# Lack of approved drug indications

**URL:** https://community.opentargets.org/t/lack-of-approved-drug-indications/327
**Category:** Data issue
**Tags:** ot-platform
**Created:** [25 August 2021 14:27 UTC](https://community.opentargets.org/t/lack-of-approved-drug-indications/327 "2021-08-25T14:27:39Z")
**Posts on this page:** 9
**Page:** 1

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### Author: ![sigven](https://dub1.discourse-cdn.com/flex017/user_avatar/community.opentargets.org/sigven/32/36_2.png) [@sigven](https://community.opentargets.org/u/sigven)
#### Post date: [25 August 2021 14:27 UTC](https://community.opentargets.org/t/lack-of-approved-drug-indications/327/1 "2021-08-25T14:27:40Z")

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Hi,

I cannot seem to make sense of the indications that are approved for particular drugs (cancer drugs in particular). It seems you now define “approved indication” when an indication is listed for the drug in a clinical trial with a maximum phase of IV. I reckoned this is the strategy, since this is in line with what is stated at the top _Description_ paragraph of the **Profile** tab for a given drug.

A couple of examples that shows the lack of approved indications:

1. Ipilimumab - a well-known immune checkpoint inhibitor that is now approved for [multiple cancer types](https://www.cancer.gov/about-cancer/treatment/drugs/ipilimumab). However, in the Open Targets Platform Portal, it seems this drug is only approved for [Melanoma](https://platform.opentargets.org/drug/CHEMBL1789844).

2. Olaparib - a well-known PARP inhibitor is now approved for [multiple tumor types](https://www.cancer.gov/about-cancer/treatment/drugs/olaparib). According to data from the Open Targets Platform, only [ovarian cancer](https://platform.opentargets.org/drug/CHEMBL521686) seems to be the approved (tumor-type specific) indication.

Unless I am interpreting the indication data in in unintended manner, I think these aspects are fairly important elements to improve/rectify in future releases.

Thanks again for a great resource,

best,  
Sigve

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### Author: ![ahercules](https://avatars.discourse-cdn.com/v4/letter/a/f4b2a3/32.png) [@ahercules](https://community.opentargets.org/u/ahercules)
#### Post date: [26 August 2021 17:52 UTC](https://community.opentargets.org/t/lack-of-approved-drug-indications/327/2 "2021-08-26T17:52:45Z")

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Hi @sigven! 👋

Thank you for alerting us to missing indications in our drug index.

The data we use to power our drug index is provided by our colleagues at ChEMBL. They integrate drug and indication data from a number of sources, including [ClinicalTrials.gov](http://ClinicalTrials.gov), ATC, DailyMed, and FDA.

If there are missing indications for a specific drug, please contact the ChEMBL team at [chembl-help@ebi.ac.uk](mailto:chembl-help@ebi.ac.uk). They can then update their database and when we process their latest release, it will update our drug index too.

Just out of curiosity, are there other research tools and platforms that you use to find drug indications? I am always interested to learn about the other tools our users rely on and will explore if we can potentially integrate their data.

Cheers,

Andrew 🙂

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### Author: ![sigven](https://dub1.discourse-cdn.com/flex017/user_avatar/community.opentargets.org/sigven/32/36_2.png) [@sigven](https://community.opentargets.org/u/sigven)
#### Post date: [26 August 2021 21:15 UTC](https://community.opentargets.org/t/lack-of-approved-drug-indications/327/3 "2021-08-26T21:15:51Z")

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Hi @ahercules,

Got it! I might approach ChEMBL with the observation. The thing is that the indications listed are all valid, it just seems to be a lag with respect to what is recorded in ChEMBL’s database and the continuous updates/additions of indications for different cancer drugs (i.e. by the FDA). With respect to other platforms, I have looked quite a bit, but I find that your platform is by far the strongest one, both with respect to structure, ease-of-use, and also up-to-date data for various knowledge sources. Some of the other larger drug databases (DrugBank, DrugCentral) are either missing this info or is not as comprehensive as I was hoping for. I’ll dig further to see whether any other tools/sources might be beneficial for your data integration routines.

Thanks for the swift feedback.

Regards,  
Sigve

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### Author: ![sigven](https://dub1.discourse-cdn.com/flex017/user_avatar/community.opentargets.org/sigven/32/36_2.png) [@sigven](https://community.opentargets.org/u/sigven)
#### Post date: [11 September 2023 08:43 UTC](https://community.opentargets.org/t/lack-of-approved-drug-indications/327/4 "2023-09-11T08:43:46Z")

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Hi, coming back to this issue.

I have now approached ChEMBL with the matter, since this is your primary source.

For cancers, it seems like there are a number of currently approved indications which are still missing in OT. Consider e.g. an immunotherapy drug like Nivolumab, which is now approved (frequently considering other criteria as well, e.g. presence of biomarkers, previous treatments etc.) for several tumor types:

> **[Nivolumab](https://www.cancer.gov/about-cancer/treatment/drugs/nivolumab)**
>
> Nivolumab is a type of targeted therapy drug called an immune checkpoint inhibitor (a type of immunotherapy). It is a monoclonal antibody that binds to the protein PD-1 on the surface of immune cells called T cells. It works by keeping cancer cells...

Using the Open Targets platform, i cannot see that this is approved for colorectal cancers, head and neck, or mesothelioma. It seems like there are still some rooms for improving this part. I am not really sure what is the best way to improve upon the matter, but I think awareness of the issue is warranted.

Thanks again for an incredible resource!

kind regards,  
Sigve

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### Author: ![irene](https://dub1.discourse-cdn.com/flex017/user_avatar/community.opentargets.org/irene/32/50_2.png) [@irene](https://community.opentargets.org/u/irene)
#### Post date: [11 September 2023 10:44 UTC](https://community.opentargets.org/t/lack-of-approved-drug-indications/327/5 "2023-09-11T10:44:49Z")

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Hi @sigven,

thank you for reporting this problem. We have documented the issue you reported, and the actions needed to reduce this mismatch you are observing. Please refer to our issue here:

> <https://github.com/opentargets/issues/issues/3065>
>
> An user from Community has reported that Nivolumab has missing approved indicati…ons compared to the information in \[Dailymed\](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394).
> Specifically, we only cover 4 of the 13 references we could be extracting from Dailymed.
> 
> \## Observed behaviour
> We collate information about clinical precedence through ChEMBL from 2 main sources:
> \- Clinical Trials. Reporting information for drugs across any phase of the clinical development
> \- Dailymed. Reporting information only for approved drugs
> 
> We have an asynchronism between the data we have, and what is reported in Dailymed. Specifically, \[the user is reporting\](https://community.opentargets.org/t/lack-of-approved-drug-indications/327/4?u=irene) that Nivolumab has been approved for colorectal cancers, head and neck, or mesothelioma, however we only display information for these indications up to the phase III CT.
> 
> This mismatch is very likely to be happening for other drugs.
> 
> \## Expected behaviour
> Dailymed's \[nivolumab\](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394) label information indeed collects this information.
> The dataset of indications is the combination of manual curation and an automated pipeline that extracts drug indications from Dailymed. We want to automatically parse Dailymed regularly to bring the mismatch between Dailymed and Open Targets to a minimum.
> 
> \## Tasks
> 
> \- \[\] Measure the extent of the problem.
> \- \[\] Discuss with ChEMBL the steps needed to regularly run the automated pipeline to have an up to date version of the indications
> \- ... Is there anything else we could be doing?
> 
> \## Acceptance tests
> 
> How do we know the task is complete? 
> 
> 1. Data: When I inspect the \`indications\` dataset and filter for \`CHEMBL2108738\`, I see that \`EFO\_0000181\`, \`EFO\_0000182\`, \`MONDO\_0007576\`, \`EFO\_1001480\`, \`MONDO\_0001056\`, \`EFO\_0000478\`, \`EFO\_0008528\`, \`EFO\_0000770\` have been added to the \`approvedIndications\` array.

We meet with ChEMBL regularly, so hopefully we’ll be able to provide detailed updates soon.

Thank you very much for your feedback,  
Irene

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### Author: ![sigven](https://dub1.discourse-cdn.com/flex017/user_avatar/community.opentargets.org/sigven/32/36_2.png) [@sigven](https://community.opentargets.org/u/sigven)
#### Post date: [14 September 2023 08:09 UTC](https://community.opentargets.org/t/lack-of-approved-drug-indications/327/6 "2023-09-14T08:09:13Z")

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Thanks a lot for rapid feedback! Looking forward to see future developments here:-)

kind regards,  
Sigve

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### Author: ![jasperhyp](https://dub1.discourse-cdn.com/flex017/user_avatar/community.opentargets.org/jasperhyp/32/186_2.png) [@jasperhyp](https://community.opentargets.org/u/jasperhyp)
#### Post date: [2 October 2023 00:45 UTC](https://community.opentargets.org/t/lack-of-approved-drug-indications/327/7 "2023-10-02T00:45:09Z")

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Hello, maybe DrugCentral would also be interesting?

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### Author: ![irene](https://dub1.discourse-cdn.com/flex017/user_avatar/community.opentargets.org/irene/32/50_2.png) [@irene](https://community.opentargets.org/u/irene)
#### Post date: [3 October 2023 08:31 UTC](https://community.opentargets.org/t/lack-of-approved-drug-indications/327/8 "2023-10-03T08:31:30Z")

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Hello @jasperhyp, @sigven

our colleagues at ChEMBL have explored including [EMA’s public assessment reports](https://www.ema.europa.eu/en/medicines/download-medicine-data) spreadsheets to maintain a high quality list of approved indications. For the case of Nivolumab, they could reproduce all 13 indications reported in Dailymed, so we think this will greatly help fill the gap of missing indications. However, it is also important to note that there might be discrepancies between approvals from FDA (as reported in Dailymed) and the EMA. We expect to see this take effect in the next ChEMBL 34 release.

Regarding Drugbank, this is a great resource that is free-to-access but unfortunately the use of their data requires a license.

Best,  
Irene

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<div class="post-metadata">

### Author: ![sigven](https://dub1.discourse-cdn.com/flex017/user_avatar/community.opentargets.org/sigven/32/36_2.png) [@sigven](https://community.opentargets.org/u/sigven)
#### Post date: [22 September 2025 13:34 UTC](https://community.opentargets.org/t/lack-of-approved-drug-indications/327/9 "2025-09-22T13:34:19Z")

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Hi,

Thanks again for a very good resource!

While I am not completely up-to-date as to how the drug indication data has evolved within your pipeline during the last couple of years, I wanted to highlight some observations.

I still see some **approved** drugs (e.g. [Abiraterone](https://platform.opentargets.org/drug/CHEMBL254328), [Bicalutamide](https://platform.opentargets.org/drug/CHEMBL409)) with indication _cancer/neoplasm_ listed for Max Phase IV (approved)_,_ while, to what I can figure out, the true indication(s) they are approved for are listed with a Max Phase of III.

One of the issues seems to be that drug entries listed in ATC are by default (?) linked only (?) to _cancer/neoplasm_ in OT - although it is stated (specifically for hormone therapies, e.g. [Bicalutamide](https://atcddd.fhi.no/atc_ddd_index/?code=L02BB03&showdescription=yes)) that the defined daily doses are defined for breast-, endometrial, and prostatic tumors (this is of course not unambiguous, but still). Also, still considering Bicalutamide, [the linked evidence from DailyMed](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=dfee4fe7-8478-4a3e-925d-00be3cd0ab67) indicates metastatic prostate cancer, although indication linked is _cancer/neoplasm._

Maybe these observations should be directed directly to ChEMBL - which contribute with the drug indication data (from what I understand), but wanted to post here as well.

My main observation is that, for some cancer conditions I have looked at, it’s still a bit challenging to get all approved drugs. I am not sure how extensive the issue is, though.

best,

Sigve
