• Shalin Shah, CEO of Marius Pharmaceuticals, which makes an oral testosterone replacement drug, thinks TRT therapy should no longer be regulated as a controlled substance The post MedCity Pivot Podcast: Should Testosterone Replacement Therapy Be Less Regulated? • appeared first on MedCity News . • Shalin Shah, CEO of Marius Pharmaceuticals, which makes an oral testosterone replacement drug, thinks TRT therapy should no longer be regulated as a controlled substance The post MedCity Pivot Podcast: Should Testosterone Replacement Therapy Be Less Regulated? • appeared first on MedCity News .

Article Summaries:

  • In a recent MedCity Pivot Podcast, Shalin Shah, CEO of Marius Pharmaceuticals, argued that testosterone replacement therapy (TRT) should be removed from the controlled‑substance schedule. Shah, who leads a company developing an oral testosterone formulation, contended that stricter regulation limits patient access and stifles innovation. He highlighted safety data from his drug’s trials and suggested that existing prescription controls already mitigate abuse risks. The discussion also touched on broader regulatory trends, the potential impact on clinical practice, and the need for evidence‑based policy adjustments. The podcast concluded that reclassifying TRT could improve availability while maintaining safeguards.
  • A MedCity Pivot podcast featured Shalin Shah, CEO of Marius Pharmaceuticals, who argues that testosterone replacement therapy (TRT) should be removed from the list of controlled substances. Shah, whose company develops an oral TRT medication, said the current regulatory classification limits patient access and stifles innovation. He highlighted that oral testosterone offers a safer, more convenient alternative to injectable forms and that the drug‑controlled status creates unnecessary barriers for both prescribers and patients. The discussion focused on balancing safety concerns with the need for broader availability of TRT options.

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