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Halozyme Therapeutics (HALO)
NASDAQ:HALO
Testosterone Enanthate
Hypogonadism, Male
Phase III
Recruiting
52 Week Study of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism
Nov 06, 2024
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Sham Injection, Rapid Acting Insulin With Pre-Treatment Of Rhuph20
Type 1 Diabetes Mellitus
Phase IV
Completed
A Study of Continuous Subcutaneous Insulin Infusion (CSII) Pump Function in Subjects With Type 1 Diabetes With Recombinant Human Hyaluronidase (rHuPH20)
Aug 13, 2018
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Leucovorin, Oxaliplatin, Cisplatin, Paclitaxel, 5-Fluorouracil (5-FU), Ramucirumab, Atezolizumab, Linagliptin, Cobimetinib, Pegylated Recombinant Human Hyaluronidase (Pegph20), Bl-8040, Tiragolumab
Gastric Adenocarcinoma Or Gastroesophageal Junction Adenocarcinoma Or Esophageal Carcinoma
Phase I/II
Active Not Recruiting
A Study of Multiple Immunotherapy-Based Treatment Combinations in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Cancer (G/GEJ) or Esophageal Cancer (Morpheus-Gastric and Esophageal Cancer)
Sep 11, 2017
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Atezolizumab, Pegph20, Cis, Gem
Cholangiocarcinoma Non-Resectable, Cholangiocarcinoma, Intrahepatic, Cholangiocarcinoma, Extrahepatic, Gallbladder Adenocarcinoma
Phase I
Terminated
Study of PEGPH20 With Cisplatin (CIS) and Gemcitabine (GEM); PEGPH20 With Atezolizumab (ATEZO), CIS, and GEM; and CIS and GEM Alone in Participants With Previously Untreated, Unresectable, Locally Advanced, or Metastatic Intrahepatic and Extrahepatic Cholangiocarcinoma and Gallbladder Adenocarcinoma
Jul 25, 2017
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Eribulin Mesylate, Biologic: Pegylated Recombinant Human Hyaluronidase (Pegph20), Biologic: Pegylated Recombinant Human Hyaluronidase
Metastatic Breast Cancer
Phase I/II
Terminated
Study of Eribulin Mesylate in Combination With PEGylated Recombinant Human Hyaluronidase (PEGPH20) Versus Eribulin Mesylate Alone in Subjects With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative, High-Hyaluronan (HA) Metastatic Breast Cancer (MBC)
Apr 26, 2016
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Gemcitabine, Nab-paclitaxel, Biological: Pegylated Recombinant Human Hyaluronidase (Pegph20)
Pancreatic Ductal Carcinoma
Phase III
Terminated
A Study of PEGylated Recombinant Human Hyaluronidase in Combination With Nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus Nab-Paclitaxel and Gemcitabine in Participants With Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma
Mar 17, 2016
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Cohort 1: Bococizumab 150 Mg + Rhuph20, Cohort 2: Bococizumab 300 Mg, Cohort 3: Bococizumab 300 Mg + Rhuph20, Cohort 5: Bococizumab 450 Mg + Rhuph20, Cohort 4: Bococizumab 300 Mg + Rhuph20
Healthy, Hypercholesterolemia
Phase I
Terminated
Pharmacokinetic and Pharmacodynamic Study of Bococizumab Alone and When Combined With Recombinant Human Hyaluronidase
Jan 06, 2016
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Pembrolizumab, Pegph20
Gastric Cancer, Nsclc
Phase I
Completed
A Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) With Pembrolizumab in Participants With Selected Hyaluronan High Solid Tumors
Aug 31, 2015
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Docetaxel, Pegylated Recombinant Human Hyaluronidase Ph20
Non-small Cell Lung Cancer
Phase I
Terminated
A Phase 1b Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) Combined With Docetaxel in Subjects With Recurrent Previously Treated Locally Advanced or Metastatic NSCLC
Jan 15, 2015
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Insulin Lispro, Insulin Glulisine, Commercial Hylenex® Recombinant (Hyaluronidase Human Injection), Precommercial Hylenex Recombinant (Hyaluronidase Human Injection), Insulin Aspart
Type 1 Diabetes Mellitus
Phase IV
Completed
CONSISTENT 1: Metabolic and Safety Outcomes of Hylenex Recombinant (Hyaluronidase Human Injection) Preadministered at CSII Infusion Site in Participants With Type 1 Diabetes Mellitus (T1DM)
Apr 29, 2013
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Halozyme Therapeutics (HALO) have in its pipeline
HALO is currently developing the following drugs: Testosterone Enanthate, Sham Injection, Rapid Acting Insulin With Pre-Treatment Of Rhuph20, Leucovorin, Oxaliplatin, Cisplatin, Paclitaxel, 5-Fluorouracil (5-FU), Ramucirumab, Atezolizumab, Linagliptin, Cobimetinib, Pegylated Recombinant Human Hyaluronidase (Pegph20), Bl-8040, Tiragolumab. These drug candidates are in various stages of clinical development as the company works toward FDA approval.