Delving into the Latest Updates on Tilidine Hydrochloride/Naloxone with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

复方盐酸替利定, 盐酸替利定/纳洛酮

Target

Opioid receptors x μ opioid receptor

Mechanism

Opioid receptors agonists(Opioid receptors agonists), μ opioid receptor antagonists(Mu opioid receptor antagonists)

Therapeutic Areas

Nervous System DiseasesSkin and Musculoskeletal Diseases

Active Indication

Cancer PainAcute PainArthralgia+ [5]

Inactive Indication-

Originator Organization

Hebei Aoxing Group Pharmaceutical Co. Ltd.

Active Organization

Hebei Aoxing Group Pharmaceutical Co. Ltd.

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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Structure

Molecular FormulaC19H21NO4

InChIKeyUZHSEJADLWPNLE-GRGSLBFTSA-N

CAS Registry465-65-6

View All Structures (2)

According to relevant requirements, the pharmacokinetic study of multiple-dose oral administration of compound tilidine hydrochloride capsules developed by Hebei Aoxing Group Pharmaceutical Co., Ltd. in vivo was conducted in patients with cancer pain. The research content included pharmacokinetic study of multiple-dose administration, safety evaluation and efficacy evaluation.

Start Date02 Aug 2013

Sponsor / Collaborator

Hebei Aoxing Group Pharmaceutical Co. Ltd.

CTR20130620 / RecruitingPhase 1

采用无对照开放、单剂量顺序给药的研究方法评价复方盐酸替利定口服溶液的药代动力学特性

[Translation] Evaluation of the pharmacokinetic properties of compound tilidine hydrochloride oral solution by an uncontrolled open-label, single-dose sequential administration study

本试验的目的是评价四川抗菌素工业研究所有限公司和国药集团工业有限公司廊坊分公司共同研制的复方盐酸替利定口服溶液人体药代动力学特性及安全性，为临床安全、合理用药提供参考依据。

[Translation]

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety of the compound tilidine hydrochloride oral solution jointly developed by Sichuan Antibiotics Industrial Research Institute Co., Ltd. and Sinopharm Group Industrial Co., Ltd. Langfang Branch in humans, and to provide a reference for safe and rational clinical use of drugs.

Start Date09 Mar 2013

Sponsor / Collaborator

Sichuan Antimicrobial Industry Research Institute

[+1]

100 Clinical Results associated with Tilidine Hydrochloride/Naloxone

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100 Translational Medicine associated with Tilidine Hydrochloride/Naloxone

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100 Patents (Medical) associated with Tilidine Hydrochloride/Naloxone

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3

Literatures (Medical) associated with Tilidine Hydrochloride/Naloxone

14 Sep 2006·MMW Fortschritte der Medizin

[Tilidine-Naloxone sustained-release tablets for chronic pain associated with musculoskeletal disease].

Author: Tilke, C ; Sarnow, E ; Junker, U

30 Sep 1995·Fortschritte der Medizin

[Long-term treatment of chronic pain with tilidine-naloxone. An analysis of 50 patients with chronic pain conditions of non-malignant origin].

Article

Author: Wörz, R ; Wörz, E

METHOD50 patients with incurable chronic pain states were treated for a period of between six months and 14 years (median: 31 months) with tilidine-naloxone, and the results of tumor recorded. Amelioration of pain was achieved in an average of 60.7% of the cases. The 16 patients of this series suffering from neuropathic pain who received a somewhat lower dose responded equally as well (60.3% amelioration) as the overall group. In 24 patients suffering from pain, the daily dose remained unchanged throughout the course of treatment, had to be increased in 19, and was reduced in seven patients. In two patients, acceptable side-effects were indicated; in no case were there any signs of drug-induced organic damage.CONCLUSIONSThe results show that tilidine-naloxone is a highly effective opioid analgesic with a remarkably favorable benefit-risk ratio for use in long-term treatment.

01 Jan 1992·International journal of clinical pharmacology research

Comparative study of tilidine-naloxone and pentazocine in knee and hip osteoarthritis.

Article

Author: Van Cauwenberge, H ; Ruhwiedel, M ; Franchimont, P ; Albert, A

Fifty patients, twenty-five suffering from severe knee osteoarthritis and twenty-five from acute hip osteoarthritis, received pentazocine or a new preparation of tilidine-naloxone for a period of 2 weeks, in a double-blind study. The two drugs were found to have the same efficacy and tolerance in both diseases with a minor but not statistically significant superiority for tilidine-naloxone. Similar quantities of drugs were taken over the study period, while patients were allowed to take as many as 8 capsules per day to relieve pain. There were quite equivalent side-effects and no marked changes in laboratory tests.

100 Deals associated with Tilidine Hydrochloride/Naloxone

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Cancer Pain	Phase 2	CN	Hebei Aoxing Group Pharmaceutical Co. Ltd.	12 Aug 2013
Acute Pain	Phase 2	CN	Hebei Aoxing Group Pharmaceutical Co. Ltd.	28 Mar 2011
Arthralgia	Phase 2	CN	Hebei Aoxing Group Pharmaceutical Co. Ltd.	28 Mar 2011
Chronic Pain	Phase 2	CN	Hebei Aoxing Group Pharmaceutical Co. Ltd.	28 Mar 2011
Moderate pain	Phase 2	CN	Hebei Aoxing Group Pharmaceutical Co. Ltd.	28 Mar 2011
Neuralgia	Phase 2	CN	Hebei Aoxing Group Pharmaceutical Co. Ltd.	28 Mar 2011
Post-traumatic pain	Phase 2	CN	Hebei Aoxing Group Pharmaceutical Co. Ltd.	28 Mar 2011
Severe pain	Phase 2	CN	Hebei Aoxing Group Pharmaceutical Co. Ltd.	28 Mar 2011