 weeks or once weekly), with period re-evaluation to determine the need for continued treatment. Doses will be adjusted based on efficacy and tolerability to the previous dosing.
Study: NCT06207123
Drug: Ponatinib
Normalized name: Ponatinib
DrugBank: Ponatinib (DB08901)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Ponatinib is used to treat certain types of chronic myeloid leukemia (CML; a type of cancer of the white blood cells).
Study: NCT06504901
Drug: Tislelizumab
Normalized name: Tislelizumab
DrugBank: Tislelizumab (DB14922)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Tislelizumab 200mg ivd D1
Study: NCT06504901
Drug: Interleukin-2
Normalized name: INTERLEUKIN-2
DrugBank: Human interleukin-2 (DB14865)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Interleukin 2 100IU HD,QOD d1-d14
Study: NCT06504901
Drug: Oxaliplatin
Normalized name: Oxaliplatin
DrugBank: Oxaliplatin (DB00526)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Oxaliplatin 130mg/m2 ivd, d1
Study: NCT06504901
Drug: Neupogen
Normalized name: Neupogen
DrugBank: Filgrastim (DB00099)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: rhG-CSF 5mcg/kg HD, QD d1-d14
Study: NCT06207123
Drug: Vincristine
Normalized name: Vincristine
DrugBank: Vincristine (DB00541)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Vincristine is a chemotherapy medication used to treat various types of cancer, including leukemia, lymphoma, neuroblastoma, and Wilms tumor. Vincristine belongs to the category of vinca alkaloids, a class of drugs that function by impeding the proper division of cancer cells.
Study: NCT06207123
Drug: Dexamethasone
Normalized name: Dexamethasone
DrugBank: Dexamethasone (DB01234)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Dexamethasone is used to treat cancer, to decrease inflammation and sometimes used before and after chemotherapy to prevent or treat nausea and/or vomiting. It is given in the vein (IV) or orally (by mouth)
Study: NCT06525272
Drug: Recombinant Human Chymotrypsin(OsrhCT)
Normalized name: Chymotrypsin
DrugBank: Chymotrypsin (DB09375)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Recombinant Human Chymotrypsin (OsrhCT), provided by Wuhan Healthgen Biotechnology Corporation, 4,000U/vial, freeze-dried powder, 20ml of the prepared drug will be injected into the thoracic cavity through a chest tube.
Study: NCT06525272
Drug: Placebo for Recombinant Human Chymotrypsin(OsrhCT)
Normalized name: Chymotrypsin
DrugBank: Chymotrypsin (DB09375)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Placebo for Recombinant Human Chymotrypsin (OsrhCT), provided by Wuhan Healthgen Biotechnology Corporation, freeze-dried powder, stored at 2-8°C.
Study: NCT06363630
Drug: Itraconazole
Normalized name: Itraconazole
DrugBank: Itraconazole (DB01167)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Specified dose on specified days.
Study: NCT06363630
Drug: Rifampin
Normalized name: Rifampin
DrugBank: Rifampin (DB01045)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Specified dose on specified days
Study: NCT06363630
Drug: Golcadomide
Normalized name: Golcadomide
DrugBank: Golcadomide (DB18115)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Specified dose on specified days
Study: NCT05286281
Drug: PF-07265803
Normalized name: PF-05089771
DrugBank: PF-05089771 (DB14856)
Approvals — FDA: no, EMA: no, PMDA: no
Description: PF-07265803 is a p38 inhibitor formulated for oral delivery.
Study: NCT04984798
Drug: Vitamin E
Normalized name: Vitamin E
DrugBank: Vitamin E (DB00163)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Twice daily oral supplementation with Vitamin E for 6-9 weeks.
Study: NCT05700045
Drug: Dexmedetomidine
Normalized name: Dexmedetomidine
DrugBank: Dexmedetomidine (DB00633)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: each side dexmedetomidine 0.5ug/kg TAP block
Study: NCT06205706
Drug: BI-1910
Normalized name: BI 2536
DrugBank: BI 2536 (DB16107)
Approvals — FDA: no, EMA: no, PMDA: no
Description: BI-1910 administered as a flat-dose IV infusion once every 3 weeks
Study: NCT06205706
Drug: Pembrolizumab
Normalized name: Pembrolizumab
DrugBank: Pembrolizumab (DB09037)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Pembrolizumab be administered as an IV infusion at its standard flat dose (200 mg) once every 3 weeks prior to the BI-1910 infusion
Study: NCT04986852
Drug: Olinvacimab
Normalized name: Olinvacimab
DrugBank: Olinvacimab (DB16265)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Treatment with Olinvacimab and Pembrolizumab is to be continued until disease progression, the development of unacceptable toxicity or patient's withdrawal of consent. Maximum duration of treatment will be 35 cycles (approximately 2 years).
Study: NCT05500092
Drug: Nivolumab
Normalized name: Nivolumab
DrugBank: Nivolumab (DB09035)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Patients randomized to the Nivolumab + Platinum Doublet Chemotherapy only arm will receive three cycles of nivolumab at a dose of 360 mg every three weeks along with a platinum-based chemotherapy doublet (cisplatin or carboplatin plus pemetrexed for adenocarcinoma, cisplatin or carboplatin plus docetaxel, paclitaxel, or gemcitabine for squamous NSCLC) with sub-ablative stereotactic radiation therapy (8 Gy x 3) directed at the primary lung tumor
Study: NCT05500092
Drug: Platinum Doublet
Normalized name: platinum
DrugBank: Platinum (DB12257)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Standard of care doublet platinum therapy
Study: NCT06052787
Drug: Cerebrolysin
Normalized name: cerebrolysin
DrugBank: Cerebrolysin (DB16599)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Cerebrolysin, a mixture of free amino acids and low molecular weight peptides, has a neurotrophic factor-like activity with immediate pleiotropic neuroprotective activity and long-term multimodal effects on endogenous post-lesional regulation. Cerebrolysin has been suggested to exert beneficial effects on neurobehavioural functions, cognitive performance , and neuro-motor recovery , as part of initial therapy in severe and moderate acute TBI.