First-in-class

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.

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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