Halozyme (RV7) Drug Pipeline
| Drug Name | Condition | Stage | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| 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 | ― |
| 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 | ― |
| 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 | phase1AndPhase2 | 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 | ― |
| 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 | ― |
| Eribulin Mesylate, Biologic: Pegylated Recombinant Human Hyaluronidase (Pegph20), Biologic: Pegylated Recombinant Human Hyaluronidase | Metastatic Breast Cancer | phase1AndPhase2 | 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 | ― |
| 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 | ― |
| 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 | ― |
| 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 | ― |
| 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 | ― |
| 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 | ― |
| Drug Name | Stage | Condition | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Testosterone Enanthate | Phase III | Hypogonadism, Male | Recruiting | 52 Week Study of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism | Nov 06, 2024 | ― |
| Sham Injection, Rapid Acting Insulin With Pre-Treatment Of Rhuph20 | Phase IV | Type 1 Diabetes Mellitus | 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 | ― |
| Leucovorin, Oxaliplatin, Cisplatin, Paclitaxel, 5-Fluorouracil (5-FU), Ramucirumab, Atezolizumab, Linagliptin, Cobimetinib, Pegylated Recombinant Human Hyaluronidase (Pegph20), Bl-8040, Tiragolumab | phase1AndPhase2 | Gastric Adenocarcinoma Or Gastroesophageal Junction Adenocarcinoma Or Esophageal Carcinoma | 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 | ― |
| Atezolizumab, Pegph20, Cis, Gem | Phase I | Cholangiocarcinoma Non-Resectable, Cholangiocarcinoma, Intrahepatic, Cholangiocarcinoma, Extrahepatic, Gallbladder Adenocarcinoma | 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 | ― |
| Eribulin Mesylate, Biologic: Pegylated Recombinant Human Hyaluronidase (Pegph20), Biologic: Pegylated Recombinant Human Hyaluronidase | phase1AndPhase2 | Metastatic Breast Cancer | 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 | ― |
| Gemcitabine, Nab-paclitaxel, Biological: Pegylated Recombinant Human Hyaluronidase (Pegph20) | Phase III | Pancreatic Ductal Carcinoma | 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 | ― |
| 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 | Phase I | Healthy, Hypercholesterolemia | Terminated | Pharmacokinetic and Pharmacodynamic Study of Bococizumab Alone and When Combined With Recombinant Human Hyaluronidase | Jan 06, 2016 | ― |
| Pembrolizumab, Pegph20 | Phase I | Gastric Cancer, Nsclc | Completed | A Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) With Pembrolizumab in Participants With Selected Hyaluronan High Solid Tumors | Aug 31, 2015 | ― |
| Docetaxel, Pegylated Recombinant Human Hyaluronidase Ph20 | Phase I | Non-small Cell Lung Cancer | 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 | ― |
| Insulin Lispro, Insulin Glulisine, Commercial Hylenex® Recombinant (Hyaluronidase Human Injection), Precommercial Hylenex Recombinant (Hyaluronidase Human Injection), Insulin Aspart | Phase IV | Type 1 Diabetes Mellitus | 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 | ― |
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
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 (DE:RV7) have in its pipeline
Halozyme DE:RV7 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, Atezolizumab, Pegph20, Cis, Gem, Eribulin Mesylate, Biologic: Pegylated Recombinant Human Hyaluronidase (Pegph20), Biologic: Pegylated Recombinant Human Hyaluronidase, Gemcitabine, Nab-paclitaxel, Biological: Pegylated Recombinant Human Hyaluronidase (Pegph20), 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, Pembrolizumab, Pegph20, Docetaxel, Pegylated Recombinant Human Hyaluronidase Ph20, Insulin Lispro, Insulin Glulisine, Commercial Hylenex® Recombinant (Hyaluronidase Human Injection), Precommercial Hylenex Recombinant (Hyaluronidase Human Injection), Insulin Aspart, Dexamethasone, Gemcitabine, Nab-paclitaxel, Enoxaparin, Pegph20, Insulin Lispro, Sham Injection, Insulin Aspart, Recombinant Human Hyaluronidase Ph20, Gemcitabine, Pegph20, Cinryze With Rhuph20, Insulin Lispro, Insulin Glargine, Insulin Glulisine, Insulin Aspart, Recombinant Human Hyaluronidase Ph20, Oral Rehydration Fluid, Isotonic Hydration Fluid And Recombinant Human Hyaluronidase, Rhuph20, Zoledronic Acid, Rhuph20, Insulin Lispro Injection, Rhuph20, Insulin Human Injection, Recombinant Human Hyaluronidase, Humalog, Humulin-R, Recombinant Human Hyaluronidase Ph20 (Rhuph20), Liquid Meal, Humalog, Humulin-R, Recombinant Human Hyaluronidase Ph20 (Rhuph20), Mitomycin C, Chemophase. These drug candidates are in various stages of clinical development as the company works toward FDA approval.