Discontinued Radiopharmaceuticals

Below is a list of radiopharmaceuticals that have been discontinued over the years. While this list is not exhaustive, it offers valuable insights into compounds that, despite strong support from the radiopharmaceutical industry, were eventually withdrawn from the market for a variety of reasons. These discontinuations often stemmed from factors such as limited market demand, safety concerns, or the development of superior alternatives. The intention behind compiling this list is to shed light on the fate of these once-promising products, providing clarity on why they were ultimately pulled from the market.

The list also addresses questions regarding the local availability of these compounds and offers explanations for why their commercialization ceased. In cases where a product was withdrawn from one market but continues to be available in specific countries, this is noted. Understanding the reasons behind these withdrawals not only informs on past trends in the radiopharmaceutical industry but also highlights the challenges faced in maintaining a product’s place in a highly competitive and regulated field.

⁷⁵Se-Selenocholesterol (Scintadren^®)

⁷⁵Se-Selenocholesterol (also known as ⁷⁵Se-6-β-selenomethyl-norcholesterol) was primarily used for imaging the adrenal glands. It was marketed by Amersham Nycomed under the name Scintadren^®, which was established in 1979. This product is no longer available, as it was eventually replaced by its ¹³¹I-analogue, ¹³¹I-6-β-iodomethyl-norcholesterol (also known as ¹³¹I-NP-59 or ¹³¹I-Adosterol).

⁷⁵Se-Selenomethionine (Sethotope™)

⁷⁵Se-Selenomethionine, also known as Sethotope™, was the first amino acid-based radiopharmaceutical used in clinical scintillation scanning, with a primary application in pancreatic scintigraphy. It received its marketing authorization in 1973 and was available from several companies, including GE Healthcare, Mallinckrodt, Pharmalucence, and Bracco. However, it was discontinued due to its lack of specificity and the extended half-life of ⁷⁵Se (119.8 days).

⁹⁰Y-Yttrium Silicate

⁹⁰Y-Yttrium silicate, a therapeutic agent for radiosynovectomy, was marketed by GE Healthcare. It was withdrawn from the market in 2013 due to its limited market share and the presence of a more successful alternative, ⁹⁰Y-Yttrium citrate, which provided better sales despite having similar therapeutic properties.

^99mTc-Apcitide (Acutect™)

^99mTc-Apcitide (marketed as Acutect™) was a ^99mTc radiolabeled small molecule developed by Diatide for detecting deep vein thrombosis (DVT) in the lower extremity. Approved in 1998 and sold by Berlex (Schering Pharma/Bayer Healthcare), the product was withdrawn from the U.S. market in 2006 at the request of the marketing authorization holder.

^99mTc-Arcitumomab (CEAScan^®)

Developed by Immunomedics, CEAScan^® (99mTc-Arcitumomab) was a murine monoclonal antibody fragment used for detecting recurrent or metastatic colorectal cancer. Launched in the U.S. in 1996, it was withdrawn in both the U.S. and the EU by the authorization holder in 2005 due to commercial reasons. It remains available in the U.S. for research purposes, with a price around $1,200 per dose.

^99mTc-Depreotide (Neotect^® / Neospect^®)

^99mTc-Depreotide, a synthetic somatostatin analog, was marketed under the names Neotect^® in the U.S. and Neospect^® in Europe. It was used for scintigraphic imaging of suspected malignant lung tumors. Approved in 1999, its marketing authorization was withdrawn in 2006 at the request of the marketing authorization holder.

^99mTc-Fanolesomab (Neutrospec™)

^99mTc-Fanolesomab, branded as Neutrospec™, was a radiolabeled murine IgM antibody targeting CD15 receptors, used for diagnosing appendicitis. Released in the U.S. in 2004, its use was suspended in 2005 after life-threatening adverse events. It remains available for research in the U.S., priced at approximately $1,700 per dose.

^99mTc-HIG

^99mTc-Human Immunoglobulin (^99mTc-HIG) was developed as a polyclonal immunoglobulin tracer for bone scanning in rheumatoid arthritis and serum-negative polyarthritis patients. Despite being described in the 1980s, it was discontinued due to regulatory complexities in maintaining marketing authorization for polyclonal immunoglobulins. It remains available for research from Mallinckrodt.

^99mTc-Nofetumomab (Verluma^®)

^99mTc-Nofetumomab (Verluma^®) was used for diagnosing various cancers, including lung, breast, and ovarian carcinomas. Initially launched in the U.S. in 1996, the product was withdrawn in the early 2000s, with official discontinuation occurring in 2013.

^99mTc-Sulesomab (LeukoScan^®)

LeukoScan^® (^99mTc-Sulesomab) was a monoclonal antibody fragment used to detect infections and inflammation in bone, particularly osteomyelitis, and diabetic foot ulcers. Developed by Immunomedics, it was approved in the EU in 1997 and in Australia in 2005, but was eventually discontinued in 2018 after its marketing authorization was not extended.

^99mTc-Teboroxime (Cardiotec®)

Teboroxime (Cardiotec^®) was one of the early myocardial perfusion imaging agents. Approved by the FDA in 1990, it was discontinued around 2004 due to competition from superior alternatives such as ^99mTc-Sestamibi and 99mTc-Tetrofosmin. Interest in the tracer resurfaced recently due to advancements in SPECT imaging equipment.

^99mTc-Tecnemab-K1

Tecnemab-K1, a mouse antibody fragment labeled with ^99mTc for imaging cutaneous melanoma, was approved in both the U.S. (1996) and Europe (1997). However, it was withdrawn in 2000 due to limited clinical success.

^99mTc-Votumumab (HumaSPECT^®)

^99mTc-Votumumab (HumaSPECT®) was a human antibody developed for diagnosing colorectal cancer. It was withdrawn from the European market in 2003 due to poor sales.

¹¹¹In-Altumomab (Hybri-CEAker™)

Altumomab (¹¹¹In-Altumomab) was developed for imaging colorectal tumors and granted orphan drug status in 1990. Despite its potential, it was discontinued in 1997 due to limited clinical uptake.

¹¹¹In-Igovomab (Indimacis-125^®)

Indimacis-125^®, developed by CIS Bio International, was an ¹¹¹In-labeled imaging agent used for ovarian carcinoma detection. It was withdrawn in 1999 due to issues with the supply of the antibody.

¹¹¹In-Capromab pendetide (Prostascint^®)

Prostascint® (¹¹¹In-Capromab pendetide) was used for diagnosing prostate cancer, particularly in post-prostatectomy patients with rising PSA levels. Initially launched in 1997, it was eventually discontinued by Aytu Bioscience in 2018 due to competition from newer PET-based imaging agents.

¹¹¹In-Imciromab (Myoscint™)

Myoscint™ (¹¹¹In-Imciromab pentetate) was developed for myocardial injury detection. It was approved in both Europe and Japan in 1994 and 1996, respectively, but was withdrawn in 1999 due to high manufacturing costs.

¹¹¹In-Satumomab pendetide (Oncoscint CR103™)

Oncoscint™ (¹¹¹In-Satumomab pendetide) was developed for colorectal and ovarian cancer imaging. Despite its initial approval in 1996, it was withdrawn by 2000 due to lower efficacy compared to other imaging techniques.

¹²³I-Fatty Acids

¹²³I-labeled fatty acids, such as ¹²³I-Iodo Palmitic Acid, were used for myocardial imaging, particularly to assess areas affected by ischemic episodes. These tracers were replaced by ^99mTc-labeled agents like Sestamibi and Tetrofosmin, although ¹²³I-Iodofiltic acid (BMIPP) continues to be used in some cases.

¹²⁵I-Fibrinogen

¹²⁵I-Fibrinogen, previously sold by Abbott and GE Healthcare, was used for detecting deep vein thrombosis (DVT). The product has been discontinued, and no direct replacement is available.

¹³¹I-Fatty Acids

Similar to ¹²³I-labeled fatty acids, ¹³¹I-labeled fatty acids were withdrawn due to the advent of more effective ^99mTc-labeled imaging agents for myocardial perfusion imaging (MPI).

¹³¹I-Tositumomab (Bexxar^®)

¹³¹I-Tositumomab (Bexxar^®) was a monoclonal antibody developed for treating non-Hodgkin lymphoma (NHL). Despite its initial approval in the U.S. in 2003, it was withdrawn in 2014 due to limited clinical benefits over chemotherapy and safety concerns.

²²⁴Ra-Radium Chloride (224-SpondylAT^®)

²²⁴Ra-Radium Chloride was used for treating ankylosing spondylitis from the 1940s to the 1980s. It was reintroduced in 2000 under the name 224-SpondylAT^® but withdrawn in 2006 due to safety concerns, including an increased risk of leukemia and bone sarcomas.