
What Is Tianeptine? Warning Issued Over 'Gas Station Heroin'
Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content.
The U.S. Food and Drug Administration (FDA) has stepped up warnings about tianeptine, an unapproved antidepressant increasingly sold in gas stations and convenience stores under names like "Zaza," "Tianna," and "Neptune's Fix."
The substance, dubbed "gas station heroin" for its opioid-like effects, is illegal and not approved for medical use in the U.S., although it is legally marketed in some countries as an antidepressant.
Why It Matters
Tianeptine can be found in some gas stations and convenience stores, often with packaging that mimics legal supplements. Its misuse has drawn increasing attention, particularly due to the way it mimics the effects of opioids, and can cause serious and even fatal side effects.
According to the FDA, poison control center cases involving tianeptine exposure causing severe side effects have increased nationwide, from 11 in total between 2000 and 2013 to 151 in 2020 alone.
What To Know
Despite being illegal, the drug is sometimes illicitly added to foods and beverages or sold as a dietary supplement in the U.S. by some firms.
An FDA spokesperson told Newsweek: "The FDA has taken steps to protect people from tianeptine products, including warning consumers that tianeptine is an unsafe food additive."
The administration has also issued warning letters to companies distributing and selling unlawful tianeptine products, and issued import alerts to stop tianeptine shipments at the border.
A photo provided by the FDA in January 2024 shows bottles of Neptunes Fix Elixir, a product containing tianeptine.
A photo provided by the FDA in January 2024 shows bottles of Neptunes Fix Elixir, a product containing tianeptine.
Uncredited/FDA Office of Regulatory Affairs, Health Fraud Branch via AP
What Is Tianeptine?
Tianeptine acts on the brain's opioid receptors, which can produce feelings of euphoria at high doses, and the products feature claims—without evidence or FDA approval—that they can help users treat medical conditions, including addiction, pain and depression.
"Tianeptine has been used in tens of millions of patients over decades in Europe, Asia and South America and is well documented to be an antidepressant with efficacy roughly similar to first-line antidepressants," Dr. Jonathan A. Javitch, a professor at Columbia University, told Newsweek.
Tianeptine is taken recreationally by some, and has been used to self-treat a variety of ailments, as well as being used chronically. However, abruptly stopping it use can induce withdrawal symptoms similar to those associated with opioids, such as craving, sweating, diarrhea, and others.
"Despite this, it has a remarkably safe track record in Europe and the abuse rate when used clinically is extremely low," Javitch said.
He also said that used clinically, "there is no immediate perceptible effect on mood," and patients do not experience euphoria.
Javitch specializes in experimental therapeutics in psychiatry and is a professor of molecular pharmacology and therapeutics at Columbia.
"Doses six times the clinical dose were shown not to produce euphoria, and thus tianeptine works over time through changing brain chemistry and circuitry and synaptic structure," he said. However, he added that taking high doses in "an uncontrolled way is problematic."
Javitch stressed that he did not believe products containing tianeptine should be sold in "an uncontrolled way with little oversight over dosing or combination with other medication."
According to the FDA, reported adverse effects can include agitation, coma, confusion, death, drowsiness, hypertension, nausea, difficulty breathing, sweating, tachycardia (irregular heartbeat) and vomiting.
In 2024, there was a cluster of illnesses in New Jersey associated with the product "Neptune's Fix," which was found to contain tianeptine and synthetic cannabinoid receptor triggers. Adverse effects included tachycardia, seizure and even death.
FDA Crackdown
The FDA has been taking frequent steps in recent years to warn the public about the dangers of the drug, as well as trying to crack down on companies that include the ingredient in their products.
The agency recommends that health care professionals "encourage patients to avoid all products containing tianeptine, including those claiming to treat an ailment or disorder."
Instead, the FDA said they should speak to their patients about evidence-based treatment options for opioid use disorder, or cases of depression, anxiety, or pain.
States are also taking action independently, and currently a dozen have banned or restricted the sale of tianeptine, including Alabama, Georgia, Michigan, Minnesota, Ohio and Tennessee.
What People Are Saying
Dr. Jonathan A. Javitch, a professor at Columbia University, told Newsweek: "I don't think it should be available at gas stations in an uncontrolled way with little oversight over dosing or combination with other medication. I fear that people will use much higher doses than are clinically indicated, and can escalate dosing and mix with other compounds."
He added: "We just have to remember that tianeptine may have major potential as a treatment for depression and anxiety in the right patients, and we are trying to develop a precision psychiatry approach to predicting just which patients will respond to the mediation when used appropriately."
Commissioner of Food and Drugs Dr. Martin Makary said in a note last month on the subject: "I am very concerned. I want the public to be especially aware of this dangerous product and the serious and continuing risk it poses to America's youth.
"While the FDA is closely following the distribution and sale of these products, it is critical that you appreciate the magnitude of the underlying danger of these products, and disseminate information about it."
He added: "Historically, there has been a delayed recognition of fast-growing trends, such as opioid abuse and vaping addiction in youth. Let's be proactive in understanding and addressing the use of tianeptine products, which are available even to our nation's youth."
What Happens Next
The FDA said it will continue working with local and federal partners to crack down on illegal tianeptine products. It also urged consumers to report any adverse reactions involving tianeptine to the agency's MedWatch program.
This article contains reporting by The Associated Press.
Hashtags

Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles


Associated Press
6 hours ago
- Associated Press
Ascentage Pharma Announces Global Registrational Phase III Study of Lisaftoclax for First-line Treatment of Patients with Higher-Risk Myelodysplastic Syndrome Cleared by US FDA and EMA
ROCKVILLE, Md. and SUZHOU, China, Aug. 17, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, announced that it has received clearance by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to conduct GLORA-4 study (NCT06641414), a global registrational Phase III study of lisaftoclax (APG-2575), a proprietary Bcl-2 inhibitor, in combination with azacitidine (AZA), for the treatment of patients with newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS). This marks the second registrational Phase III study of lisaftoclax to receive clearance from both the FDA and EMA. The GLORA-4 study is simultaneously enrolling patients at participating centers in multiple countries, to accelerate the drug's path to potential market authorization. To date, lisaftoclax is the only Bcl-2 inhibitor being advanced in a registrational Phase III trial in higher-risk MDS globally. This study, if positive, may potentially end the longstanding treatment gap in higher-risk MDS, marking yet another major milestone in the global clinical development of lisaftoclax. Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, said, 'Globally, we still lack targeted therapies for first-line treatment of patients with higher-risk MDS, which represents a huge unmet clinical need. Currently, hypomethylating agents (HMA) and allogeneic hematopoietic stem cell transplantation (allo-HSCT) remain the primary treatment options for higher-risk MDS. In earlier studies, lisaftoclax has demonstrated promising clinical benefit and tolerability. The clearances of the GLORA-4 study by the U.S. FDA and EMA, coinciding with the approval by the China CDE, pave the way for lisaftoclax to potentially become the first Bcl-2 inhibitor approved globally for first-line treatment of higher-risk MDS and the first targeted therapy approved for this indication since the introduction of HMA, which fundamentally reshapes the treatment landscape.' The GLORA-4 trial is being conducted simultaneously in China, the U.S., and Europe. This will significantly accelerate the clinical development of lisaftoclax in MDS and accelerate the drug's path to potential market authorization. Moving forward, we will remain steadfastly committed to our mission of addressing unmet clinical needs in China and around the world, actively advancing our clinical programs for the benefit of more patients.' GLORA-4 is a multi-region, multi-center, randomized, double-blind Phase III trial designed to evaluate the efficacy and safety of lisaftoclax in combination with AZA compared to placebo plus AZA in newly diagnosed adult patients with higher-risk MDS. The study was originally approved by the China CDE in 2024. Currently, the study is enrolling patients globally, with the first patients already enrolled in China and Europe. Guillermo Garcia-Manero, MD, Chair of the Department of Leukemia, The University of Texas MD Anderson Cancer Center (MDACC), and Prof. Xiaojun Huang, MD, an academician of the Chinese Academy of Engineering, director of the Institute of Hematology at Peking University, and director of the Department of Hematology at Peking University People's Hospital, are global co-leading principal investigators of the study. MDS is a myeloid clonal disease originating from hematopoietic stem cells with strongly age-correlated characteristics. Global epidemiological data of MDS show an exponential increase in incidence with age (22/100,000 in the population aged over 65 years), with a median age of diagnosis of 70 years1. More than 75% of patients with MDS present a complex disease profile that includes at least two comorbidities2. The primary risk of MDS is clonal evolution leading to progression to acute myeloid leukemia (AML), with 40-60% of higher-risk patients (high/very high risk, as classified by IPSS-R) progressing to AML within five years3. These patients have a dismal prognosis and a median survival of less than six months4. As the standard first-line therapy for higher-risk MDS, HMAs offer inadequate responses to treatment, with an overall response rate (ORR) of just 30-40%5, a complete response (CR) rate of 10-17%, and a median duration of response of 9-12 months6, 8. While allo-HSCT can offer a potential cure, it is limited by the median age of patients, complex disease profiles, common depletion of the hematopoietic stem cell reserve, and a transplantation-related mortality (TRM) rate of 25-35%. As a result, only 5-10% of eligible patients can receive transplantation7. The five-year survival rate of patients who are classified by the IPSS-R as high-risk remains at 16-24%8, highlighting an urgent unmet medical need for innovative therapies that can change the treatment paradigm. Lisaftoclax is a proprietary, novel, orally administered Bcl-2 selective inhibitor being developed by Ascentage Pharma to treat patients with malignancies by selectively blocking the anti-apoptotic protein Bcl-2 and restoring the normal apoptosis process in cancer cells. Lisaftoclax is already approved in China for adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received at least one systemic therapy, including Bruton's tyrosine kinase (BTK) inhibitors. Previously, the Company released the clinical data of lisaftoclax in combination with AZA in treatment-naïve (TN) MDS during the 2024 American Society of Hematology (ASH) Annual Meeting and the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. These data showed an ORR of 75%, much higher than HMAs alone, which demonstrated the clinical benefit of the combination regimen. The combination also showed a favorable safety profile, with a low incidence of severe hematologic toxicities and neutropenia-related infections. In addition, the proportion of patients requiring dose adjustments was low and there were no treatment-related mortalities within 60 days9, 10. Professor Huang commented, 'Despite the significant advancement in the treatment of hematologic malignancies, higher-risk MDS remains a major clinical challenge because of a range of factors. First, the current standard of care treatment with HMAs only offers limited efficacy, with just about one-third of patients achieving a response to treatment. Second, no breakthrough therapies have emerged globally in the two decades since the introduction of HMAs. As a result, there is an unmet clinical need for targeted therapies for higher-risk MDS. The compelling response rate and manageable safety profile observed in earlier studies of lisaftoclax are very encouraging. We hope this global Phase III study has the potential to provide new insights that could benefit how we treat and manage higher-risk MDS.' Dr. Garcia-Manero commented, 'Higher-risk MDS is more prevalent in older populations and thus presents unique clinical challenges. These patients often have multiple comorbidities and depleted hematopoietic reserves, making them less tolerant of treatment with particularly high requirement for safety. Preliminary clinical data of lisaftoclax demonstrated notable clinical benefit, with low rates of treatment-related dose adjustments and mortalities while maintaining significant response rates. We hope these characteristics of lisaftoclax will make it a potentially superior treatment option for patients.' References: About Ascentage Pharma Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855) is a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer. The company has built a rich pipeline of innovative drug candidates that includes inhibitors targeting key proteins in the apoptotic pathway, such as Bcl-2 and MDM2-p53 and next-generation kinase inhibitors. The lead asset, olverembatinib, is the first novel third-generation BCR-ABL1 inhibitor approved in China for the treatment of patients with CML in chronic phase (CML-CP) with T315I mutations, CML in accelerated phase (CML-AP) with T315I mutations, and CML-CP that is resistant or intolerant to first and second-generation TKIs. It is covered by the China National Reimbursement Drug List (NRDL). The Company is currently conducting an FDA-cleared, global registrational Phase III trial, or POLARIS-2, of olverembatinib for CML, as well as global registrational Phase III trials for patients with newly diagnosed Ph+ ALL and SDH-deficient GIST. The second lead asset, lisaftoclax, is the first China-approved third-generation Bcl-2 inhibitor indicated for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received at least one systemic therapy, including Bruton's tyrosine kinase (BTK) inhibitors. The Company is currently conducting 4 global registrational Phase III trials: the GLORA study of lisaftoclax in combination with BTK inhibitors in patients with CLL/SLL who were previously treated with BTK inhibitors for more than 12 months with suboptimal response; the GLORA-2 study in patients with newly diagnosed CLL/SLL; the GLORA-3 study in newly diagnosed elderly and unfit patients with AML; and the GLORA-4 study in patients with newly diagnosed higher-risk MDS. Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships and other relationships with numerous leading biotechnology and pharmaceutical companies, such as Takeda, AstraZeneca, Merck, Pfizer, and Innovent, in addition to research and development relationships with leading research institutions, such as Dana-Farber Cancer Institute, Mayo Clinic, National Cancer Institute and the University of Michigan. For more information, visit Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, contained in this press release may be forward-looking statements, including statements that express Ascentage Pharma's opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results of operations or financial condition. These forward-looking statements are subject to a number of risks and uncertainties as discussed in Ascentage Pharma's filings with the SEC, including those set forth in the sections titled 'Risk factors' and 'Special note regarding forward-looking statements and industry data' in its Registration Statement on Form F-1, as amended, filed with the SEC on January 21, 2025, and the Form 20-F filed with the SEC on April 16, 2025, the sections headed 'Forward-looking Statements' and 'Risk Factors' in the prospectus of the Company for its Hong Kong initial public offering dated October 16, 2019, and other filings with the SEC and/or The Stock Exchange of Hong Kong Limited we made or make from time to time that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. The forward-looking statements contained in this presentation do not constitute profit forecast by the Company's management. As a result of these factors, you should not rely on these forward-looking statements as predictions of future events. The forward-looking statements contained in this press release are based on Ascentage Pharma's current expectations and beliefs concerning future developments and their potential effects and speak only as of the date of such statements. Ascentage Pharma does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Contact Information Investor Relations: Hogan Wan, Head of IR and Strategy Ascentage Pharma [email protected] +86 512 85557777 Stephanie Carrington ICR Healthcare [email protected] +1 (646) 277-1282 Media Relations: Jon Yu ICR Healthcare [email protected] +1 (646) 677-1855
Yahoo
8 hours ago
- Yahoo
MannKind (MNKD) Secures $500M Financing to Advance Inhaled Therapies Pipeline
We recently published . MannKind Corporation (NASDAQ:MNKD) is one of the best healthcare stocks. MannKind Corporation (NASDAQ:MNKD)'s most recent milestone is its push to expand the use of its rapid-acting inhaled insulin, Afrezza, to pediatric patients. In August 2025, the company submitted a supplemental Biologics License Application to the FDA for use in children ages 4–17, supported by positive Phase 3 INHALE-1 trial results presented at major diabetes conferences. A regulatory decision is expected in Q4 2025. Clinical data from both pediatric (INHALE-1) and adult (INHALE-3) studies have reinforced Afrezza's efficacy and safety across age groups. These advances have also helped the business gain attention among investors looking at the best healthcare stocks. Beyond Afrezza, MannKind Corporation (NASDAQ:MNKD) is advancing its pipeline in respiratory and rare diseases. MNKD-101, an inhaled clofazimine for nontuberculous mycobacterial lung disease, is progressing ahead of schedule in its global Phase 3 ICoN-1 trial. MNKD-201, a therapy for idiopathic pulmonary fibrosis, is set to enter Phase 2 testing by the end of 2025. Copyright: nicoletaionescu / 123RF Stock Photo To support these initiatives, the business secured up to $500 million in non-dilutive financing from Blackstone in August 2025. This funding will accelerate the potential launch of pediatric Afrezza, expand its commercial capabilities, and advance its clinical programs. Together, these developments position MannKind Corporation (NASDAQ:MNKD) for growth in both diabetes care and specialty lung disease markets. While we acknowledge the potential of MNKD as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: The Best and Worst Dow Stocks for the Next 12 Months and 10 Unstoppable Stocks That Could Double Your Money. Disclosure: None.
Yahoo
8 hours ago
- Yahoo
ImmunityBio (IBRX) Reports 60% Revenue Growth as ANKTIVA Adoption Accelerates
We recently published . ImmunityBio, Inc. (NASDAQ:IBRX) is one of the best healthcare stocks. ImmunityBio, Inc. (NASDAQ:IBRX) is among the best healthcare stocks. It is a clinical-stage biotech company developing advanced immunotherapies and vaccines targeting cancers and infectious diseases by activating immune cells such as natural killer and T cells. A key recent milestone is the FDA-approved immunotherapy drug ANKTIVA for bladder cancer, specifically for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS). ANKTIVA, designated a Breakthrough Therapy, is expanding its clinical use, notably with the Michael E. DeBakey VA Medical Center in Houston becoming one of the first VA hospitals to administer the treatment to veterans, a population at higher bladder cancer risk. In Q2 2025, ImmunityBio, Inc. (NASDAQ:IBRX) reported a 60% revenue growth quarter-over-quarter, reaching $26.4 million and a year-to-date total of approximately $43 million. This growth is driven by increased commercial momentum post-approval and supported by an $80 million capital raise in July 2025 to fuel ongoing development and expansion. ImmunityBio, Inc. (NASDAQ:IBRX) is transitioning from a clinical-stage biotech to a commercial-stage company with ANKTIVA's expanding adoption, including recent UK regulatory approval for ANKTIVA plus BCG. The drug addresses an underserved cancer indication with the potential to reduce invasive treatments like cystectomy, backed by clinical data showing durable bladder preservation up to 36 months in responders. While we acknowledge the potential of IBRX as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: The Best and Worst Dow Stocks for the Next 12 Months and 10 Unstoppable Stocks That Could Double Your Money. Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data