non-narcotic analgesic
Opiranserin (VVZ-149)
VVZ-149
Opiranserin VVZ-149 for injection
Opiranserin (VVZ-149) for injection is a first-in-class non-narcotic analgesic under development by Vivozon. As a treatment for postoperative pain used as a first-line therapy in the global market, Opiranserin aims to ultimately replace opioid analgesics by providing an effective and safe solution for pain management. With the hope to combat opioid misuse and abuse, Opiranserin is currently undergoing phase 3 clinical trials in Korea and the United States.
- Competitive advantages
-
Among the non-narcotic analgesics under development, it ranks among the top in terms of efficacy, safety, and development stages.
Anticipated analgesic efficacy comparable or superior to that of opioids
Excellent safety: Overcoming the side effects of opioid analgesics and anti-inflammatory drugs
Rapid postoperative pain management, systemic administration, analgesic efficacy in opioid-tolerant patients
- How it works
-
It is a multi-target new drug that simultaneously acts on GlyT2 and 5HT2a, which are involved in the generation, transmission, and regulation of pain signals. It exerts analgesic effects upon both the central nervous system and the peripheral nervous system.
In particular, it has a synergistic effect of analgesic efficacy by simultaneously inhibiting two targets in the spinal cord, which is a key area that regulates pain signals going up to the brain.
Read more
- Commercialization plans
-
Primary objective
Reduction of opioid use through the analgesic effect of Opiranserin
Confirmed opioid reduction of at least 30-50%
Ultimate goal
Replacement of narcotic analgesic use after surgery and opioid use during surgery
Expected to be used as a first-in-line treatment for pain before and after surgery
Clinical Development of Opiranserin for injection
CT.gov = ClinicalTrials.gov
-
PT-VVZ149-01
Completed
Phase 1
Korea
- CT.gov
- NCT01905410
- CRIS
- KCT0000792
PT-VVZ149-01
A randomized, double-blind, placebo-controlled, single and repeated dose, escalation clinical trial to evaluate the safety, tolerability, and pharmacokinetics of VVZ-149 injection in healthy adult males
-
PT-VVZ149-02
Completed
Phase 1
Korea
- CT.gov
- NCT02333318
- CRIS
- KCT0001345
PT-VVZ149-02
Single-dose, escalation clinical trial to evaluate the safety and pharmacokinetics of VVZ-149 injection in healthy elderly men
-
PT-VVZ149-04
Completed
Phase 2
Korea
- CT.gov
- NCT02522598
- CRIS
- KCT0001620
PT-VVZ149-04
A randomized, double-blind, parallel-group, placebo-controlled clinical trial to evaluate the analgesic efficacy and safety of VVZ-149 Injection in patients who have pain after laparoscopic gastrectomy in early gastric cancer patients
-
PT-VVZ149-05
Completed
Phase 2
Korea
- CT.gov
- NCT02844725
- CRIS
- KCT0002075
PT-VVZ149-05
A randomized, double-blind, parallel-group, placebo-controlled clinical trial to evaluate the analgesic efficacy and safety of VVZ-149 Injection in patients who have pain after laparoscopic and robotic-laparoscopic gastrectomy.
-
PT-VVZ149-06
Completed
Phase 2
Korea
- CT.gov
- NCT03347266
- CRIS
- KCT0002653
PT-VVZ149-06
A randomized, double-blind, parallel group, placebo-controlled clinical trial to evaluate the analgesic efficacy and safety of VVZ-149 Injection in patients who have pain after artificial hip replacement surgery.
-
VVZ149-POP-P3-K301
Completed
Phase 3
Korea
- CT.gov
- NCT05764525
- CRIS
- KCT0007551
VVZ149-POP-P3-K301
A multicenter, randomized, double-blind, parallel-group, placebo-controlled phase 3 clinical trial to evaluate the analgesic efficacy and safety of VVZ-149 injection in patients who have pain after laparoscopic colectomy.
-
VVZ149-POP-P2-US001
Completed
Phase 2
USA
- CT.gov
- NCT02489526
- CRIS
- -
VVZ149-POP-P2-US001
A Randomized, double-blind, parallel group, placebo-controlled study to evaluate the analgesic efficacy and safety of VVZ-149 injections for post-operative pain following laparoscopic colorectal surgery.
-
VVZ149-POP-P2-US002
Completed
Phase 2
USA
- CT.gov
- NCT02992041
- CRIS
- -
VVZ149-POP-P2-US002
Analgesic efficacy and safety of VVZ-149 injections for post-operative pain following laparoscopic colorectal surgery: a randomized, double-blind, parallel group, placebo-controlled, dose finding study.
-
2015-P-002050
Completed
Phase 1b
USA
- CT.gov
- NCT02644421
- CRIS
- -
2015-P-002050
Phase Ib randomized, double-blind, latin square crossover, clinical trial to evaluate the safety and analgesic efficacy of VVZ-149. Lidocaine v. placebo in lumbar radiculopathy
-
VVZ149-POP-P3-US003
Completed
Phase 3
USA
- CT.gov
- NCT03997838
- CRIS
- -
VVZ149-POP-P3-US003
A multicenter, randomized, double-blind, parallel group, placebo-controlled trial to evaluate the safety and efficacy of VVZ-149 injections for the treatment of postoperative pain following abdominoplasty
-
VVZ149-POP-P2-US004
Completed
Phase 2
USA
- CT.gov
- NCT03997812
- CRIS
- -
VVZ149-POP-P2-US004
A multicenter, randomized, double-blind, parallel group, placebo-controlled trial to evaluate the efficacy and safety of VVZ-149 injections for the treatment of postoperative pain following bunionectomy
-
VVZ149-POP-P3-US005
In progress
Phase 3
USA
- CT.gov
- NCT04430088
- CRIS
- -
VVZ149-POP-P3-US005
A phase 3, multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of VVZ-149 injections for the treatment of postoperative pain following bunionectomy
Opiranserin VVZ-149 for external use
Opiranserin (VVZ-149) for external use is a topically applied external analgesic based on the peripheral sensitization of Opiranserin. Along with the development of Opiranserin for injection, it is being developed with a goal of achieving superior analgesic effects compared to existing anti-inflammatory topical treatments. Phase 2 clinical trials in progress in Korea.
Clinical Development of Opiranserin for external use
CT.gov = ClinicalTrials.gov
-
VVZ149-EXT-P2-K007
Completed
Phase 2a
Korea
- CT.gov
- -
- CRIS
- -
VVZ149-EXT-P2-K007
Randomized, double-blind, parallel-group, placebo-controlled clinical trial to evaluate the safety and preliminary efficacy of Opiranserin gel in patients who have myofascial pain syndrome and fibromyalgia
-
VVZ149-EXT-P2-K009
In progress
Phase 2
Korea
- CT.gov
- -
- CRIS
- KCT0007704
VVZ149-EXT-P2-K009
A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate Analgesic Efficacy and Safety of Opiranserin Cream for Myofascial pain syndrome
Risk of opioid analgesics
with no alternative
As the number of deaths due to the misuse of opioids, narcotic painkillers, continues to rise, the United States, the world’s largest medical market, has started strongly regulating opioids, resulting in companies filing for bankruptcy. Although a major change is beginning to be made in the market with this strong opioid regulation, there is still no effective non-narcotic analgesic available to replace opioids, so there is a huge unmet need in the pain therapeutics.
The market value
of Opiranserin
is limitless
Global
analgesic
market
The analgesic market is the second-largest market after anticancer drugs. Nevertheless, current analgesics are classified only as ▲narcotic analgesics with potent analgesic effects but risk of addiction or ▲non-narcotic analgesics (mainly anti-inflammatory analgesics) that are not addictive but act only on mild pain. Therefore, the unmet need of the market is huge.
Opioid analgesics have the most potent effects and are used for severe pain, but most have serious side effects, including vomiting and nausea and possibly death with prolonged use. Therefore, many patients are reluctant, and clinicians prefer not to prescribe these because their use is limited. Another major drawback is that results are insufficient for chronic pain types such as neuropathic pain. Non-narcotic analgesics (mainly anti-inflammatory analgesics) are used in combination with narcotic analgesics because their efficacy is weak when used alone, but these cannot be used continuously due to side effects.
Efforts are continuing to reduce the use of opioids in the US and worldwide analgesic markets because of the many side effects. The reason opioid analgesics continue to be used despite serious side effects is that there are no alternatives. If a new analgesic drug with comparable efficacy to opioid analgesics but fewer side effects is developed, it will lead to a huge analgesic market by satisfying unmet medical needs and contributing to human health.
The analgesic market is expected to grow rapidly to a market size of $91.6 billion (104.4 trillion won) in 2024, with a CAGR of more than 5%. The postoperative pain market is expected to grow at a high CAGR of 5.3% and reach a market size of 42 billion dollars (47.9 trillion won) in 2024. To the same extent, the market value of Opiranserin is also expected to rise sharply.
Global
analgesic
market