ThyroLDN: a phase 2, double blind, randomised controlled trial of low dose naltrexone on thyroid-specific quality of life in Hashimoto’s thyroiditis patients with residual hypothyroid symptoms despite optimal thyroid hormone replacement.

Start Date01 Jun 2025

Sponsor / Collaborator-

NCT05382091

/ Not yet recruitingPhase 2

A Phase II Multi-Center Safety Study Examining the Use of the O'Neil Long Acting Naltrexone Implant (OLANI) in Opioid Dependent Persons Receiving Repeat Dosing

This study will examine the safety and efficacy of the O'Neil Long Acting Naltrexone Implant (OLANI) in persons with opioid dependency who are seeking relapse-prevention treatment. All participants will be treated in an open label manner. No randomization will occur. The OLANI is a long-acting biodegradable form of naltrexone which is implanted in the abdominal region. It is hypothesized that the OLANI will produce blood levels sufficient to block the effects of opioids for an extended period allowing patients to engage in psychosocial treatment and recovery over the long term. After the initial set of implants, participants will be offered 3 sets of single implants 13 weeks, each with an acceptable window of 12-16 weeks after the previous dose.

Start Date15 Mar 2025

Sponsor / Collaborator

Go Medical Industries Pty Ltd.

[+5]

NCT05363514

/ Not yet recruitingPhase 4IIT

A Pilot Study of Low Dose Naltrexone Use in Patients With Postural Orthostatic Tachycardia Syndrome

Many patients with Postural Orthostatic Tachycardia Syndrome (POTS) experience debilitating fatigue and this significantly impacts their daily lives. Unfortunately, there are no treatments to help POTS patients with their fatigue. One medication, called low dose naltrexone (LDN), has been tested as a treatment for fatigue in other medical conditions. In this other research, LDN helped patients feel less fatigue. Other research studies have shown that LDN can help reduce markers of inflammation called cytokines. Reducing these cytokines could help reduce symptoms as well. There have been no research studies testing LDN in POTS to date. We are planning to do a research study to test LDN as a treatment to see if it helps POTS patients feel less fatigue.

Start Date01 Jan 2025

Sponsor / Collaborator

University of Calgary

100 Clinical Results associated with Naltrexone Hydrochloride

100 Translational Medicine associated with Naltrexone Hydrochloride

100 Patents (Medical) associated with Naltrexone Hydrochloride

4,824

Literatures (Medical) associated with Naltrexone Hydrochloride

01 Jun 2025·FOOD CHEMISTRY

High-throughput screening of new psychoactive substances and related compounds in food by UHPLC-Q/Orbitrap

Article

Author: Huang, Xia ; Wan, Yuping ; Shi, Peiyu ; Wu, Wenlin ; Xiao, Quanwei ; Liu, Shiyao ; Guo, Tianrong ; Zhang, Min ; Xia, Bing ; Zhou, Yan ; Chen, Xiaoqi

Currently, there is concern about food products to which new psychoactive substances (NPS) have been added illegally. However, rapid, high-sensitivity, and high-throughput screening methods for such harmful substances have not been reported yet. In this study, a high-throughput non-targeted screening strategy was developed based on UHPLC-Q/Orbitrap. First, optimized pretreatment methods for typical high-risk matrices were established. Second, an accurate, efficient, and scalable high resolution mass spectrometry database containing 206 NPS and related compounds was constructed. The fragmentation pathways of three different types of fentanyl-related compounds were then systematically investigated to enhance compound identification. Additionally, a non-targeted screening strategy was developed using warning ions derived from 24 fentanyl-related compounds, streamlining the identification of NPS. This strategy was applied to 100 food samples with possible illegal additives and demonstrated its effectiveness. In summary, this study provides robust technical support for regulatory authorities in combating the illegal addition of food products.

01 May 2025·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

LC-MS/MS method for the simultaneous quantification of thiafentanil and naltrexone in bovine muscle, liver and kidney

Article

Author: Kellermann, Tracy ; Laurence, Michael ; Bruce, Mieghan ; Christie, Judith T ; Pfitzer, Silke ; Raath, Jacobus P ; Laubscher, Liesel

Thiafentanil is a µ-opioid agonist used for the chemical immobilisation of a variety of ungulate species and is antagonised by the administration of naltrexone. The potential for these ungulates to be hunted for consumption by humans or predators raises concerns of drug residues in animal tissues. No analytical method to quantify tissue residue concentrations of thiafentanil has been previously reported. This research developed an LC-MS/MS method to quantify thiafentanil in bovine muscle, and both thiafentanil and naltrexone in bovine liver and kidney matrices. The analytical method was applied to quantify tissue residues in samples collected from goats 1, 2, 3, and 6 days post thiafentanil administration. The assay was validated over the calibration range 6.25-200 ng/mg for thiafentanil in muscle, and 3.13-400 ng/mg for thiafentanil and 57.8-7400 ng/mg for naltrexone in liver and kidney. No residues above the lowest limit of quantification were detected in the injection site, longissimus dorsi muscle, liver or kidney samples collected from the goats. The reported analytical method and residue depletion data provide a foundation for future thiafentanil and naltrexone residue depletion studies in wildlife species.

01 May 2025·Contemporary Clinical Trials

Changes in mental health during long-term treatment with extended-release naltrexone: A 3-year clinical study of opioid dependent individuals

Article

Author: Digranes, Linn Camilla Wergeland ; Holtan, Line ; Kunoe, Nikolaj ; Tanum, Lars ; Benth, Jūratė Šaltytė ; Solli, Kristin Klemmetsby

BACKGROUND:

Mental health status may be improved in patients receiving treatment with the opioid antagonist extended-release naltrexone (XR-NTX), but longer-term outcomes remain unexamined.

OBJECTIVES:

This study aims to assess changes in symptoms of anxiety, depression, and insomnia among opioid-dependent individuals in long-term treatment with XR-NTX and to explore possible associations between such symptoms and the use of illicit opioids.

METHODS:

After completing an initial 3-month randomized clinical trial and an extended 9-month follow-up study, 50 opioid-dependent individuals (9 women) chose to continue treatment with XR-NTX at their own discretion for a prolonged period of up to 2 years. Symptoms of anxiety, depression, and insomnia were assessed every 4th week. In addition, the participants reported use of illicit opioids.

RESULTS:

The participants reported improved mental health status during up to 3 years treatment with XR-NTX. Symptoms of anxiety and depression were reduced from mean 18.0 (SD:6.1) to 12.3 (SD:4.4) (p < 0.001), and from 30.5 (SD:9.1) to 17.8 (SD:5.4) (p < 0.01), respectively, whereas symptoms of insomnia were reduced from 14.2 (SD:7.9) to 3.6 (SD:3.6), (p < 0.001). The reduction in these symptoms was more pronounced in participants who did not relapse to opioid use (n = 35) during the study.

CONCLUSION:

Long-term treatment with XR-NTX may promote a reduction in symptoms of anxiety, depression, and insomnia in opioid-dependent individuals. Those who managed to stay abstinent from opioids were likelier to experience a greater reduction in symptoms compared to those who relapsed to opioid use during the 3-year treatment period.

CLINICALTRIALS:

gov no. NCT01717963.

184

News (Medical) associated with Naltrexone Hydrochloride

11 Apr 2025

·www.globenewswire.com

Scilex Holding Company Announces 1-for-35 Reverse Stock Split

PALO ALTO, Calif., April 11, 2025 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain and, following the formation of its proposed joint venture with IPMC Company, neurodegenerative and cardiometabolic disease, today announced that it will effect a reverse stock split of its outstanding shares of common stock at a ratio of 1-for-35, to be effective as of 12:01 a.m. Eastern Time on April 15, 2025. Scilex’s common stock will begin trading on a reverse stock split-adjusted basis at the opening of the market on April 15, 2025. Following the reverse stock split, Scilex’s common stock will continue to trade on The Nasdaq Capital Market under the symbol “SCLX” with the new CUSIP number, 80880W 205. The reverse stock split is intended for Scilex to regain compliance with the minimum bid price requirement of $1.00 per share of common stock for continued listing on The Nasdaq Capital Market. The reverse stock split will not change the authorized number of shares of Scilex’s common stock. No fractional shares will be issued in connection with the reverse stock split, and stockholders who would otherwise be entitled to receive a fractional share in connection with the reverse stock split will instead receive a cash payment in lieu thereof equal to such fraction multiplied by the closing sales price of Scilex’s common stock as reported on The Nasdaq Capital Market on April 14, 2025. In addition, the reverse stock split will apply to Scilex’s common stock issuable (or deemed issuable, as applicable) upon the exercise or conversion, as applicable, of certain of Scilex’s outstanding warrants, shares of Series A Preferred Stock, convertible notes and stock options, with proportionate adjustments to be made to the exercise and conversion prices thereof, in each case in accordance with the respective terms of such warrants, shares of Series A Preferred Stock, convertible notes and stock options (and the applicable equity incentive plans). The reverse stock split will reduce the number of issued and outstanding shares of Scilex’s common stock from approximately 243 million to approximately 6.9 million. At Scilex’s special meeting of stockholders held on March 19, 2025, Scilex’s stockholders approved the reverse stock split in connection with Scilex’s common stock and gave Scilex’s board of directors discretionary authority to select a ratio for the reverse stock split ranging from 1-for-14 shares to 1-for-50 shares. Scilex’s board of directors approved the reverse stock split at a ratio of 1-for-35 on April 3, 2025. Continental Stock Transfer & Trust Company is acting as the exchange agent and paying agent for the reverse stock split. Stockholders holding their shares in book-entry form or in brokerage accounts need not take any action in connection with the reverse stock split. Continental Stock Transfer & Trust Company will provide instructions to any stockholders with certificates regarding the process in connection with the exchange of pre-reverse stock split stock certificates for ownership in book-entry form or stock certificates on a post-reverse stock split basis. Stockholders are encouraged to contact their bank, broker or custodian with any procedural questions. For more information on Scilex Holding Company, refer to www.scilexholding.com For more information on Semnur Pharmaceuticals, Inc., refer to www.semnurpharma.com For more information on ZTlido® including Full Prescribing Information, refer to www.ztlido.com. For more information on ELYXYB®, including Full Prescribing Information, refer to www.elyxyb.com. For more information on Gloperba®, including Full Prescribing Information, refer to www.gloperba.com. https://www.facebook.com/scilex.pharm https://www.linkedin.com/company/scilex-holding-company/ info@scilexholding.com About Scilex Holding Company Scilex Holding Company is an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain and, following the formation of its proposed joint venture with IPMC Company, in neurodegenerative and cardiometabolic disease. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with acute and chronic pain and is dedicated to advancing and improving patient outcomes. Scilex’s commercial products include: (i) ZTlido® (lidocaine topical system) 1.8%, a prescription lidocaine topical product approved by the U.S. Food and Drug Administration (the “FDA”) for the relief of neuropathic pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain; (ii) ELYXYB®, a potential first-line treatment and the only FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults; and (iii) Gloperba®, the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults. In addition, Scilex has three product candidates: (i) SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXA” or “SP-102”), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, for which Scilex has completed a Phase 3 study and was granted Fast Track status from the FDA in 2017; (ii) SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a next-generation, triple-strength formulation of ZTlido, for the treatment of acute pain and for which Scilex has recently completed a Phase 2 trial in acute low back pain. SP-103 has been granted Fast Track status from the FDA in low back pain; and (iii) SP-104 (4.5 mg, low-dose naltrexone hydrochloride delayed-release capsules) (“SP-104”), a novel low-dose delayed-release naltrexone hydrochloride being developed for the treatment of fibromyalgia. Scilex Holding Company is headquartered in Palo Alto, California. About Semnur Pharmaceuticals, Inc. Semnur Pharmaceuticals, Inc. (“Semnur”), a wholly-owned subsidiary of Scilex, is a clinical late-stage specialty pharmaceutical company focused on the development and commercialization of novel non-opioid pain therapies. Semnur’s product candidate, SP-102 (SEMDEXA™), is the first non-opioid novel gel formulation administered epidurally in development for patients with moderate to severe chronic radicular pain/sciatica. Semnur Pharmaceuticals, Inc. is headquartered in Palo Alto, California Forward-Looking Statements This press release and any statements made for and during any presentation or meeting concerning the matters discussed in this press release contain forward-looking statements related to Scilex and its subsidiaries under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding Scilex’s ability to regain or remain in compliance with the continued listing standards of Nasdaq, Scilex’s proposed joint venture with IPMC Company and the potential development and commercialization of treatments for obesity, neurodegenerative, cardiometabolic disease. Risks and uncertainties that could cause Scilex’s actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: Scilex’s ability to consummate a joint venture or any other transaction with IPMC Company and develop and commercialize treatments for obesity, neurodegenerative, cardiometabolic disease; risks associated with the unpredictability of trading markets and whether a market will be established for Scilex’s common stock; general economic, political and business conditions; risks related to COVID-19 (and other similar disruptions); the risk that the potential product candidates that Scilex develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Scilex’s product candidates; the risk that Scilex will be unable to successfully market or gain market acceptance of its product candidates; the risk that Scilex’s product candidates may not be beneficial to patients or successfully commercialized; the risk that Scilex has overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe these therapies; risks that the outcome of the trials and studies for SP-102, SP-103 or SP-104 may not be successful or reflect positive outcomes; risks that the prior results of the clinical and investigator-initiated trials of SP-102 (SEMDEXA™), SP-103 or SP-104 may not be replicated; regulatory and intellectual property risks; and other risks and uncertainties indicated from time to time and other risks described in Scilex’s most recent periodic reports filed with the Securities and Exchange Commission, including Scilex’s Annual Report on Form 10-K for the year ended December 31, 2024 and subsequent Quarterly Reports on Form 10-Q that the Company has filed or may file with the SEC, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and Scilex undertakes no obligation to update any forward-looking statement in this press release except as may be required by law. Contacts:Investors and MediaScilex Holding Company 960 San Antonio RoadPalo Alto, CA 94303Office: (650) 516-4310 Email: investorrelations@scilexholding.com Website: www.scilexholding.com # # # SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc., a wholly-owned subsidiary of Scilex Holding Company. A proprietary name review by the FDA is planned. ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex Holding Company. Gloperba® is the subject of an exclusive, transferable license to use the registered trademark by Scilex Holding Company. ELYXYB® is a registered trademark owned by Scilex Holding Company. All other trademarks are the property of their respective owners. © 2025 Scilex Holding Company All Rights Reserved.

Fast TrackPhase 2Phase 3Drug ApprovalLicense out/in

27 Mar 2025

·www.globenewswire.com

Scilex Holding Company Has Appealed Lower Court Decision to the U.S. Court of Appeals for the Federal Circuit in Washington, DC and Will Continue to Vigorously Pursue its Infringement Action Against Aveva

PALO ALTO, Calif., March 26, 2025 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain and, following the formation of its proposed joint venture with IPMC Company, in neurodegenerative and cardiometabolic disease, reiterates that it has appealed a lower court decision to the U.S. Court of Appeals for the Federal Circuit in Washington, DC and will continue to vigorously pursue its infringement action on appeal against Aveva Drug Delivery Systems, Inc. (“Aveva”). In May 2022, Scilex received notice that a pharmaceutical maker, Aveva and its former related entities, Apotex Corp. and Apotex Inc. (collectively, the “Apotex Parties”), had submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (“FDA”) and had filed a Paragraph IV notice, alerting both the FDA and Scilex that the proposed product may infringe Scilex’s ZTlido patents that are listed in the FDA’s “Approved Drug Products with Therapeutic Equivalence Evaluations” publication (the FDA’s “Orange Book”). In response, Scilex filed a patent infringement lawsuit against those parties in June 2022, in the U.S. District Court for the Southern District of Florida (the “District Court”), alleging infringement of Scilex’s Orange Book-listed patents covering ZTlido. The Apotex parties were later dismissed from the lawsuit. Following the trial in July 2024, the District Court found that the proposed product did not infringe Scilex’s patents. Scilex has appealed that decision to the U.S. Court of Appeals for the Federal Circuit in Washington, DC. Scilex intends to continue to vigorously pursue its infringement action on appeal. “We remain steadfast in our belief in the strength and validity of our ZTlido intellectual property and that Aveva is infringing on our patents. In light of the Court’s decision, we are pursuing an appellate review at the U.S. Court of Appeals for the Federal Circuit as warranted. We firmly believe we have built a strong portfolio of intellectual property and that the ZTlido franchise is well protected on multiple levels. The infringement suit is ongoing, and we have additional patents that are forthcoming for the follow-on programs,” said Jaisim Shah, President and Chief Executive Officer of Scilex. For more information on Scilex Holding Company, refer to www.scilexholding.com For more information on Semnur Pharmaceuticals, Inc., refer to www.semnurpharma.com For more information on ZTlido®, including Full Prescribing Information, refer to www.ztlido.com. For more information on ELYXYB®, including Full Prescribing Information, refer to www.elyxyb.com. For more information on Gloperba®, including Full Prescribing Information, refer to www.gloperba.com. https://www.facebook.com/scilex.pharm https://www.linkedin.com/company/scilex-holding-company/ info@scilexholding.com About Scilex Holding Company Scilex Holding Company is an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain and, following the formation of its proposed joint venture with IPMC Company, in neurodegenerative and cardiometabolic disease. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with acute and chronic pain and is dedicated to advancing and improving patient outcomes. Scilex’s commercial products include: (i) ZTlido® (lidocaine topical system) 1.8%, a prescription lidocaine topical product approved by the U.S. Food and Drug Administration (the “FDA”) for the relief of neuropathic pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain; (ii) ELYXYB®, a potential first-line treatment and the only FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults; and (iii) Gloperba®, the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults. In addition, Scilex has three product candidates: (i) SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXA” or “SP-102”), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, for which Scilex has completed a Phase 3 study and was granted Fast Track status from the FDA in 2017; (ii) SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a next-generation, triple-strength formulation of ZTlido, for the treatment of acute pain and for which Scilex has recently completed a Phase 2 trial in acute low back pain. SP-103 has been granted Fast Track status from the FDA in low back pain; and (iii) SP-104 (4.5 mg, low-dose naltrexone hydrochloride delayed-release capsules) (“SP-104”), a novel low-dose delayed-release naltrexone hydrochloride being developed for the treatment of fibromyalgia. Scilex Holding Company is headquartered in Palo Alto, California. About Semnur Pharmaceuticals, Inc. Semnur Pharmaceuticals, Inc. (“Semnur”), a wholly-owned subsidiary of Scilex, is a clinical late-stage specialty pharmaceutical company focused on the development and commercialization of novel non-opioid pain therapies. Semnur’s product candidate, SP-102 (SEMDEXA™), is the first non-opioid novel gel formulation administered epidurally in development for patients with moderate to severe chronic radicular pain/sciatica. Semnur Pharmaceuticals, Inc. is headquartered in Palo Alto, California Forward-Looking Statements This press release and any statements made for and during any presentation or meeting concerning the matters discussed in this press release contain forward-looking statements related to Scilex and its subsidiaries under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding the final outcome of the patent infringement lawsuit or the timing thereof, any additional patents that are forthcoming for the follow-on programs, Scilex’s proposed joint venture with IPMC Company and the potential development and commercialization of treatments for obesity, neurodegenerative, cardiometabolic disease. Risks and uncertainties that could cause Scilex’s actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: Scilex’s ability to obtain and maintain proprietary protection for its products, technology and know-how and to prevent others from infringing on its proprietary rights, Scilex’s ability to consummate a joint venture or any other transaction with IPMC Company and develop and commercialize treatments for obesity, neurodegenerative, cardiometabolic disease; risks associated with the unpredictability of trading markets and whether a market will be established for Scilex’s common stock; general economic, political and business conditions; the risk that the potential product candidates that Scilex develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Scilex’s product candidates; the risk that Scilex will be unable to successfully market or gain market acceptance of its product candidates; the risk that Scilex’s product candidates may not be beneficial to patients or successfully commercialized; the risk that Scilex has overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe these therapies; risks that the outcome of the trials and studies for SP-102, SP-103 or SP-104 may not be successful or reflect positive outcomes; risks that the prior results of the clinical and investigator-initiated trials of SP-102 (SEMDEXA™), SP-103 or SP-104 may not be replicated; regulatory and intellectual property risks; and other risks and uncertainties indicated from time to time and other risks described in Scilex’s most recent periodic reports filed with the Securities and Exchange Commission, including Scilex’s Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent Quarterly Reports on Form 10-Q that the Company has filed or may file with the SEC, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and Scilex undertakes no obligation to update any forward-looking statement in this press release except as may be required by law. Contacts: Investors and MediaScilex Holding Company 960 San Antonio RoadPalo Alto, CA 94303Office: (650) 516-4310 Email: investorrelations@scilexholding.com Website: www.scilexholding.com SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc., a wholly-owned subsidiary of Scilex Holding Company. A proprietary name review by the FDA is planned. ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex Holding Company. Gloperba® is the subject of an exclusive, transferable license to use the registered trademark by Scilex Holding Company. ELYXYB® is a registered trademark owned by Scilex Holding Company. All other trademarks are the property of their respective owners. © 2025 Scilex Holding Company All Rights Reserved.

Phase 2Phase 3Fast TrackLicense out/inDrug Approval

24 Mar 2025

·endpts.com

Tempero Bio, led by ex-Novartis execs, gets $70M to reduce substance use disorders

A small Oakland, CA-based biotech hoping to take on the sprawling landscape of substance use disorders and addiction has reeled in $70 million. The drug development startup, named Tempero Bio, secured the Series B to collect Phase 2 trial data for its daily pill called TMP-301. 8VC led the funding round, which was disclosed Monday morning. Other investors include founder Aditum Bio and Khosla Ventures. Tempero expects to have Phase 2 data in alcohol use disorder (AUD) toward the end of this year and mid-stage data in cocaine use disorder (CUD) around the middle of 2026, president and chief scientific officer Ricardo Dolmetsch told Endpoints News in an exclusive interview. The funding provides runway through 2027, he said. The AUD Phase 2 began late last year. The CUD proof-of-concept study will start this year after an ongoing drug-drug interaction study wraps up soon, Dolmetsch said. “It’s always been a giant unmet medical need. It’s highly stigmatized,” Dolmetsch said. “People have a lot of shame, and we devote a lot of resources to punishing people or trying to disincentivize them, but it doesn’t really solve the problem for the patient or for the family.” Dolmetsch, who left his CSO post at gene therapy maker uniQure in 2023, spent more than half a dozen years heading up global neuroscience drug development at Novartis. While there, he worked under the direction of then-CEO Joe Jimenez and Mark Fishman, who was president of the Novartis Institutes for BioMedical Research. Jimenez and Fishman reunited to form Aditum Bio, a biotech investor and incubator that sets up companies around clinical-stage assets or drugs about to enter human studies. They’re working out of their third fund, which closed at $428 million earlier this year. The former Novartis executives started Tempero around a licensing deal for an asset developed by Nxera (then known as Sosei Heptares) — a mGluR5 negative allosteric modulator called TMP-301. They’ve now brought in chief medical officer John Wagner, a former Takeda SVP and CMO at Koneksa, who is working on creating digital biomarkers for new drugs. It’s a sort of comeback story for Dolmetsch and the team. While at Novartis, Dolmetsch worked on a mGluR5 program called mavoglurant. They took the experimental medicine through a series of clinical studies in cocaine use disorder , obsessive-compulsive disorder, fragile X syndrome and Huntington’s disease. “That actually showed efficacy in a study in patients with cocaine use disorder,” Dolmetsch said. But “mavoglurant had its own limitations and also it was off patent.” Tempero hopes that by inhibiting mGluR5, they’ll be able to restore balance to the brain’s reward nucleus, which in turn would reduce cravings, increase enthusiasm for daily activities and hamper dysphoria, Dolmetsch said. With TMP-301, they have a new investigational pill in the class. Dolmetsch said TMP-301 is more potent and has better pharmacokinetics than mavoglurant, which is now housed at Stalicla, a small Swiss startup that in-licensed the program from Novartis for up to $270 million . Stalicla has said it has US government funding and can take mavoglurant into Phase 3 for cocaine use disorder. The company’s website is under construction and on Stalicla’s LinkedIn page, the startup says it is “now raising series C funding to advance both verticals,” referring to its work in both autism spectrum disorder and substance use disorder. Stalicla’s CEO, Lynn Durham, didn’t immediately respond to an Endpoints inquiry about the company’s status on Friday or last month. Other companies are exploring mGluR5 for various conditions, like Noema Pharma in trigeminal neuralgia and seizures in tuberous sclerosis complex, and Addex in post-stroke and traumatic brain injury recovery . In its Phase 2 AUD study, Tempero hopes to show a reduction in heavy use days, Dolmetsch said. The field has moved from abstinence being the main goal to harm reduction and harm mitigation, or the prevention of binging and daily drinking, the CSO said. The same goes with cocaine and other abused drugs, he added. Naltrexone, an AUD and opioid use disorder drug, can reduce drinking by about 10% but is not very well tolerated, Dolmetsch said. “This is an area sort of like obesity. The thing that is going to be transformative is something that has a really dramatic effect,” the Tempero executive said. “I don’t think the world really needs a medicine that just reduces your drinking a little bit or reduces your dysphoria a little bit or reduces your drug use a little bit.” “I’ve worked a lot of my life on addiction, and I found that people often recognize that it’s a big unmet need, and then very rapidly after that, they’re like, ‘Well, you know, but addicts don’t like taking their medicines,’ or ‘They like being addicts,'” Dolmetsch said. “There are many, many misconceptions about what it’s like to have one of these disorders.” The round took about eight months to come together and closed toward the end of 2024, he said, adding that it’s been difficult, historically, to garner investor and pharma interest in the addiction space. “It started off being really difficult, and then suddenly it became really easy,” Dolmetsch said. Part of that is likely due to the hype that has built up around the weight loss and diabetes medicines from Eli Lilly and Novo Nordisk for their potential in treating addiction, among other conditions. Jimenez’s Aditum had put about $25 million into Tempero prior to the Series B, the CSO added. Jimenez previously told Endpoints that he sees Tempero’s work in addiction paralleling that of the obesity drug market, which has taken off in recent years thanks to the success of the GLP-1 class. “I really believe that once we prove this can be a multibillion-dollar business, there’s going to be pharma companies that take a hard look at it,” Jimenez told Endpoints in October 2023. Dolmetsch said he could envision Tempero going all the way to the market on its own. “Given the relative absence of drugs in the addiction space, we think there’s a lot of enthusiasm for having fairly accelerated registration timelines,” he said. “There is a real potential to develop a company here that not only develops the medicines but also develops the infrastructure that allows you to treat people with substance use disorders,” he said. “And the post-Covid world is one where people are much more willing to go online and be connected to caregivers and get a prescription and then have their prescriptions sent home.” If approved, Dolmetsch pictures TMP-301 being a drug that people use for a certain period of time to reduce their alcohol or drug abuse to the point where they have a “better relationship” with substances, he said. Then, they could eventually be weaned off the medication. But it would likely depend on individual circumstances, as they don’t want people to relapse, the executive added.

Phase 2License out/in

100 Deals associated with Naltrexone Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D02095	Naltrexone Hydrochloride	N07BB04	DB00704

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Opium Dependence	China	Shenzhen Sciencare Medical Industries Co., Ltd.	25 Jun 2024
Heroin Dependence	Australia	Generic Health Pty Ltd.	31 Aug 2007
Alcoholism	United States	Teva Women's Health, Inc.	20 Nov 1984
Opioid-Related Disorders	United States	Teva Women's Health, Inc.	20 Nov 1984

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Unspecified drug dependence	Phase 3	United States	Alkermes, Inc.	01 May 2010
Alcohol Use Disorder	Phase 2	China	Shenzhen Sciencare Medical Industries Co., Ltd.	03 Apr 2023
Opioid abuse	Phase 2	United States	Alkermes, Inc.	01 Sep 2012
Crohn Disease	Phase 2	United States	Hershey Medical Center	01 Sep 2006
Inflammation	Phase 2	United States	Hershey Medical Center	01 Sep 2006
COVID-19	Phase 1	United States	Statera Biopharma, Inc.	05 Dec 2021
Inflammatory Bowel Diseases	Preclinical	China	Shenzhen Sciencare Medical Industries Co., Ltd.	27 Sep 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02461927 (CTgov)	Phase 1/2	Alcohol Use Disorder \| Depressive Disorder, Major	65	Naltrexone+Ketamine (Ketamine + Naltrexone)	ohuwbdtdzy = fkntvrmiut jvsgacjwzr (jcjvtjjpzh, rbsrmwfefu - zryhtvaftf) View more	-	10 Apr 2025
				Placebo+ketamine (Ketamine + Placebo)	ohuwbdtdzy = pznudloocn jvsgacjwzr (jcjvtjjpzh, cvsoxwlhyh - bywntafoag) View more
NCT04313972 (CTgov)	Phase 4	Cystitis, Interstitial \| Pain	3	low-dose naltrexone (Low-dose Naltrexone)	flfvghhfkk = ptzqdgmvle djqzezlkrx (ohlvmjkrte, kwgzzntwuq - xdigffjlhj) View more	-	07 Mar 2025
				Placebo oral tablet (Placebo)	flfvghhfkk = ocsorltbqe djqzezlkrx (ohlvmjkrte, gozccdgmcf - damoylovum) View more
NCT04139668 (CTgov)	Phase 2	Cannabis withdrawal	1	Cognitive Behavioral Therapy+Naltrexone 380 MG [Vivitrol]	sgkeehohsm = nkqtlypyof lqtrwxikhi (hotxazkndp, kjowyhncvn - tnbyjvyusb) View more	-	07 Feb 2025
P6-12.008 (AAN2024)	Not Applicable	Migraine Disorders \| Fibromyalgia	42	Low-dose Naltrexone 4.5mg	jemsokmdse(tyiscxwfib) = iyyongjtcc fwwxyujgdr (wqcrokgioe )	Positive	09 Apr 2024
NCT04854551 (CTgov)	Phase 1/2	-	13	Naltrexone (Naltrexone)	oguwkfvypy(mfofgcxciy) = dwzgfydqte wpgzfpkkbc (bbgrxzlnvv, 0.09) View more	-	28 Nov 2023
				Placebo (Placebo)	oguwkfvypy(mfofgcxciy) = kktmhuzbcl wpgzfpkkbc (bbgrxzlnvv, 0.10) View more
NCT03447743 (CTgov)	Early Phase 1	Opioid abuse \| Opium Dependence	9	XR-NTX community location	gcrycmmozk = rhmlekbznd pkgehoztbf (curfllbpek, hyureivzqp - ljquwomvmq) View more	-	27 Mar 2023
AAD2023	Not Applicable	Pseudopelade	46	Low-dose oral naltrexone	dfoyazfsnt(fwonpebzqp) = Side effects were reported by 21.7% of patients and included insomnia, vivid dreams, and gastrointestinal upset. ryajwqclfm (cqicjmokzc )	-	17 Mar 2023
NCT04052139 (UH3, CTgov)	Phase 2	Alcohol Use Disorder \| Inflammation \| HIV Infections ... View more	45	Low-dose naltrexone (Low-dose Naltrexone)	gszrtlsura(mzculgddqi) = sxtvdudwgp aqemtupkxj (jbdxbbdglw, 0.63) View more	-	10 Nov 2022
				Gabapentin (Gabapentin)	gszrtlsura(mzculgddqi) = wbdyjwnuug aqemtupkxj (jbdxbbdglw, 0.38) View more
NCT03810495 (CTgov)	Phase 1	Opioid abuse	20	naltrexone implant	apqviucixl = jfuqrwanye wortdtchmr (jihvqdymgj, clwqbiupbf - wptxrlfjyr) View more	-	01 Aug 2022
NCT02543944 (GBN, CTgov)	Phase 2/3	Unspecified drug dependence	117	Naltrexone (depot)+Buprenorphine+Clonidine+Gabapentin+Naltrexone (oral) (Gabapentin)	oydndszeod(eauprupuuu) = ewesaisxzi hscdrnqbhl (dpivdgpbrv, 36.7) View more	-	28 Jul 2022
				Placebo+Naltrexone (depot)+Buprenorphine+Clonidine+Naltrexone (oral) (Placebo)	oydndszeod(eauprupuuu) = cacxrrzlrp hscdrnqbhl (dpivdgpbrv, 38.5) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis